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出境医 / 临床实验 / A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03)

A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03)

Study Description
Brief Summary:
A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU0132) in Subjects With Metastatic Solid Tumors

Condition or disease Intervention/treatment Phase
Metastatic Non-Small Cell Lung Carcinoma Head and Neck Squamous Cell Carcinoma Endometrial Cancer Biological: IMMU-132 Phase 2

Detailed Description:
This is a multi-cohort, open-label, Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in adult subjects with metastatic solid tumors.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Actual Study Start Date : August 6, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : November 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: IMMU-132
IMMU-132/Sacituzumab govitecan will be administered at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
 Biological: IMMU-132
Sacituzumab govitecan will be administered at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
Other Name: sacituzumab govitecan
Outcome Measures
Primary Outcome Measures :
  1. 1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment [ Time Frame: up to study completion, (average 32 months) ]
    ORR, is defined as the rate of the overall best response, complete response (CR) or partial response (PR), based on the investigator-assessed tumor response using RECIST 1.1 criteria.


Secondary Outcome Measures :
  1. 2. Overall Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment [ Time Frame: every 6 weeks from Cyle1 Day 1 for an average of 3 years, each cycle is 21 days ]
    ORR, is defined as the rate of the overall best response, CR or PR, by BICR using RECIST 1.1 criteria

  2. Duration of Response (DOR) According to RECIST 1.1 by BICR [ Time Frame: Up to Study Completion (average 3 years) ]
    DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first progression of disease (PD) or death according to RECIST 1.1 by BICR

  3. Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR [ Time Frame: up to 6 months ]
    CBR is defined as CR + PR + stable disease (SD) according to RECIST 1.1 by BICR

  4. Progression-free Survival (PFS) According to RECIST 1.1 by BICR [ Time Frame: Up to Study Completion (average 3 years) ]
    PFS, is defined as the time from first dose until objective tumor progression or death, whichever comes first according to RECIST 1.1 by BICR

  5. DOR According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to Study Completion (average 3 years) ]
    DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first PD or death based on the investigator-assessed tumor response using RECIST 1.1 criteria

  6. CBR According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to Study Completion (average 3 years) ]
    CBR, is defined as CR + PR + SD based on the investigator-assessed tumor response using RECIST 1.1 criteria

  7. PFS According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to Study Completion (average 3 years) ]
    PFS, is defined as the time from first dose until objective tumor progression or death, whichever comes first according to RECIST 1.1 based on the investigator-assessed tumor response using RECIST 1.1 criteria

  8. Trophoblast Cell-surface Antigen-2 (TROP-2) Expression Level [ Time Frame: Up to Study Completion (average 3 years) ]
    Trophoblast Cell-surface Antigen-2 (TROP-2) Expression Level

  9. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: First dose date up to last dose date plus 30 days (average: 3 years ]
    Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)

  10. Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs [ Time Frame: First dose date up to last dose date plus 30 days (average: 3 years) ]
    Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs

  11. Percentage of Participants with Clinically Significant Laboratory Changes [ Time Frame: First dose date up to last dose date plus 30 days (average: 3 years) ]
    Percentage of Participants with Clinically Significant Laboratory Changes

  12. Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab-Govitecan [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit. ]
    Cmax is defined as the maximum observed concentration of drug.

  13. Pharmacokinetic (PK) Parameter: AUC0-168h of Sacituzumab-Govitecan [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit ]
    AUC0-168h is defined as the concentration of drug over time between time 0 and time 168 hours

  14. Pharmacokinetic (PK) Parameter: Tmax of Sacituzumab-Govitecan [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit ]
    Tmax is defined as time to maximum observed concentration

  15. Immunogenicity Assessment [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit ]
    Number of participants who test positive for anti-drug antibodies to Sacituzumab-Govitecan will be reported


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male subjects, at least 18 years of age, able to understand and give written informed consent.
  • Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors. NSCLC. Tumor blocks (preferably, obtained within 12 months of study entry if clinically feasible) or 20 newly sectioned slides (6 minimum) of archived biopsy/surgical specimens are requested. these specimens should be submitted within 28 days before initiating Screening, after the subject provides written informed consent. A baseline biopsy is required if archival tissue is not available. Fine needle aspirations and bone biopsies are not suitable samples.

NSCLC (adenocarcinoma or SCC), that has progressed after prior platinum-based chemotherapy and PD-L1 or PD-1 directed therapy; recurrence/ relapse or lack of response within 6 months of completion of chemotherapy for locally advanced disease, that line of therapy may be counted for eligibility. Relapsed unresectable endometrial cancer that has progressed after prior platinum-based chemotherapy or is refractory to platinum-based chemotherapy.

Incurable, recurrent, or metastatic HNSCC that has progressed after prior platinum based chemotherapy and PD-LI or PD-1 directed therapy Relapsed unresectable endometrial cancer that has progressed after prior platinum based chemotherapy or is refactory to platinum based chemotherapy

  • Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1 (see Appendix 1)
  • Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
  • Adequate hepatic function
  • Subject must have at least a 3-month life expectancy.
  • Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (see Appendix 4). Tumor lesions situated in a previously irradiated area may be utilized if they are considered measurable and progression has been demonstrated in such lesions.

Exclusion Criteria:

Has has a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1

  • Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent
  • Have previously received topoisomerase I inhibitors
  • Have an active second malignancy
  • Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking ≤20 mg/day of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability
Contacts and Locations

Contacts
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Contact: Immunomedics Medical Information 888-983-4668 MedInfo@Immunomedics.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Chair: Cabilia Pichardo, MD Gilead Sciences
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date April 13, 2021
Actual Study Start Date  ICMJE August 6, 2019
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2021) 		1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Investigator's Assessment [ Time Frame: up to study completion, (average 32 months) ]
ORR, is defined as the rate of the overall best response, complete response (CR) or partial response (PR), based on the investigator-assessed tumor response using RECIST 1.1 criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019) 		Objective Tumor Response Rates as assessed by RECIST 1.1 by Investigator Assessment [ Time Frame: through study completion, an average of 6 months ]
Assess the clinical activity of sacituzumab govitecan in subjects with metastatic solid tumors according to objective tumor response rates through study completion, an average of 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2021)
  • 2. Overall Response Rate (ORR) According to RECIST 1.1 by Blinded Independent Central Review (BICR) Assessment [ Time Frame: every 6 weeks from Cyle1 Day 1 for an average of 3 years, each cycle is 21 days ]
    ORR, is defined as the rate of the overall best response, CR or PR, by BICR using RECIST 1.1 criteria
  • Duration of Response (DOR) According to RECIST 1.1 by BICR [ Time Frame: Up to Study Completion (average 3 years) ]
    DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first progression of disease (PD) or death according to RECIST 1.1 by BICR
  • Clinical Benefit Rate (CBR) According to RECIST 1.1 by BICR [ Time Frame: up to 6 months ]
    CBR is defined as CR + PR + stable disease (SD) according to RECIST 1.1 by BICR
  • Progression-free Survival (PFS) According to RECIST 1.1 by BICR [ Time Frame: Up to Study Completion (average 3 years) ]
    PFS, is defined as the time from first dose until objective tumor progression or death, whichever comes first according to RECIST 1.1 by BICR
  • DOR According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to Study Completion (average 3 years) ]
    DOR, is calculated as the date of the first evaluation showing documented response, either PR or CR, to the date of the first PD or death based on the investigator-assessed tumor response using RECIST 1.1 criteria
  • CBR According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to Study Completion (average 3 years) ]
    CBR, is defined as CR + PR + SD based on the investigator-assessed tumor response using RECIST 1.1 criteria
  • PFS According to RECIST 1.1 by Investigator's Assessment [ Time Frame: Up to Study Completion (average 3 years) ]
    PFS, is defined as the time from first dose until objective tumor progression or death, whichever comes first according to RECIST 1.1 based on the investigator-assessed tumor response using RECIST 1.1 criteria
  • Trophoblast Cell-surface Antigen-2 (TROP-2) Expression Level [ Time Frame: Up to Study Completion (average 3 years) ]
    Trophoblast Cell-surface Antigen-2 (TROP-2) Expression Level
  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) [ Time Frame: First dose date up to last dose date plus 30 days (average: 3 years ]
    Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)
  • Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs [ Time Frame: First dose date up to last dose date plus 30 days (average: 3 years) ]
    Percentage of Participants Experiencing Treatment-Emergent Serious Adverse Events (SAEs
  • Percentage of Participants with Clinically Significant Laboratory Changes [ Time Frame: First dose date up to last dose date plus 30 days (average: 3 years) ]
    Percentage of Participants with Clinically Significant Laboratory Changes
  • Pharmacokinetic (PK) Parameter: Cmax of Sacituzumab-Govitecan [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit. ]
    Cmax is defined as the maximum observed concentration of drug.
  • Pharmacokinetic (PK) Parameter: AUC0-168h of Sacituzumab-Govitecan [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit ]
    AUC0-168h is defined as the concentration of drug over time between time 0 and time 168 hours
  • Pharmacokinetic (PK) Parameter: Tmax of Sacituzumab-Govitecan [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit ]
    Tmax is defined as time to maximum observed concentration
  • Immunogenicity Assessment [ Time Frame: Up to Study Completion (average 3 years) and at 30-Day Safety Follow-up Visit ]
    Number of participants who test positive for anti-drug antibodies to Sacituzumab-Govitecan will be reported
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Overall Response Rate (ORR) according to RECIST 1.1 by BICR and Investigator assessed [ Time Frame: every 6 weeks from Cyle1 Day 1 for 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years ]
    Overall Response Rate (ORR) , according to RECIST 1.1 by BICR and Investigator Assessment
  • Duration of Response (DUR) according to RECIST 1.1 by BICR and Investigator assessed [ Time Frame: Every 6 weeks from Cyle1 Day 1 for 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years ]
    Duration Of Response (DUR) according to RECIST 1.1 by BICR and Investigator Assessment
  • Progression free Survival (PFS) according to RECIST 1.1 by BICR and Investigator assessed [ Time Frame: Every 6 weeks from Cyle1 Day 1 for 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years ]
    Progression Free Survival (PFS) according to RECIST 1.1 by BICR and Investigator Assessment
  • Assess safety evaluated by adverse events and serious adverse events as assessed by CTCAE v.5.0 [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess the safety evaluated by adverse events and serious adverse events
  • Assess Safety as evaluated by blood pressure ( in mm/hg) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as evaluated by blood pressure ( in mm/hg)
  • Assess Safety as evaluated by heart rate (beats per minute) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as evaluated by heart rate (beats per minute)
  • Assess Safety as evaluated by respiratory rate (breaths per minute) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as evaluated by respiratory rate (breaths per minute)
  • Assess Safety as evaluated by body temperature (Celsius) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Asess Safety as evaluated by body temperature (Celsius)
  • Assess Safety as assessed by laboratory changes in complete blood count (CBC) (including white blood cell count, hemoglobin,platelet count and neutrophil count) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as assessed by laboratory changes in complete blood count (CBC) (including white blood cell count, hemoglobin,platelet count and neutrophil count
  • Assess Safety as assessed by laboratory changes in chemistry including electrolytes (sodium, potassium, biocarbonate, sreum creatinine) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as assessed by laboratory changes in chemistry including electrolytes (sodium, potassium, biocarbonate, sreum creatinine)
  • Trop-2 expression level and relationship with efficacy outcome overall response rate [ Time Frame: At end of treatment, and average of 6 months and 30 days following last dose up to 24 months ]
    Assess baseline Trop-2 expression and correlate to Overall response rate (ORR)
  • Trop-2 expression level and relationship with efficacy outcome Progression free survival [ Time Frame: At end of treatment, and average of 6 months and 30 days following last dose up to 24 months ]
    Assess baseline Trop-2 expression and correlate to Progression Free Survival (PFS)
  • Trop-2 expression level and relationship with efficacy outcome overall survival [ Time Frame: At end of treatment, and average of 6 months and 30 days following last dose up to 24 months ]
    Assess baseline Trop-2 expression and correlate to overall survival
  • Assess Serum PK parameter Plasma Concentration (Cmax) [ Time Frame: through treatment completion, an average of 6 months ]
    Assess Serum PK parameter Plasma Concentration (Cmax)
  • Assess Serum PK parameter Area Under the Curve (AUC) [ Time Frame: through treatment completion, an average of 6 months ]
    Assess Serum PK parameters including AUC,
  • Assess Serum PK parameter Time to reach maximum concentration (Tmax) [ Time Frame: through treatment completion, an average of 6 months ]
    Assess Serum PK parameter Tmax
  • Assess Anti-drug Antibody (ADA) Concentration [ Time Frame: through treatment completion, an average of 6 months ]
    Assess ADA Concentration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 24, 2019)
  • Assess DNA repair genes BRCA2 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA2 and correlate to overall survival [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA2 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA1 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including to BRCA1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA1 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes BRCA1 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes RAD51 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including Rad51 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK1 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK2 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK3 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK3 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATM and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATM at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes RAD51 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including RAD51 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATM and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATM at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK1 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK2 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK3 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK3 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes RAD51 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including RAD51 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATM and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATM at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK2 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK2 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK1 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK1 at baseline and correlate with efficacy outcomes
  • Assess DNA repair genes ATK3 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK3 at baseline and correlate with efficacy outcomes
 
Descriptive Information
Brief Title  ICMJE A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (TROPICS-03)
Official Title  ICMJE A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Brief Summary A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU0132) in Subjects With Metastatic Solid Tumors
Detailed Description This is a multi-cohort, open-label, Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in adult subjects with metastatic solid tumors.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Non-Small Cell Lung Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Endometrial Cancer
Intervention  ICMJE Biological: IMMU-132
Sacituzumab govitecan will be administered at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
Other Name: sacituzumab govitecan
Study Arms  ICMJE Experimental: IMMU-132
IMMU-132/Sacituzumab govitecan will be administered at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
Intervention: Biological: IMMU-132
Publications *
  • Goldenberg DM, Stein R, Sharkey RM. The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target. Oncotarget. 2018 Jun 22;9(48):28989-29006. doi: 10.18632/oncotarget.25615. eCollection 2018 Jun 22. Review.
  • Gray JE, Heist RS, Starodub AN, Camidge DR, Kio EA, Masters GA, Purcell WT, Guarino MJ, Misleh J, Schneider CJ, Schneider BJ, Ocean A, Johnson T, Gandhi L, Kalinsky K, Scheff R, Messersmith WA, Govindan SV, Maliakal PP, Mudenda B, Wegener WA, Sharkey RM, Goldenberg DM. Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Clin Cancer Res. 2017 Oct 1;23(19):5711-5719. doi: 10.1158/1078-0432.CCR-17-0933. Epub 2017 Jul 5.
  • Ocean AJ, Starodub AN, Bardia A, Vahdat LT, Isakoff SJ, Guarino M, Messersmith WA, Picozzi VJ, Mayer IA, Wegener WA, Maliakal P, Govindan SV, Sharkey RM, Goldenberg DM. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. Cancer. 2017 Oct 1;123(19):3843-3854. doi: 10.1002/cncr.30789. Epub 2017 May 30.
  • Heist RS, Guarino MJ, Masters G, Purcell WT, Starodub AN, Horn L, Scheff RJ, Bardia A, Messersmith WA, Berlin J, Ocean AJ, Govindan SV, Maliakal P, Mudenda B, Wegener WA, Sharkey RM, Goldenberg DM, Camidge DR. Therapy of Advanced Non-Small-Cell Lung Cancer With an SN-38-Anti-Trop-2 Drug Conjugate, Sacituzumab Govitecan. J Clin Oncol. 2017 Aug 20;35(24):2790-2797. doi: 10.1200/JCO.2016.72.1894. Epub 2017 May 26.
  • Bourauel C, Drescher D, Nolte LP. [The computer-aided development of orthodontic treatment elements made from NiTi memory alloys exemplified by a pseudoelastic retraction spring]. Fortschr Kieferorthop. 1993 Feb;54(1):45-56. German. Erratum in: Fortschr Kieferorthop 1993 Apr;54(2):9.
  • Bardia A, Mayer IA, Diamond JR, Moroose RL, Isakoff SJ, Starodub AN, Shah NC, O'Shaughnessy J, Kalinsky K, Guarino M, Abramson V, Juric D, Tolaney SM, Berlin J, Messersmith WA, Ocean AJ, Wegener WA, Maliakal P, Sharkey RM, Govindan SV, Goldenberg DM, Vahdat LT. Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer. J Clin Oncol. 2017 Jul 1;35(19):2141-2148. doi: 10.1200/JCO.2016.70.8297. Epub 2017 Mar 14.
  • Cardillo TM, Sharkey RM, Rossi DL, Arrojo R, Mostafa AA, Goldenberg DM. Synthetic Lethality Exploitation by an Anti-Trop-2-SN-38 Antibody-Drug Conjugate, IMMU-132, Plus PARP Inhibitors in BRCA1/2-wild-type Triple-Negative Breast Cancer. Clin Cancer Res. 2017 Jul 1;23(13):3405-3415. doi: 10.1158/1078-0432.CCR-16-2401. Epub 2017 Jan 9.
  • Faltas B, Goldenberg DM, Ocean AJ, Govindan SV, Wilhelm F, Sharkey RM, Hajdenberg J, Hodes G, Nanus DM, Tagawa ST. Sacituzumab Govitecan, a Novel Antibody--Drug Conjugate, in Patients With Metastatic Platinum-Resistant Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):e75-9. doi: 10.1016/j.clgc.2015.10.002. Epub 2015 Oct 19.
  • Sharkey RM, McBride WJ, Cardillo TM, Govindan SV, Wang Y, Rossi EA, Chang CH, Goldenberg DM. Enhanced Delivery of SN-38 to Human Tumor Xenografts with an Anti-Trop-2-SN-38 Antibody Conjugate (Sacituzumab Govitecan). Clin Cancer Res. 2015 Nov 15;21(22):5131-8. doi: 10.1158/1078-0432.CCR-15-0670. Epub 2015 Jun 23.
  • Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Oncotarget. 2015 Sep 8;6(26):22496-512. Erratum in: Oncotarget. 2020 Mar 10;11(10):942.
  • Starodub AN, Ocean AJ, Shah MA, Guarino MJ, Picozzi VJ Jr, Vahdat LT, Thomas SS, Govindan SV, Maliakal PP, Wegener WA, Hamburger SA, Sharkey RM, Goldenberg DM. First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Clin Cancer Res. 2015 Sep 1;21(17):3870-8. doi: 10.1158/1078-0432.CCR-14-3321. Epub 2015 May 5.
  • Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Arrojo R, Liu D, Rossi EA, Chang CH, Goldenberg DM. Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. Bioconjug Chem. 2015 May 20;26(5):919-31. doi: 10.1021/acs.bioconjchem.5b00223. Epub 2015 May 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2021) 		200
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2019) 		600
Estimated Study Completion Date  ICMJE November 2024
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female or male subjects, at least 18 years of age, able to understand and give written informed consent.
  • Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors. NSCLC. Tumor blocks (preferably, obtained within 12 months of study entry if clinically feasible) or 20 newly sectioned slides (6 minimum) of archived biopsy/surgical specimens are requested. these specimens should be submitted within 28 days before initiating Screening, after the subject provides written informed consent. A baseline biopsy is required if archival tissue is not available. Fine needle aspirations and bone biopsies are not suitable samples.

NSCLC (adenocarcinoma or SCC), that has progressed after prior platinum-based chemotherapy and PD-L1 or PD-1 directed therapy; recurrence/ relapse or lack of response within 6 months of completion of chemotherapy for locally advanced disease, that line of therapy may be counted for eligibility. Relapsed unresectable endometrial cancer that has progressed after prior platinum-based chemotherapy or is refractory to platinum-based chemotherapy.

Incurable, recurrent, or metastatic HNSCC that has progressed after prior platinum based chemotherapy and PD-LI or PD-1 directed therapy Relapsed unresectable endometrial cancer that has progressed after prior platinum based chemotherapy or is refactory to platinum based chemotherapy

  • Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1 (see Appendix 1)
  • Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
  • Adequate hepatic function
  • Subject must have at least a 3-month life expectancy.
  • Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (see Appendix 4). Tumor lesions situated in a previously irradiated area may be utilized if they are considered measurable and progression has been demonstrated in such lesions.

Exclusion Criteria:

Has has a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, radiation therapy within 2 weeks prior to Study Day 1

  • Have not recovered (i.e., ≤ Grade 1) from adverse events due to a previously administered agent
  • Have previously received topoisomerase I inhibitors
  • Have an active second malignancy
  • Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking ≤20 mg/day of prednisone or its equivalent. All subjects with carcinomatous meningitis are excluded regardless of clinical stability
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Immunomedics Medical Information 888-983-4668 MedInfo@Immunomedics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03964727
Other Study ID Numbers  ICMJE Immu-132-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Cabilia Pichardo, MD Gilead Sciences
PRS Account Gilead Sciences
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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