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出境医 / 临床实验 / PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors

PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors

Study Description
Brief Summary:
To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)

Condition or disease Intervention/treatment Phase
Solid Tumor Unresectable or Metastatic Melanoma Drug: CX-072 Drug: Ipilimumab Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
Actual Study Start Date : November 20, 2019
Actual Primary Completion Date : May 21, 2020
Actual Study Completion Date : May 21, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: CX-072 in combination with anti-cancer therapy-front line
histologically or cytologically confirmed solid tumor who have received no prior treatment
 Drug: CX-072
CX-072 in combination with ipilimumab
Experimental: CX-072 in combination with ipilimumab
histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
 Drug: CX-072
CX-072 in combination with ipilimumab

Drug: Ipilimumab
CX-072 in combination with ipilimumab
Experimental: CX-072 in combination with anti-cancer therapy-Progressed
histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy
 Drug: CX-072
CX-072 in combination with ipilimumab
Experimental: CX-072 in combination with anti-cancer therapy-Neoadjuvant
neo-adjuvant study in subjects with histologically confirmed solid tumor
 Drug: CX-072
CX-072 in combination with ipilimumab
Outcome Measures
Primary Outcome Measures :
  1. Overall response rate by RECIST v 1,1 [ Time Frame: 1 year ]
    ORR by RECIST v1.1


Secondary Outcome Measures :
  1. The percentage of patients experiencing Treatment Related Adverse Events [ Time Frame: 2 years ]
    Safety and Tolerability of CX-072 in Combination Therapy

  2. The numbers of patients experiencing anti-tumor activity by irRECIST [ Time Frame: 2 years ]
    ORR by irRECIST


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:

  1. At least 18 years of age
  2. Measurable disease as defined by RECIST v1.1
  3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  4. Agree to provide tumor tissue and blood samples for biomarker assessment

Exclusion Criteria:

  1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.
  2. Prior therapy with a chimeric antigen receptor T cell-containing regimen
  3. History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
  4. History of myocarditis regardless of the cause
  5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
  6. History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
  7. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic
Contacts and Locations

Locations
Show Show 27 study locations
Sponsors and Collaborators
CytomX Therapeutics
Investigators
Layout table for investigator information
Study Director: Lawrence Lu, MD CytomX Therapeutics
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE November 20, 2019
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019) 		Overall response rate by RECIST v 1,1 [ Time Frame: 1 year ]
ORR by RECIST v1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • The percentage of patients experiencing Treatment Related Adverse Events [ Time Frame: 2 years ]
    Safety and Tolerability of CX-072 in Combination Therapy
  • The numbers of patients experiencing anti-tumor activity by irRECIST [ Time Frame: 2 years ]
    ORR by irRECIST
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
Official Title  ICMJE A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors
Brief Summary To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Unresectable or Metastatic Melanoma
Intervention  ICMJE
  • Drug: CX-072
    CX-072 in combination with ipilimumab
  • Drug: Ipilimumab
    CX-072 in combination with ipilimumab
Study Arms  ICMJE
  • Experimental: CX-072 in combination with anti-cancer therapy-front line
    histologically or cytologically confirmed solid tumor who have received no prior treatment
    Intervention: Drug: CX-072
  • Experimental: CX-072 in combination with ipilimumab
    histologically or cytologically confirmed Stage III (unresectable) or Stage IV melanoma who have experienced progressive disease or relapse following treatment with a PD-1/PD-L1 immune checkpoint inhibitor
    Interventions:
    • Drug: CX-072
    • Drug: Ipilimumab
  • Experimental: CX-072 in combination with anti-cancer therapy-Progressed
    histologically or cytologically confirmed, advanced/unresectable or metastatic solid tumor that have experienced disease progression during or following treatment with platinum based therapy
    Intervention: Drug: CX-072
  • Experimental: CX-072 in combination with anti-cancer therapy-Neoadjuvant
    neo-adjuvant study in subjects with histologically confirmed solid tumor
    Intervention: Drug: CX-072
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 8, 2020) 		3
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		160
Actual Study Completion Date  ICMJE May 21, 2020
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. At least 18 years of age
  2. Measurable disease as defined by RECIST v1.1
  3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  4. Agree to provide tumor tissue and blood samples for biomarker assessment

Exclusion Criteria:

  1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.
  2. Prior therapy with a chimeric antigen receptor T cell-containing regimen
  3. History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
  4. History of myocarditis regardless of the cause
  5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
  6. History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
  7. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Korea, Republic of,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993379
Other Study ID Numbers  ICMJE CTMX-M-072-002
Has Data Monitoring Committee Yes
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
Plan to Share IPD: No
Responsible Party CytomX Therapeutics
Study Sponsor  ICMJE CytomX Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lawrence Lu, MD CytomX Therapeutics
PRS Account CytomX Therapeutics
Verification Date July 2020

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

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