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出境医 / 临床实验 / A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors

A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors

Study Description
Brief Summary:
The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: JNJ-63898081 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : August 12, 2021
Estimated Study Completion Date : November 7, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Part 1: Dose Escalation
Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested.
 Drug: JNJ-63898081
JNJ-63898081 will be administered.
Experimental: Part 2: Dose Expansion
Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1.
 Drug: JNJ-63898081
JNJ-63898081 will be administered.
Outcome Measures
Primary Outcome Measures :
  1. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Approximately 3 years ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  2. Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Approximately 3 years ]
    Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

  3. Part 1: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: Approximately 3 years ]
    Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.


Secondary Outcome Measures :
  1. Part 1 and Part 2: Serum Concentrations of JNJ-63898081 [ Time Frame: Approximately 3 years ]
    Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method.

  2. Part 1 and 2: Systemic Cytokine Concentrations [ Time Frame: Approximately 3 years ]
    A panel of cytokines, including those proinflammatory ones, will be measured.

  3. Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies [ Time Frame: Approximately 3 years ]
    Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants.

  4. Serum Prostate Specific Antigen (PSA) Concentration [ Time Frame: Approximately 3 years ]
    Serum prostate specific antigen (PSA) concentration will be assessed.

  5. Objective Response Rate (ORR) [ Time Frame: Approximately 3 years ]
    ORR is defined as the proportion of participants who have a PR or better according to the disease-specific response criteria. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).

  6. Duration of Response [ Time Frame: Approximately 3 years ]
    Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).


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:

  • Histology: Part 1: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed. mCRPC is defined by prostate Cancer Working Group (PCWG )3 criteria. Part 2: mCRPC as defined above or pathologically confirmed metastatic renal cell carcinoma (RCC) as defined by world health organization (WHO) 2016 Classifications
  • Measurable or evaluable disease: Part 1: Either measurable or evaluable disease for prostate cancer. Part 2: At least one measurable lesion as per RECIST v1.1.
  • Evidence of disease progression on prior therapy that requires a new line of treatment
  • Participants with accessible lesions enrolled in selected pharmacokinetic (PK)/pharmacodynamics (PD) cohorts and in Part 2 must agree to undergo the mandatory fresh tumor biopsies, unless collection of the biopsy presents a safety risk

Exclusion Criteria:

  • Less than 2 weeks between prior anticancer treatment (including radiotherapy) discontinuation and the first dose of study drug, and toxicities have not returned to Grade less than or equal to (<=) 1 or baseline
  • Prior treatment with prostate-specific membrane antigen (PSMA)-targeted therapy except for PSMA-targeted vaccine is permitted
  • Solid organ or bone marrow transplantation
  • Seizure or known condition that may predispose to seizure or intracranial masses
  • Other active malignancy requiring systemic treatment <=12 months prior to enrollment
Contacts and Locations

Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94158
United States, Maryland
NIH Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195-9472
Canada, British Columbia
British Columbia Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z4E6
Canada, Ontario
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
France
Institut Bergonié Not yet recruiting
Bordeaux, France, 33000
Centre Leon Bérard Not yet recruiting
Lyon Cedex 8, France, 69373
Hopital de la Timone Not yet recruiting
Marseille, France, 13005
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94800
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE April 24, 2019
Last Update Posted Date January 29, 2021
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date August 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Approximately 3 years ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
  • Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) [ Time Frame: Approximately 3 years ]
    Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
  • Part 1: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: Approximately 3 years ]
    Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2019)
  • Part 1 and Part 2: Serum Concentrations of JNJ-63898081 [ Time Frame: Approximately 3 years ]
    Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method.
  • Part 1 and 2: Systemic Cytokine Concentrations [ Time Frame: Approximately 3 years ]
    A panel of cytokines, including those proinflammatory ones, will be measured.
  • Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies [ Time Frame: Approximately 3 years ]
    Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants.
  • Serum Prostate Specific Antigen (PSA) Concentration [ Time Frame: Approximately 3 years ]
    Serum prostate specific antigen (PSA) concentration will be assessed.
  • Objective Response Rate (ORR) [ Time Frame: Approximately 3 years ]
    ORR is defined as the proportion of participants who have a PR or better according to the disease-specific response criteria. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).
  • Duration of Response [ Time Frame: Approximately 3 years ]
    Duration of response (DOR) will be calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the disease-specific response criteria, or death due to any cause, whichever occurs first. Evaluation of prostate treatment response will be performed according to Prostate Cancer Working Group 3 (PCWG3).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2019)
  • Part 1 and Part 2: Serum Concentrations of JNJ-63898081 [ Time Frame: Approximately 3 years ]
    Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method.
  • Part 1 and 2: Systemic Cytokine Concentrations [ Time Frame: Approximately 3 years ]
    A panel of cytokines, including those proinflammatory ones, will be measured.
  • Part 1 and 2: Concentration of Markers of T-Cell Activation [ Time Frame: Approximately 3 years ]
    Markers of T-cell activation/exhaustion as well as immunophenotyping will be assessed.
  • Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies [ Time Frame: Approximately 3 years ]
    Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants.
  • Serum Prostate Specific Antigen (PSA) Concentration [ Time Frame: Approximately 3 years ]
    Serum prostate specific antigen (PSA) concentration will be assessed.
  • Percentage of JNJ-63898081 Receptor Occupancy [ Time Frame: Approximately 3 years ]
    Percentage of JNJ-63898081 receptor occupancy will be assessed via flow cytometry.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors
Official Title  ICMJE A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors
Brief Summary The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE Drug: JNJ-63898081
JNJ-63898081 will be administered.
Study Arms  ICMJE
  • Experimental: Part 1: Dose Escalation
    Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested.
    Intervention: Drug: JNJ-63898081
  • Experimental: Part 2: Dose Expansion
    Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1.
    Intervention: Drug: JNJ-63898081
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2019) 		90
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2019) 		70
Estimated Study Completion Date  ICMJE November 7, 2022
Estimated Primary Completion Date August 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histology: Part 1: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed. mCRPC is defined by prostate Cancer Working Group (PCWG )3 criteria. Part 2: mCRPC as defined above or pathologically confirmed metastatic renal cell carcinoma (RCC) as defined by world health organization (WHO) 2016 Classifications
  • Measurable or evaluable disease: Part 1: Either measurable or evaluable disease for prostate cancer. Part 2: At least one measurable lesion as per RECIST v1.1.
  • Evidence of disease progression on prior therapy that requires a new line of treatment
  • Participants with accessible lesions enrolled in selected pharmacokinetic (PK)/pharmacodynamics (PD) cohorts and in Part 2 must agree to undergo the mandatory fresh tumor biopsies, unless collection of the biopsy presents a safety risk

Exclusion Criteria:

  • Less than 2 weeks between prior anticancer treatment (including radiotherapy) discontinuation and the first dose of study drug, and toxicities have not returned to Grade less than or equal to (<=) 1 or baseline
  • Prior treatment with prostate-specific membrane antigen (PSMA)-targeted therapy except for PSMA-targeted vaccine is permitted
  • Solid organ or bone marrow transplantation
  • Seizure or known condition that may predispose to seizure or intracranial masses
  • Other active malignancy requiring systemic treatment <=12 months prior to enrollment
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: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Canada,   France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926013
Other Study ID Numbers  ICMJE CR108593
63898081EDI1001 ( Other Identifier: Janssen Research & Development, LLC )
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
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date January 2021

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

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