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

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ClinicalTrials.gov Identifier: NCT03926013
Recruitment Status : Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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)
Actual Enrollment : 40 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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926013


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94158
United States, Maryland
NIH Clinical Center
Bethesda, Maryland, United States, 20892
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-9472
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z4E6
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03926013    
Other Study ID Numbers: CR108593
63898081EDI1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No