A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors
Study Details
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 |
|---|---|---|
| Phase 1 |
Study Design
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
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [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) [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) [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
- Part 1 and Part 2: Serum Concentrations of JNJ-63898081 [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 [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 [Approximately 3 years]
Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants.
- Serum Prostate Specific Antigen (PSA) Concentration [Approximately 3 years]
Serum prostate specific antigen (PSA) concentration will be assessed.
- Objective Response Rate (ORR) [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 [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
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
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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.
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Evidence of disease progression on prior therapy that requires a new line of treatment
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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:
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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
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Prior treatment with prostate-specific membrane antigen (PSMA)-targeted therapy except for PSMA-targeted vaccine is permitted
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Solid organ or bone marrow transplantation
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Seizure or known condition that may predispose to seizure or intracranial masses
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Other active malignancy requiring systemic treatment <=12 months prior to enrollment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94158 |
| 2 | NIH Clinical Center | Bethesda | Maryland | United States | 20892 |
| 3 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 4 | University of Utah | Salt Lake City | Utah | United States | 84112 |
| 5 | University of Washington | Seattle | Washington | United States | 98195-9472 |
| 6 | British Columbia Cancer Agency | Vancouver | British Columbia | Canada | V5Z4E6 |
| 7 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108593
- 63898081EDI1001