A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors
- Registration Number
- NCT03926013
- Lead Sponsor
- Janssen Research & Development, LLC
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Dose Escalation JNJ-63898081 Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested. Part 2: Dose Expansion JNJ-63898081 Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1.
- Primary Outcome Measures
Name Time Method 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 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: 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
Name Time Method 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.
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).
Part 1 and 2: Systemic Cytokine Concentrations Approximately 3 years A panel of cytokines, including those proinflammatory ones, will be measured.
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).
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.
Trial Locations
- Locations (7)
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Washington
🇺🇸Seattle, Washington, United States
British Columbia Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Columbia University Medical Center
🇺🇸New York, New York, United States
NIH Clinical Center
🇺🇸Bethesda, Maryland, United States