Neoplasms
Conditions
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.
Interventions
DRUGJNJ-63898081
JNJ-63898081 will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum Prostate Specific Antigen (PSA) Concentration | Approximately 3 years | Serum prostate specific antigen (PSA) concentration will be assessed. |
| 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. |
| 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). |
| 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. |
| 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. |
Countries
Canada, United States
Outcome results
None listed