Description:
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.
Title
- Brief Title: A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors
- Official Title: A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CR108593
- SECONDARY ID:
63898081EDI1001
- NCT ID:
NCT03926013
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| JNJ-63898081 | | Part 1: Dose Escalation |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part 1: Dose Escalation | Experimental | Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested. | |
| Part 2: Dose Expansion | Experimental | Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1. | |
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | 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. |
Secondary Outcome Measures
| Measure: | Part 1 and Part 2: Serum Concentrations of JNJ-63898081 |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | Serum samples will be analyzed to determine concentrations of JNJ-63898081 using a validated method. |
| Measure: | Part 1 and 2: Systemic Cytokine Concentrations |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | A panel of cytokines, including those proinflammatory ones, will be measured. |
| Measure: | Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | Anti-JNJ-63898081 antibodies will be evaluated in serum samples collected from all participants. |
| Measure: | Serum Prostate Specific Antigen (PSA) Concentration |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | Serum prostate specific antigen (PSA) concentration will be assessed. |
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | 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). |
| Measure: | Duration of Response |
| Time Frame: | Approximately 3 years |
| Safety Issue: | |
| Description: | 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). |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Janssen Research & Development, LLC |
Last Updated
July 21, 2021