A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
Conditions
Advanced Prostate CancerDrugs
JNJ-78278343, JNJ-87189401Summary
The purpose of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 (Part 1: dose escalation) and further evaluate the safety at RP2Rs (Part 2: dose expansion) in participants with advanced prostate cancer.
Locations
3 locations Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Study Contact
- 844-434-4210
- [email protected]
Study Director
- Janssen Research & Development, LLC Clinical Trial
Status
- RECRUITING
Central Contacts
- Study Contact
- 844-434-4210
- [email protected]
Study Director
- Janssen Research & Development, LLC Clinical Trial
Status
- RECRUITING
Central Contacts
- Study Contact
- 844-434-4210
- [email protected]
Study Director
- Janssen Research & Development, LLC Clinical Trial
Eligibility Criteria
Inclusion Criteria:
* Metastatic castration-resistant prostate cancer (mCRPC) as defined by Prostate Cancer Working Group 3 (PCWG3): Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
* Measurable or evaluable disease per PCWG3 criteria; all participants must have a serum PSA value greater than or equal to (>=2) nanograms per milliliter (ng/mL) at time of screening
* Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications (example, chronic corticosteroids, methotrexate, or tacrolimus)
* Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
Study Plan
Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
EXPERIMENTAL
Participants will receive JNJ-78278343+JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). Participants will receive the combination treatment at the RP2R in Part 2 (dose expansion).
DRUG:
JNJ-78278343Description:
JNJ-78278343 will be administered.DRUG:
JNJ-87189401Description:
JNJ-87189401 will be administered.
Outcome Measures
Primary Outcome Measures
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
Secondary Outcome Measures
Part 2: Serum Concentration of JNJ-87189401
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Objective Response Rate (ORR)
Prostate Specific Antigen (PSA) Response Rate
Duration of Response (DOR)
Timeline
Last Updated
October 21, 2024Start Date
October 23, 2023Today
January 16, 2025Completion Date ( Estimated )
June 21, 2027
Sponsors of this trial
Lead Sponsor
Janssen Research & Development, LLC