Prostate Cancer Clinical Trial

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A Study of JNJ-78278343 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer

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Summary

The purpose of this study is to identify the recommended phase 2 doses (RP2Ds) of JNJ-78278343 with cetrelimab (JNJ-63723283) in Part 1 (dose escalation) and to determine safety at the RP2D(s) in Part 2 (dose expansion).

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Eligibility Criteria

Inclusion Criteria:

Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
Measurable or evaluable disease.
Prior treatment for mCRPC with at least 1 prior novel androgen receptor-targeted therapy (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (eg, docetaxel)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ functions

Exclusion Criteria:

Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy)
Solid organ or bone marrow transplantation
Known allergies, hypersensitivity, or intolerance to any of the components (eg, excipients) of JNJ-78278343 or cetrelimab
Significant infections or serious lung, heart or other medical conditions

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT05818683

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 3 Locations for this study

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Florida Cancer Specialists
Sarasota Florida, 34232, United States
Start Midwest
Grand Rapids Michigan, 49546, United States
Peter MacCallum Cancer Centre
Melbourne , 3000, Australia

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

20

Study ID:

NCT05818683

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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