A Study of JNJ-78278343 in Combination With JNJ-63723283 (Cetrelimab) for Metastatic Castration-Resistant Prostate Cancer
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JNJ-78278343 + Cetrelimab: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) Participants will receive subcutaneous (SC) administration of JNJ-78278343 in combination with intravenous (IV) infusion of cetrelimab during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 dose (RP2D). Participants will receive the combination treatment at the RP2D in Part 2 (dose expansion) |
Drug: JNJ-78278343
JNJ-78278343 will be administered subcutaneously.
Drug: Cetrelimab
Cetrelimab will be administered by intravenous infusion.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Part 1: Number of Participants With Dose Limiting Toxicity (DLT) [Up to 21 days after first dose of cetrelimab]
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) by Severity [Up to 2 years 10 months]
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. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Secondary Outcome Measures
- Overall Response Rate (ORR) [Up to 2 years 10 months]
ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria.
- Prostate Specific Antigen (PSA) Response Rate [Up to 2 years 10 months]
PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
- Duration of Response (DOR) [Up to 2 years 10 months]
DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
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Measurable or evaluable disease.
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Prior treatment for mCRPC with at least 1 prior novel androgen receptor-targeted therapy (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (eg, docetaxel)
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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Adequate organ functions
Exclusion Criteria:
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Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
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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)
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Solid organ or bone marrow transplantation
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Known allergies, hypersensitivity, or intolerance to any of the components (eg, excipients) of JNJ-78278343 or cetrelimab
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Significant infections or serious lung, heart or other medical conditions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Florida Cancer Specialists | Sarasota | Florida | United States | 34232 |
| 2 | Start Midwest | Grand Rapids | Michigan | United States | 49546 |
| 3 | Macquarie University | Macquarie University | Australia | 2109 | |
| 4 | Peter MacCallum Cancer Centre | Melbourne | Australia | 3000 | |
| 5 | Princess Alexandra Hospital | Woolloongabba | Australia | 4102 | |
| 6 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 7 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
| 8 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109321
- 2022-503132-14
- 78278343PCR1003