Prostatic Neoplasms
Conditions
Interventions
- Experimental: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)
Participants will receive JNJ-78278343+JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R)
Pasritamig
- Drug: JNJ-87189401
JNJ-87189401 will be administered.
Other Names: PSMAxCD28
Sponsors
Adachi Yayoi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - 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 - Part 1, Part 2A and Part 2B: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Part 1: Number of Participants With Dose Limiting Toxicity (DLT) DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. Time frame: Up to 21 days after first combination dose of study drugs 2. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity 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. Time frame: Up to 3 years 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Part 2: Serum Concentration of JNJ-87189401 Serum samples will be analyzed to determine concentrations of JNJ-87189401. Time frame: Up to 3 years 7 months 4. Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343 Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported. Time frame: Up to 3 years 7 months 5. Objective Response Rate (ORR) ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3). Time frame: Up to 3 years 7 months 6. Radiographic Progression-Free Survival (rPFS) rPFS is defined as time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first. Time frame: Up to 3 years 7 months 7. Prostate Specific Antigen (PSA) Response Rate PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline. Time frame: Up to 3 years 7 months 8. Duration of Response (DOR) according to response criteria of the Prostate Cancer Working Group 3 (PCWG3) 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. Time frame: Up to 3 years 7 months | — |
Countries
France, Japan, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed