Prostatic Neoplasms
Conditions
Brief summary
The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.
Interventions
DRUGJNJ-78278343
JNJ-78278343 will be administered.
DRUGJNJ-87189401
JNJ-87189401 will be administered.
DRUGApalutamide
Apalutamide will be administered.
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
DRUGJNJ-101556143
JNJ-101556143 will be administered.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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, Parts 2A, 2B, 3 and 4: 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
* History of an autoimmune disease within the 12 months prior to signing consent * 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 | Description |
|---|---|---|
| Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) | Up to 21 days after first combination dose of study drugs | DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. |
| Number of Participants with Adverse Events (AEs) by Severity | Up to 4 years 8 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
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentrations of JNJ-87189401 and JNJ-78278343 | Up to 4 years 8 months | Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343. |
| Plasma Concentration of JNJ-101556143 | Up to 4 years 8 months | Plasma samples will be analyzed to determine concentrations of JNJ-101556143. |
| Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343 | Up to 4 years 8 months | Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported. |
| Objective Response Rate (ORR) | Up to 4 years 8 months | 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 Clinical Trials Working Group 3 (PCWG3). |
| Radiographic Progression-Free Survival (rPFS) | Up to 4 years 8 months | rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first. |
| Prostate Specific Antigen (PSA) Response Rate | Up to 4 years 8 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 4 years 8 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. |
Countries
France, Japan, United States
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed