Clinical trial NCT06095089: A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer
Official title: A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Prostate Cancer
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
timeFrame: Up to 21 days after first combination dose of study drugs
measure: Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
timeFrame: 3 years 7 months
Secondary outcomes:
measure: Part 2: Serum Concentration of JNJ-87189401
timeFrame: Up to 3 years 7 months
measure: Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
timeFrame: Up to 3 years 7 months
measure: Objective Response Rate (ORR)
timeFrame: Up to 3 years 7 months
measure: Prostate Specific Antigen (PSA) Response Rate
timeFrame: Up to 3 years 7 months
measure: Duration of Response (DOR)
timeFrame: Up to 3 years 7 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: New York
country: United States
facility: Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
state: New York
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC (START)
state: Texas
city: Lyon
country: France
facility: Centre Leon Berard
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: