A Phase I Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
Study Identifier:
87189401PCR1001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
N/A
Study Contact Information:
Recruiting
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Study Summary
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.
To evaluate the safety, tolerability, and preliminary antitumor activity of JNJ-87189401 combined with JNJ-78278343 in mCRPC.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Male
Age
18+ years
Study Drug
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Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Drew Rasco
Status
Recruiting
Condition(s) Treated at Site
Prostate
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Bruno Fang
Status
Will Be Recruiting
Condition(s) Treated at Site
Prostate