A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Status: Recruiting

Location: See all (5) locations...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1

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

Participation Requirements

Sex: Male

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

United States

Colorado

University of Colorado Anschutz Medical Campus

RECRUITING

Aurora

New York

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

RECRUITING

New York

Texas

South Texas Accelerated Research Therapeutics, LLC (START)

RECRUITING

San Antonio

Other Locations

France

Centre Leon Berard

RECRUITING

Lyon

Institut Gustave Roussy

RECRUITING

Villejuif

Contact Information

Primary

Study Contact

Participate-In-This-Study1@its.jnj.com

844-434-4210

Time Frame

Start Date: 2023-11-01

Estimated Completion Date: 2027-10-27

Participants

Target number of participants: 250

Treatments

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). Participants will receive the combination treatment at the RP2R in Part 2 in different disease settings.

Related Therapeutic Areas

Prostate Cancer

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