A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer

Advanced Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095089
• Other study ID #: CR109330
• Secondary ID: 87189401PCR10012
• Status: Recruiting
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: June 21, 2027

Study information

• Verified date: April 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 21, 2027
• Est. primary completion date: June 21, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• JNJ-78278343
JNJ-78278343 will be administered.
• JNJ-87189401
JNJ-87189401 will be administered.

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon
France	Institut Gustave Roussy	Villejuif
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center	New York	New York
United States	South Texas Accelerated Research Therapeutics, LLC (START)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 21 days after first combination dose of study drugs
Primary	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.	3 years 7 months
Secondary	Part 2: Serum Concentration of JNJ-87189401	Serum samples will be analyzed to determine concentrations of JNJ-87189401.	Up to 3 years 7 months
Secondary	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.	Up to 3 years 7 months
Secondary	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).	Up to 3 years 7 months
Secondary	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.	Up to 3 years 7 months
Secondary	Duration of Response (DOR)	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.	Up to 3 years 7 months