A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer

NCT05441501 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10920980038114PCR1001
• Study Type: interventional
• Target: 39
• Locations: 2 countries
• Sites: 6

Brief Summary

The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).

Conditions

Prostatic Neoplasms

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (3)

• Parts 1 and 2: Number of Participants With Adverse Events (AEs)

  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.

  Up to 2 Years 6 Months

• Parts 1 and 2: Number of Participants With AEs by Severity

  Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. 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. Cytokine release syndrome (CRS) and associated neurologic toxicity events will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.

  Up to 2 Years 6 Months

• Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)

  Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

  Up to 2 Years 6 Months

Secondary Outcomes (7)

• Serum Concentration of JNJ-80038114

  Up to 2 Years 6 Months

• Systemic Cytokine Concentrations

  Up to 2 Years 6 Months

• Serum Prostate Specific Antigen (PSA) Concentration

  Up to 2 Years 6 Months

• Number of Participants With Antibodies to JNJ-80038114

  Up to 2 Years 6 Months

• Objective Response Rate (ORR)

  Up to 2 Years 6 Months

Study Arms (2)

Part 1: Dose Escalation

EXPERIMENTAL

Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET).

Drug: JNJ-80038114

Part 2: Dose Expansion

EXPERIMENTAL

Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1.

Drug: JNJ-80038114

Interventions

JNJ-80038114 DRUG

JNJ-80038114 will be administered.

Part 1: Dose Escalation; Part 2: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
• Measurable or evaluable disease
• At least 1 prior treatment for mCRPC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ functions as defined by certain laboratory values
• Must sign an informed consent form (ICF)
• Participants must agree to use a highly effective form of birth control as guided by the study doctor

You may not qualify if:

• Concurrent anticancer therapy
• Severe or long-lasting side effects related to prior anticancer therapy
• Known allergies to JNJ-80038114 or its excipients
• Brain metastasis or known seizure history
• Significant infections or lung, heart or other medical conditions

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (6)

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Sidney Kimmel Cancer Center - Jefferson Health

Philadelphia, Pennsylvania, 19107, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University College London Hospitals NHSFT

London, NW1 2PG, United Kingdom

Location

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• Hudson A, Jayaram A, Garmezy B, Zorko NA, Zarrabi KK, Mathews L, Rupnow B, Li M, Ghosh D, Urtishak K, Francis P, Wang SC, Attiyeh E, de Bono J. A phase 1, first-in-human, dose escalation study of JNJ-80038114, a PSMAxCD3 bispecific antibody, in participants with metastatic castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2026 Jan 6;96(1):5. doi: 10.1007/s00280-025-04846-w.

  PMID: 41493473 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: November 15, 2022
• Primary Completion: March 26, 2024
• Study Completion: March 31, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (3); US (3)