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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Prostatic Neoplasms

Treatments: Drug: JNJ-80038114

Study type: Interventional

Funder types: Industry

Identifiers

NCT05441501

80038114PCR1001 (Other Identifier)

CR109209

Details and patient eligibility

About

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).

Enrollment: 39 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Part 1: Dose Escalation

Experimental group

Description:

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).

Treatment:

Drug: JNJ-80038114

Part 2: Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: JNJ-80038114