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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2024-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Dose Escalation

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).

Group Type EXPERIMENTAL

JNJ-80038114

Intervention Type DRUG

JNJ-80038114 will be administered.

Part 2: Dose Expansion

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

Group Type EXPERIMENTAL

JNJ-80038114

Intervention Type DRUG

JNJ-80038114 will be administered.

Interventions

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JNJ-80038114

JNJ-80038114 will be administered.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No