Prostatic Neoplasms

The purpose of this study is to evaluate how well JNJ-101556143 works in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR), an advanced form of prostate cancer that has spread and no longer responds to hormone therapy. The study will measure the overall response (tumor shrinkage or disappearance) following treatment with JNJ-101556143.

A Study of JNJ-101556143 in Participants With Metastatic Prostate Cancer

Castration-Resistant Prostatic Cancer

Prostatic Neoplasms, Castration-Resistant

Genitourinary Cancer

Advanced Solid Tumors

Prostate Neoplasms

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

JNJ-101556143

A Phase 2, Open-label, Multicenter, Single-arm Trial of JNJ-101556143, an Androgen Receptor-targeted Regulated Induced Proximity Targeting Chimera (RIPTAC™) Therapeutic in Participants With Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer

Confirmed overall response, is defined as having either confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) prior to any subsequent anti-cancer therapy.

DoR is defined as the time from the date of first documented response for a confirmed radiographic response (CR or PR) per RECIST v1.1 until the date of documented radiographic progression by BICR, or death, whichever comes first.

rPFS is defined as the time from the date of initiation of therapy until the date of radiographic disease progression or death, whichever comes first.

TSP is defined as the time from the first dose of trial intervention until the date of symptomatic progression or death, whichever comes first.

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale defined as Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.

Number of participants with abnormalities in clinical laboratory tests will be reported.

Minimum plasma concentration of JNJ-101556143 will be reported.

Maximum plasma concentration of JNJ-101556143 will be reported.

AUC0-24h is the area under the plasma concentration-time curve from the time of JNJ-101556143 dose administration up to 24-hour dosing interval.

Participants will receive JNJ-101556143 orally once daily in a 28-day treatment cycle until confirmed radiographic progression by blinded independent central review (BICR) or unequivocal clinical progression, or any other protocol-defined discontinuation criteria is met.

A Study of JNJ-101556143 in Participants With Metastatic Prostate Cancer

Trials at a glance

Trials at a glance

A Study of JNJ-101556143 in Participants With Metastatic Prostate Cancer

Outcome measures

Primary outcome measures

Secondary outcome measures