A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms

In brief

The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.

Key facts

Study ID

NCT03926013

Run by

Janssen Research & Development, LLC

People needed

40

Starts

2019-05-01

Expected to finish

2021-09-02

Last updated by the study team

2022-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histology: Part 1: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed. mCRPC is defined by prostate Cancer Working Group (PCWG )3 criteria. Part 2: mCRPC as defined above or pathologically confirmed metastatic renal cell carcinoma (RCC) as defined by world health organization (WHO) 2016 Classifications
• Measurable or evaluable disease: Part 1: Either measurable or evaluable disease for prostate cancer. Part 2: At least one measurable lesion as per RECIST v1.1.
• Evidence of disease progression on prior therapy that requires a new line of treatment
• Participants with accessible lesions enrolled in selected pharmacokinetic (PK)/pharmacodynamics (PD) cohorts and in Part 2 must agree to undergo the mandatory fresh tumor biopsies, unless collection of the biopsy presents a safety risk

You may not qualify if…

• Less than 2 weeks between prior anticancer treatment (including radiotherapy) discontinuation and the first dose of study drug, and toxicities have not returned to Grade less than or equal to (<=) 1 or baseline
• Prior treatment with prostate-specific membrane antigen (PSMA)-targeted therapy except for PSMA-targeted vaccine is permitted
• Solid organ or bone marrow transplantation
• Seizure or known condition that may predispose to seizure or intracranial masses
• Other active malignancy requiring systemic treatment <=12 months prior to enrollment

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• NIH Clinical Center — Bethesda, Maryland, United States
• Columbia University Medical Center — New York, New York, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Washington — Seattle, Washington, United States
• British Columbia Cancer Agency — Vancouver, British Columbia, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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