Prostate Cancer Clinical Trial
A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors
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.
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
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
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There are 7 Locations for this study
San Francisco California, 94158, United States
Bethesda Maryland, 20892, United States
New York New York, 10032, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98195, United States
Vancouver British Columbia, V5Z4E, Canada
Toronto Ontario, M5G 2, Canada
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