for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion



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.

Official Title

A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors


Neoplasms JNJ-63898081


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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


  • University of California, San Francisco
    San Francisco California 94158 United States
  • University of Utah
    Salt Lake City Utah 84112 United States


in progress, not accepting new patients
Start Date
Completion Date
Janssen Research & Development, LLC
Phase 1
Study Type
Last Updated