Summary

for people ages 18 years and up (full criteria)
at UCSF
study started
estimated completion

Description

Summary

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

Keywords

Neoplasms JNJ-63898081

Eligibility

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...

  • At least 2 weeks between prior anticancer treatment (including radiotherapy) discontinuation and the first dose of study drug, and toxicities have 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

Locations

  • University of California, San Francisco not yet accepting patients
    San Francisco California 94158 United States
  • University of Utah completed
    Salt Lake City Utah 84112 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT03926013
Phase
Phase 1
Study Type
Interventional
Last Updated