Prostate Cancer Clinical Trial

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

Summary

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-69086420 in Part 1 (Dose Escalation) and to determine safety and and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologic: metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
Must have had prior exposure to at least one novel androgen receptor (AR) targeted therapy (example, abiraterone acetate, enzalutamide, apalutamide, darolutamide); prior taxane or other chemotherapy is acceptable but not required
Treatment with other agents for prostate cancer, if received, must have been discontinued greater than or equal to (>=) 2 weeks prior to first dose of study drug.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ functions as reflected in laboratory parameters

Exclusion Criteria:

Part 1: Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, or samarium therapy or radioconjugate therapy
Known history of myelodysplastic syndrome, leukemia, or hematological malignancy with features suggestive of myelodysplastic syndrome/acute myeloid leukemia at any timepoint
Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade less than or equal to <= 1 (except alopecia, radiation tissue fibrosis, or peripheral neuropathy)
Known allergies, hypersensitivity, or intolerance to JNJ-69086420 or its excipients and protein therapeutics
Active or chronic hepatitis B or hepatitis C infection.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT04644770

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 8 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
UCLA Medical Center
Los Angeles California, 90095, United States
University of California San Francisco
San Francisco California, 94158, United States
University of Chicago
Chicago Illinois, 60637, United States
Tulane School Of Medicine
New Orleans Louisiana, 70112, United States
Urology Cancer Center and GU Research Network
Omaha Nebraska, 68130, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Utah Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT04644770

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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