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

  • STATUS
    Recruiting
  • End date
    Jul 7, 2023
  • participants needed
    50
  • sponsor
    Janssen Research & Development, LLC
Updated on 15 October 2021
cancer
chemotherapy regimen
adenocarcinoma
administration intravenous

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).

Details
Condition Malignant neoplasm of prostate, Adenocarcinoma, Prostatic disorder, Carcinoma, Vulvar Dysplasia and Carcinoma, Prostate Disorders, Prostate Cancer, Early, Recurrent, Advanced Malignancies, Prostate Cancer, Malignant Adenoma, prostate tumor, prostate tumors, adenocarcinomas
Treatment JNJ-69086420
Clinical Study IdentifierNCT04644770
SponsorJanssen Research & Development, LLC
Last Modified on15 October 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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