Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Duarte, California and other locations
Dates
study started
completion around
Principal Investigator
by Jeremie Calais
Headshot of Jeremie Calais
Jeremie Calais

Description

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 preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion).

Official Title

A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

Keywords

Prostatic Neoplasms, Adenocarcinoma, JNJ-69086420

Eligibility

You can join if…

Open to males ages 18 years and up

  • Metastatic castration resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma (adenocarcinoma with small-cell or neuroendocrine features is allowed) with prior exposure to at least one androgen receptor (AR) targeted therapy (example, abiraterone acetate, enzalutamide, apalutamide, darolutamide). In addition:

    Part 1: prior taxane or other chemotherapy is acceptable but not required. Part 2a: prior taxane or other chemotherapy required, Part 2b: no prior taxane or other chemotherapy, Part 2c: mCRPC that has progressed after prior treatment with lutetium Lu-177 vipivotide tetraxetan

  • Prior orchiectomy or medical castration; or, for participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist) prior to the first dose of study drug and must continue this therapy throughout the treatment phase
  • Palliative radiotherapy (for example [eg], soft tissue lesions) must be completed greater than (>) 2 weeks prior to start of study drug except for palliative radiotherapy for pain (eg, bone pain), which may be used any time prior to first dose
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ functions as reflected in laboratory parameters

You CAN'T join if...

  • Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, samarium, or other radioconjugate therapy. In addition: Part 2b: Prior treatment with chemotherapy (eg, docetaxel) or poly ADP ribose polymerase (PARP) inhibitors. Part 2c: Prior treatment with lutetium Lu-177 vipivotide tetraxetan is permitted
  • 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

Locations

  • City of Hope accepting new patients
    Duarte California 91010 United States
  • University of Utah Huntsman Cancer Institute accepting new patients
    Salt Lake City Utah 84112 United States

Lead Scientist at UCLA

  • Jeremie Calais
    Nuclear medicine physician specialized in cancer imaging and theranostics. Associate Professor, Department of Molecular and Medical Pharmacology at UCLA Director, Theranostics Program, Ahmanson Translational Theranostics Division at UCLA Faculty Member of the Jonsson Comprehensive Cancer Center at UCLA. Faculty Member of the Institute of Urologic Oncology at UCLA.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT04644770
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 111 study participants
Last Updated