Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Rana McKay (ucsd)
Headshot of Rana McKay
Rana McKay

Description

Summary

The purpose of this study is to examine the safety and efficacy of cirmtuzumab in combination with standard of care docetaxel in patients with metastatic castration resistant prostate cancer. Docetaxel is a taxane chemotherapy which has been shown to prolong survival in men with castration resistant prostate cancer. Cirmtuzumab is a monoclonal antibody that targets the receptor called ROR1 of the non-canonical Wnt pathway and is suspected to contribute to prostate cancer growth and progression.

Official Title

A Phase 1b Trial Investigating Docetaxel Combined With Cirmtuzumab in Patients With Metastatic Castration Resistant Prostate Cancer

Details

This study seeks to targeting the non-canonical Wnt pathway with an antibody against ROR1. ROR1 is an attractive target given its low expression in non-malignant tissues and its role in proliferation and survival in prostate cancer. From preclinical data in a variety of tumor types, blockade of ROR1 inhibits cell growth and cirmtuzumab has shown efficacy in clinical trials with CLL. Preclinical data suggests that ROR1 is upregulated in chemotherapy resistant cells and treatment with cirmtuzumab and a taxane achieved higher cytotoxic response than both agents alone, supporting the use of the combination of cirmtuzumab and a taxane. Based on the biological rationale behind cirmtuzumab and preclinical activity with docetaxel, this is an open label, phase 2 clinical trial to evaluate the safety and efficacy of cirmtuzumab in combination with docetaxel for the treatment of metastatic, castrate resistant prostate adenocarcinoma.

Keywords

Metastatic Castration-resistant Prostate Cancer Prostate cancer Docetaxel Wnt pathway Cirmtuzumab ROR1 Prostatic Neoplasms Cirmtuzumab + Docetaxel

Eligibility

You can join if…

Open to males ages 18 years and up

  1. Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate. Patients with neuroendocrine component are eligible.
  2. Participants must have castrate levels of serum testosterone < 50 ng/dL.
  3. Participants without orchiectomy must be maintained on luteinizing hormone releasing hormone (LHRH) agonist/antagonist.
  4. Participants must have received prior abiraterone and/or next generation androgen receptor antagonist (enzalutamide, apalutamide, or darolutamide) for hormone sensitive disease or CRPC. Prior docetaxel for hormone sensitive disease is permitted.
  5. Participants must have progressive disease. Patients with non-measurable disease are eligible.
  6. Eastern Cooperative Oncology Group performance status ≤1 (Karnofsky ≥80%).
  7. Patients must have normal organ and marrow function.

You CAN'T join if...

  1. No pure small cell carcinoma.
  2. Prior treatment with cirmtuzumab.
  3. No prior treatment with docetaxel for CRPC.
  4. Treatment with abiraterone, apalutamide, or darolutamide within 2 weeks of treatment initiation. Treatment with cytotoxic chemotherapy within 3 weeks of treatment initiation. Treatment enzalutamide or other investigational prostate cancer directed therapy within 4 weeks of treatment initiation.
  5. Palliative radiation therapy to the bone or other sites within 2 weeks of treatment initiation.
  6. Imminent or established spinal cord compression based on clinical and/or imaging findings.
  7. Known active central nervous system metastases and/or carcinomatous meningitis.
  8. Uncontrolled intercurrent illness or clinically significant medical condition.
  9. Treatment with antimicrobial agent within 4 weeks of treatment initiation.

Location

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States

Lead Scientist at UC Cancer

  • Rana McKay (ucsd)
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 182 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05156905
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 32 study participants
Last Updated