Study of Docetaxel Combined with Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer
Key facts
- Who runs it
- University of California, San Diego
- Where
- La Jolla, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Phase 1
- People taking part
- 6 people enrolled
- Started
- 16 Jun 2022
- Ended
- 1 Oct 2024
- Type of study
- Interventional
- Treatments tested
- Cirmtuzumab
- Record updated
- 9 October 2024
- Why it stopped
- Oncternal closing clinical trial operations.
Who can take part
- Age
- 18 years and older
- Sex
- Men only
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate. Patients with neuroendocrine component are eligible
- Participants must have castrate levels of serum testosterone < 50 ng/dL
- Participants without orchiectomy must be maintained on luteinizing hormone releasing hormone (LHRH) agonist/antagonist
- 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
- Participants must have progressive disease. Patients with non-measurable disease are eligible
- Eastern Cooperative Oncology Group performance status ≤1 (Karnofsky ≥80%)
- Patients must have normal organ and marrow function
Who cannot take part
- Prior treatment with cirmtuzumab
- No prior treatment with docetaxel for CRPC
- 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
- Palliative radiation therapy to the bone or other sites within 2 weeks of treatment initiation
- Treatment with antimicrobial agent within 4 weeks of treatment initiation
- Uncontrolled intercurrent illness or clinically significant medical condition
- No pure small cell carcinoma
- Imminent or established spinal cord compression based on clinical and/or imaging findings
- Known active central nervous system metastases and/or carcinomatous meningitis
Where in United States
- University of California San DiegoLa Jolla, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Cirmtuzumab + DocetaxelTreatment being tested
There is only one treatment arm on this study. The combination of cirmtuzumab + docetaxel will be administered on one treatment arm. Treatment will cirmtuzumab will be administered initially as a loading dose alone on days 1, 15, and 29 of cycle 1. Following the loading, cirmtuzumab will be given on Day 1 of every 21-day cycle starting on Cycle 2 to up to Cycle 7 corresponding with concurrent docetaxel administration. Following discontinuation or completion of docetaxel, treatment with cirmtuzumab will be continued Day 1 of every 28 cycle until disease progression, toxicity or study withdrawal. Docetaxel will be administered on day 1 of every 21-day cycle starting Cycle 2 for up to 6 cycles.
Treatment: Cirmtuzumab
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase 1b Trial Investigating Docetaxel Combined with Cirmtuzumab in Patients with Metastatic Castration Resistant Prostate Cancer
- Record updated
- 9 October 2024