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Monoclonal Antibodies

Cirmtuzumab for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants without orchiectomy must be maintained on luteinizing hormone releasing hormone (LHRH) agonist/antagonist.

Eastern Cooperative Oncology Group performance status ≤1 (Karnofsky ≥80%).

Must not have

Prior treatment with cirmtuzumab.

Known active central nervous system metastases and/or carcinomatous meningitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will be followed from study entry to death or date last known alive, assessed up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if cirmtuzumab, a drug that targets a protein involved in cancer growth, can help treat men with metastatic prostate cancer that has resisted other treatments.

Who is the study for?

Men with metastatic castration-resistant prostate cancer who've had treatments like abiraterone or enzalutamide but not docetaxel for CRPC. They should be relatively healthy, have normal organ/marrow function, and testosterone levels under control. Those with small cell carcinoma or recent other treatments are excluded.

What is being tested?

The trial is testing the combination of cirmtuzumab (a monoclonal antibody targeting ROR1) with standard chemotherapy drug docetaxel to see if it's safe and works better for advanced prostate cancer than current treatments.

What are the potential side effects?

Possible side effects include those common to chemotherapy such as fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk; and those related to monoclonal antibodies like allergic reactions and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on hormone therapy to manage my cancer because I haven't had surgery to remove my testicles.

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I am fully active and can carry on all pre-disease activities without restriction.

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My testosterone levels are very low.

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My organs and bone marrow are functioning normally.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with cirmtuzumab before.

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My cancer has spread to my brain or its coverings.

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I do not have any uncontrolled illnesses or significant medical conditions.

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I haven't taken specific prostate cancer medications or chemotherapy recently.

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I have received radiation for symptom relief within the last 2 weeks.

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My spine is being compressed by my condition, confirmed by tests.

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My cancer is not purely small cell lung cancer.

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I have not taken antibiotics in the last 4 weeks.

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I have not been treated with docetaxel for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will be followed from study entry to death or date last known alive, assessed up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will be followed from study entry to death or date last known alive, assessed up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed from study entry to death or date last known alive, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recommended phase 2 dose of docetaxel combined with cirmtuzumab

Secondary study objectives

Composite clinical benefit

Incidence of treatment-emergent adverse events

Overall survival

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cirmtuzumab + DocetaxelExperimental Treatment1 Intervention

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.

0 / 13Eligibility criteria met