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Monoclonal Antibodies

Cirmtuzumab for Prostate Cancer

Phase 1

Recruiting

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%).

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recommended phase 2 dose of docetaxel combined with cirmtuzumab

Secondary outcome measures

Composite clinical benefit

Incidence of treatment-emergent adverse events

Overall survival

+6 more

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 / 4Eligibility criteria met

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Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,375 Total Patients Enrolled

7 Trials studying Prostate Cancer

1,270 Patients Enrolled for Prostate Cancer

Rana McKayStudy ChairUCSD

Media Library

Cirmtuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05156905 — Phase 1

Prostate Cancer Research Study Groups: Cirmtuzumab + Docetaxel

Prostate Cancer Clinical Trial 2023: Cirmtuzumab Highlights & Side Effects. Trial Name: NCT05156905 — Phase 1

Cirmtuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05156905 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elucidate the risks associated with Cirmtuzumab intake?

"Due to the limited evidence of Cirmtuzumab's safety and efficacy, our experts at Power gave it a 1 out of 3 rating."

Answered by AI

How many participants can the trial accommodate?

"Affirmative. Clinicaltrials.gov indicates that as of October 11th 2022, this research is still actively enrolling participants across one site and seeking 32 new patients since it was first established on June 16th 2022."

Answered by AI

What maladies can be effectively addressed with Cirmtuzumab?

"Cirmtuzumab is a common pharmacological choice for managing malignant neoplasms, as well as sarcoma, advanced directives and esophageal neoplasmic growths."

Answered by AI

Is there prior research that has touched upon Cirmtuzumab?

"At present, 320 clinical trials are investigating the efficacy of Cirmtuzumab. Of those active studies, 126 have advanced to Phase 3 and Fuzhou in Fujian is home to many of them. Across the world there is a total of 22389 sites running trials for this treatment."

Answered by AI

Is recruitment for this trial still active?

"As indicated on clinicaltrials.gov, the search for participants is still underway as of October 11th 2022 since this trial was first posted to the platform in June 16th 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Docetaxel Combined With Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer

Rana Mckay 2022. "Study of Docetaxel Combined With Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05156905.

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