Study of Docetaxel Combined With Cirmtuzumab in Metastatic Castration Resistant Prostate Cancer
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ClinicalTrials.gov Identifier: NCT05156905 |
Recruitment Status :
Recruiting
First Posted : December 14, 2021
Last Update Posted : November 13, 2023
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Castration-resistant Prostate Cancer | Drug: Cirmtuzumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1b Trial Investigating Docetaxel Combined With Cirmtuzumab in Patients With Metastatic Castration Resistant Prostate Cancer |
Actual Study Start Date : | June 16, 2022 |
Estimated Primary Completion Date : | February 2025 |
Estimated Study Completion Date : | February 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Cirmtuzumab + Docetaxel
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.
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Drug: Cirmtuzumab
Cirmtuzumab will be given in combination with docetaxel.
Other Name: Docetaxel |
- Recommended phase 2 dose of docetaxel combined with cirmtuzumab [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Defined by CTCAE version 5 grading
- Incidence of treatment-emergent adverse events [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Defined by CTCAE version 5 grading
- Total alkaline phosphatase response [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Defined as a reduction of ≥30% from the baseline value, confirmed ≥4 weeks later.
- Time to PSA progression [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Defined by PCWG-3 criteria
- Time to increase in the total alkaline phosphatase level [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Defined as an increase of ≥25% from baseline at ≥12 weeks, in patients with no decrease from baseline, or as an increase of ≥25% above the nadir, confirmed ≥3 weeks later, in patients with an initial decrease from baseline.
- Radiographic progression free survival [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Defined by PCWG-3 criteria for bone metastases and RECIST version 1.1 for soft tissue
- Time to first subsequent anti-cancer therapy [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Time from study discontinuation to initiation of subsequent systemic anti-cancer therapy or death
- Time to first symptomatic skeletal event [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Time to first symptomatic pathologic fracture, radiation to the bone given symptomatic bone metastasis, surgery to the bone given symptomatic bone metastasis, or symptomatic spinal cord compression
- Overall survival [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Time from enrollment to death or last follow up
- Composite clinical benefit [ Time Frame: Patients will be followed from study entry to death or date last known alive, assessed up to 36 months ]Composite endpoint of clinical benefit defined as any one of the following: PSA response by PCWG3 criteria, objective response rate by RECIST version 1.1, and stable disease > 6 months by RECIST version 1.1.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- No pure small cell carcinoma.
- 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.
- Imminent or established spinal cord compression based on clinical and/or imaging findings.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Uncontrolled intercurrent illness or clinically significant medical condition.
- Treatment with antimicrobial agent within 4 weeks of treatment initiation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05156905
Contact: Rana R McKay, MD | 858-822-6185 | rmckay@health.ucsd.edu |
United States, California | |
University of California San Diego | Recruiting |
La Jolla, California, United States, 92037 | |
Contact: Rana R McKay, MD 858-822-6185 rmckay@health.ucsd.edu |
Study Chair: | Rana McKay | UCSD |
Responsible Party: | Rana Mckay, Associate Professor of Medicine and Urology, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT05156905 |
Other Study ID Numbers: |
19-1514 |
First Posted: | December 14, 2021 Key Record Dates |
Last Update Posted: | November 13, 2023 |
Last Verified: | November 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Prostate cancer Docetaxel Wnt pathway Cirmtuzumab ROR1 |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases |
Prostatic Diseases Male Urogenital Diseases Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |