Metastatic Castration-resistant Prostate Cancer Clinical Trial
Official title:
A Phase 1b Trial Investigating Docetaxel Combined With Cirmtuzumab in Patients With Metastatic Castration Resistant Prostate Cancer
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | February 2026 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recommended phase 2 dose of docetaxel combined with cirmtuzumab | Defined by CTCAE version 5 grading | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months | |
Secondary | Incidence of treatment-emergent adverse events | Defined by CTCAE version 5 grading | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months | |
Secondary | Total alkaline phosphatase response | Defined as a reduction of =30% from the baseline value, confirmed =4 weeks later. | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months | |
Secondary | Time to PSA progression | Defined by PCWG-3 criteria | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months | |
Secondary | Time to increase in the total alkaline phosphatase level | 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. | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months | |
Secondary | Radiographic progression free survival | Defined by PCWG-3 criteria for bone metastases and RECIST version 1.1 for soft tissue | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months | |
Secondary | Time to first subsequent anti-cancer therapy | Time from study discontinuation to initiation of subsequent systemic anti-cancer therapy or death | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months | |
Secondary | Time to first symptomatic skeletal event | 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 | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months | |
Secondary | Overall survival | Time from enrollment to death or last follow up | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months | |
Secondary | Composite clinical benefit | 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. | Patients will be followed from study entry to death or date last known alive, assessed up to 36 months |
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