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

Ki vehet részt

• 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

Ki nem vehet részt

• 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