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

Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed adenocarcinoma ofthe 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 releasinghormone (LHRH) agonist/antagonist.

4. Participants must have received prior abiraterone and/or next generation androgenreceptor antagonist (enzalutamide, apalutamide, or darolutamide) for hormonesensitive disease or CRPC. Prior docetaxel for hormone sensitive disease ispermitted.

5. Participants must have progressive disease. Patients with non-measurable disease areeligible.

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 treatmentinitiation. Treatment with cytotoxic chemotherapy within 3 weeks of treatmentinitiation. Treatment enzalutamide or other investigational prostate cancer directedtherapy within 4 weeks of treatment initiation.

5. Palliative radiation therapy to the bone or other sites within 2 weeks of treatmentinitiation.

6. Imminent or established spinal cord compression based on clinical and/or imagingfindings.

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.