A Phase 1b/2a, Multicenter, Open-Label Study of Pocenbrodib as Monotherapy and in Combination with Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617 in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

Phase 1b:

Confirm the safety and tolerability of pocenbrodib monotherapy in men with mCRPC
Determine the RP2D of pocenbrodib as monotherapy in men with mCRPC

Phase 2a:

Evaluate the clinical activity of pocenbrodib in men with mCRPC as monotherapy and in combination with abiraterone acetate, olaparib, or lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617)

Secondary objectives:

Phase 1b and Phase 2a:

Characterize the PK of pocenbrodib in men with mCRPC
Evaluate the relationship between exposure to pocenbrodib and effect (response, safety, and/or resistance)

Eligibility

Inclusion Criteria:

≥18 years of age
Histologic documentation of prostate adenocarcinoma
Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable

Exclusion Criteria:

Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy
Any liver metastases confirmed by biopsy or evidence of lesions >1 cm consistent with liver metastases on imaging
Intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to Screening or 5 half-live20.

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices