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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
2025-020
NCT ID
NCT06785636
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I/II
Principal Investigator
Cackowski, Frank
Objective:
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)
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NCI Dictionary of Cancer Terms
KCI Clinical Trials App
Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
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
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
Get Directions
Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Other
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Hormonal Therapy, Radiopharmaceutical
Drugs
177Lu-PSMA-617; Abiraterone Acetate; Olaparib; Pocenbrodib
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