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Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617

RECRUITINGPhase 1/2Sponsored by Pathos AI, Inc.
Actively Recruiting
PhasePhase 1/2
SponsorPathos AI, Inc.
Started2025-02-07
Est. completion2028-06-30
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations10 sites

Summary

This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with Abiraterone acetate, Olaparib or 177Lu-PSMA-617 in patients with metastatic castration-resistant prostrate cancer (mCRPC).

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Key Inclusion Criteria:

1. ≥18 years of age
2. Histologic documentation of prostate adenocarcinoma
3. Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable

Key Exclusion Criteria:

1. Current or prior evidence of any small cell or neuroendocrine histology on the most recent prostate biopsy
2. Any liver metastases confirmed by biopsy or evidence of lesions \>1 cm consistent with liver metastases on imaging
3. Intervention with any chemotherapy, investigational agent, or other anticancer drug, including enzalutamide, apalutamide, or darolutamide, 14 days prior to Screening or 5 half-live20.
4. Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the Investigator may interfere with study participation and compliance or place the participant at high risk from treatment-related complicationss from the last dose (whichever is shorter)

Conditions11

CancerGenital Neoplasms, MaleMale Urogenital DiseasesNeoplasmsNeoplasms by SiteProstate CancerProstatic DiseasesProstatic NeoplasmsUrogenital CancersUrogenital Neoplasms

Locations10 sites

MemorialCare Orange Coast Medical Center
Fountain Valley, California, 92708
Alexis Wilson562-972-8625awilson4@memorialcare.org
University of Colorado Health
Aurora, Colorado, 80045
Peyton Carter303-724-9836PEYTON.CARTER@CUANSCHUTZ.EDU
Mount Sinai Medical Center
Miami, Florida, 33140
Yvonne Enriquez305-674-2625Yvonne.Enriquez@msmc.com
Karmanos Cancer Institute
Detroit, Michigan, 48201
Kimberlee Dobson313-576-9837dobsonk@karmanos.org
Siteman Cancer Center
St Louis, Missouri, 63108
Hannah Black314-362-9913

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