RecruitingPhase 1Phase 2NCT06785636

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

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


Sponsor

Pathos AI, Inc.

Enrollment

252 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria3

  • ≥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 Criteria4

  • 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.
  • 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)

Interventions

DRUGPocenbrodib

Pocenbrodib is a selective oral inhibitor of CBP/p300 bromodomain interaction with acetylated lysines on histones.

DRUGCohort 2A (Pocenbrodib monotherapy), Cohort 2B (Pocenbrodib + abiraterone acetate), Cohort 2C (Pocenbrodib + olaparib), Cohort 2D (Pocenbrodib + 177Lu-PSMA-617

Pocenbrodib alone or in combination


Locations(10)

MemorialCare Orange Coast Medical Center

Fountain Valley, California, United States

University of Colorado Health

Aurora, Colorado, United States

Mount Sinai Medical Center

Miami, Florida, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Siteman Cancer Center

St Louis, Missouri, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Duke University medical center

Durham, North Carolina, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Oncology Consultants, P.A

Houston, Texas, United States

NEXT Oncology - Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06785636


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