Recruiting
Phase 1
Phase 2

Pocenbrodib, Abiraterone Acetate, Olaparib, 177Lu-PSMA-617

Sponsor:

Pathos AI, Inc.

Code:

NCT06785636

Conditions

mCRPC (Metastatic Castration-resistant Prostate Cancer)

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pocenbrodib

Pocenbrodib and Darolutamide

Study Details

Brief summary:

This is a dose-finding study to assess the safety and preliminary antitumor activity of Pocenbrodib alone or with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC)

Conditions

mCRPC (Metastatic Castration-resistant Prostate Cancer)

Prostate Cancer

Study ID

NCT06785636

Start date

Feb 7, 2025

Status verified date

Jun, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

1b / 2a 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

1b / 2a 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 Cycle 1 Day 1 or 5 half-lives (whichever is shorter).
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 complications.

2a only -key inclusion criteria:

1. Must have received at least 2 cycles of PLUVICTO®
2. 1 line of prior any ARPI therapy
3. No prior chemotherapy for mCRPC

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1b Arm 1

Pocenbrodib 50-250 mg QD (5 days on/2 days off)

experimental: Phase 1b Arm 2

Pocenbrodib 125-150 mg BID monotherapy

experimental: Phase 1b Arm 3

Pocenbrodib 125-150 mg BID + darolutamide 600 mg

experimental: Phase 2a portion

Cohort 1: pocenbrodib RP2D-high + darolutamide Cohort 2: pocenbrodib RP2D-low + darolutamide

Interventions

Pocenbrodib

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

Pocenbrodib and Darolutamide

Pocenbrodib in combination with darolutamide

Primary outcome measure

  • Phase 1b: Confirm the safety and tolerability of pocenbrodib and in combination with darolutamide [ Time Frame: 28 days ]
  • Phase 1b: Identify the recommended Phase 2 doses of pocenbrodib and in combination with darolutamide [ Time Frame: 28 days ]
  • Phase 2a: Assess the safety and tolerability of the RP2Ds of pocenbrodib in combination with darolutamide [ Time Frame: Through duration of treatment, estimated 6 months ]
  • Phase 2a: Evaluate the efficacy of RP2Ds of pocenbrodib in combination with darolutamide [ Time Frame: Through duration of treatment, estimated 6 months. ]

Central Contacts and Locations

Central contacts

Locations

MemorialCare Orange Coast Medical Center

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Principal Investigator:

Amol Rao, MD

Cancer and Blood Research Center

Recruiting

Los Alamitos, California, United States, 90720

Contacts

Principal Investigator:

Collin Vu, MD

University of Colorado Health

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Elaine Lam, MD

Mount Sinai Medical Center

Recruiting

Miami, Florida, United States, 33140

Contacts

Principal Investigator:

Bruno Bastos, MD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Jordan Ciuro

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Principal Investigator:

Mohammad Atiq

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

Office of Research Administration

317-621-3840ORA@ecommunity.com

Principal Investigator:

Natraj Ammakkanavar

Ochsner

Recruiting

Jefferson, Louisiana, United States, 70121

Contacts

Principal Investigator:

Brian Halbert

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

Adel Mandl

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Principal Investigator:

Frank Cackowski, MD

Siteman Cancer Center

Recruiting

St Louis, Missouri, United States, 63108

Contacts

Hannah Black

314-362-9913

Principal Investigator:

Melissa Reimers, MD

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Evan Roberts

531-329-3652

Principal Investigator:

Ralph Hauke, MD

Memorial Sloan-Kettering Cancer Center (Mskcc)

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

Nicholas Mai

Duke University medical center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Blayne Carney

9196608015

Principal Investigator:

Andrew Armstrong, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Lingbin Meng

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Principal Investigator:

John Nemunaitis

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Tian Zhang, MD

Oncology Consultants, P.A

Recruiting

Houston, Texas, United States, 77030

Contacts

Julio Peguero

(713) 600-0900

Principal Investigator:

Julio Peguero, MD

NEXT Oncology - Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Blake Patterson

703-783-4505

Principal Investigator:

Mohamad Salkeni, MD

More Information

Sponsor

Pathos AI, Inc.

Last update posted

Aug 20, 2026

Last verified

Jun, 2026

Keywords

  • mCRPC, metastatic castrate resistant prostate cancer, prostate cancer,
  • darolutamide
  • Pocenbrodib
  • p300-CBP Transcription Factors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pathos AI, Inc. on 2026-08-20.