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

NCT06785636 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: P-300-02-001
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 18

Brief 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).

Conditions

Male Urogenital Diseases; Prostate Cancer; mCRPC (Metastatic Castration-resistant Prostate Cancer); Genital Neoplasms, Male; Urogenital Neoplasms; Urogenital Cancers; Prostatic Diseases; Prostatic Neoplasms; Neoplasms; Neoplasms by Site

Keywords

mCRPC, metastatic castrate resistant prostate cancer, prostate cancer,; Procenbrodib; castration resistant

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicities (DLTs) and recommended Phase 2 dose (RP2D)

  DLT, serious adverse events (SAEs), clinically relevant adverse events (AEs), and clinically relevant safety laboratory values

  28-day

• RECIST v1.1 objective response rate (ORR)

  Proportion of participants with ORR. The response rate will be reported with an exact 95% CI.

  From date of enrollment until the date of first documented progression as per PCWG3 criteria, without ongoing clinical benefit or unacceptable toxicity or date of death from any cause, which came first, estimated to be 6 months.

• Prostate specific antigen (PSA)

  PSA decline post-treatment = ≥ 30% PSA50. The PSA will be reported with an exact 95% CI.

  From date of enrollment until the date of first documented progression as per PCWG3 criteria, without ongoing clinical benefit or unacceptable toxicity or date of death from any cause, which came first, estimated to be 6 months.

Secondary Outcomes (9)

• Maximum Plasma Concentration Observed (Cmax)

  At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first

• PSA30

  From date of enrollment until the date of first documented progression as per PCWG3 criteria, without ongoing clinical benefit or unacceptable toxicity or date of death from any cause, which came first, estimated to be 6 months.

• PSA50

  From date of enrollment until the date of first documented progression as per PCWG3 criteria, without ongoing clinical benefit or unacceptable toxicity or date of death from any cause, which came first, estimated to be 6 months.

• PSA90

  From date of enrollment until the date of first documented progression as per PCWG3 criteria, without ongoing clinical benefit or unacceptable toxicity or date of death from any cause, which came first, estimated to be 6 months.

• Progression Free Survival (PFS)

  From date of enrollment until the date of first documented progression as per PCWG3 criteria, without ongoing clinical benefit or unacceptable toxicity or date of death from any cause, which came first, estimated to be 6 months.

Study Arms (2)

Phase 1 Portion

EXPERIMENTAL

Dose level 1: 50 mg QD (5 days on/2 days off) Dose level 2: 100 mg QD (5 days on/2 days off) Dose level 3: 150 mg QD (5 days on/2 days off) Dose level 4: 200 mg QD (5 days on/2 days off) Dose level 5: 250 mg QD (5 days on/2 days off)

Drug: Pocenbrodib

Phase 2 portion

EXPERIMENTAL

Phase 2 involves Pocenbrodib monotherapy and in combination with abiraterone acetate, olaprib or 177Lu-PSMA0617

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

Interventions

Pocenbrodib DRUG

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

Phase 1 Portion; Phase 2 portion

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

Pocenbrodib alone or in combination

Phase 2 portion

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males with prostate issues
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pathos AI, Inc.: lead
• Duke University: collaborator

Study Sites (18)

MemorialCare Orange Coast Medical Center

Fountain Valley, California, 92708, United States

RECRUITING

Cancer and Blood Research Center

Los Alamitos, California, 90720, United States

RECRUITING

University of Colorado Health

Aurora, Colorado, 80045, United States

RECRUITING

Mount Sinai Medical Center

Miami, Florida, 33140, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Community Health Network

Indianapolis, Indiana, 46250, United States

RECRUITING

Ochsner

Jefferson, Louisiana, 70121, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Siteman Cancer Center

St Louis, Missouri, 63108, United States

RECRUITING

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

RECRUITING

Duke University medical center

Durham, North Carolina, 27710, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Taylor Cancer Research Center

Maumee, Ohio, 43537, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Oncology Consultants, P.A

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology - Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Genital Neoplasms, Male; Urogenital Neoplasms; Prostatic Diseases; Prostatic Neoplasms; Male Urogenital Diseases; Neoplasms; Neoplasms by Site

Interventions

Abiraterone Acetate; olaparib; Pluvicto

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Steve Kye, MD. MPH

CONTACT

708-232-3791; clinicaltrials@pathos.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1b/2a open-label dose finding study to assess safety, PK, efficacy, PD in patients with mCRPC.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: January 21, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 24, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)