A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Pathos AI, Inc.
Study ID
NCT06785636
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pocenbrodib — DRUG
    Pocenbrodib is a selective oral inhibitor of CBP/p300 bromodomain interaction with acetylated lysines on histones.
  • Pocenbrodib and Darolutamide — DRUG
    Pocenbrodib in combination with darolutamide

Study Details

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)

Key Dates

Start date
Feb 7, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Phase 1b: Confirm the safety and tolerability of pocenbrodib and in combination with darolutamide [ Time Frame: 28 days ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
MemorialCare Orange Coast Medical CenterFountain ValleyCalifornia92708
Alexis Wilson
[email protected]
562-972-8625
Amol Rao, MD (PRINCIPAL_INVESTIGATOR)
Cancer and Blood Research CenterLos AlamitosCalifornia90720
Collin Vu, MD
[email protected]
714-783-1838
Collin Vu, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado HealthAuroraColorado80045
Peyton Carter
[email protected]
303-724-9836
Elaine Lam, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai Medical CenterMiamiFlorida33140
Yvonne Enriquez
[email protected]
305-674-2625
Bruno Bastos, MD (PRINCIPAL_INVESTIGATOR)
Emory University HospitalAtlantaGeorgia30322
Wilena Session
[email protected]
404-778-3448
Jordan Ciuro (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Mohammad Atiq, MD
[email protected]
773-834-7002
Mohammad Atiq (PRINCIPAL_INVESTIGATOR)
Community Health NetworkIndianapolisIndiana46250
Office of Research Administration
[email protected]
317-621-3840
Natraj Ammakkanavar (PRINCIPAL_INVESTIGATOR)
OchsnerJeffersonLouisiana70121
Nikki Lassere
[email protected]
504- 703-0761
Brian Halbert (PRINCIPAL_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21287
Lynn Smith
[email protected]
410-502-8452
Adel Mandl (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Kimberlee Dobson
[email protected]
313-576-9837
Frank Cackowski, MD (PRINCIPAL_INVESTIGATOR)
Siteman Cancer CenterSt LouisMissouri63108
Hannah Black
314-362-9913
Melissa Reimers, MD (PRINCIPAL_INVESTIGATOR)
Nebraska Cancer SpecialistsOmahaNebraska68130
Evan Roberts
531-329-3652
Ralph Hauke, MD (PRINCIPAL_INVESTIGATOR)
Duke University medical centerDurhamNorth Carolina27710
Blayne Carney
9196608015
Andrew Armstrong, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Olivia Pardi
[email protected]
614-366-8309
Lingbin Meng (PRINCIPAL_INVESTIGATOR)
Taylor Cancer Research CenterMaumeeOhio43537
Stephanie Ambrose
[email protected]
567-402-4502
John Nemunaitis (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Tian Zhang
[email protected]
833-722-6237
Tian Zhang, MD (PRINCIPAL_INVESTIGATOR)
Oncology Consultants, P.AHoustonTexas77030
Julio Peguero
(713) 600-0900
Julio Peguero, MD (PRINCIPAL_INVESTIGATOR)
NEXT Oncology - VirginiaFairfaxVirginia22031
Blake Patterson
703-783-4505
Mohamad Salkeni, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fountain Valley, CA

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By research site
MemorialCare Orange Coast Medical Center· Fountain Valley, CACancer and Blood Research Center· Los Alamitos, CAUniversity of Colorado Health· Aurora, COMount Sinai Medical Center· Miami, FLEmory University Hospital· Atlanta, GAUniversity of Chicago· Chicago, IL

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