Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617
NCT ID: NCT06785636
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
252 participants
INTERVENTIONAL
2025-02-07
2029-04-30
Brief Summary
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Detailed Description
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The Phase 1b portion of the study involves pocenbrodib monotherapy at multiple, sequential five rising doses (50, 100, 150, 200, and 250mg) initially using a QD dosing schedule of 5 days on/2 days off. The first dose level (50 mg) will enroll at least 3 participants (with 3 more added if the first 3 participants yield 1 dose-limiting toxicity). Once safety is confirmed through Data Review Committee (DRC), the next higher pocenbrodib dose level cohort can begin enrollment.
If both acceptable safety and minimal threshold of efficacy (predefined as 30% PSA50 are achieved, the sponsor will proceed to Phase 2a.
Phase 2a will enroll participants in each of 4 cohorts: pocenbrodib monotherapy (2A), and 3 combination therapy cohorts: pocenbrodib + abiraterone acetate (2B), pocenbrodib + olaparib (2C), and pocenbrodib + 177Lu-PSMA-617 (2D). All cohorts may enroll in parallel, but each cohort will be evaluated independently for safety and efficacy.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1 Portion
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)
Pocenbrodib
Pocenbrodib is a selective oral inhibitor of CBP/p300 bromodomain interaction with acetylated lysines on histones.
Phase 2 portion
Phase 2 involves Pocenbrodib monotherapy and in combination with abiraterone acetate, olaprib or 177Lu-PSMA0617
Pocenbrodib
Pocenbrodib is a selective oral inhibitor of CBP/p300 bromodomain interaction with acetylated lysines on histones.
Cohort 2A (Pocenbrodib monotherapy), Cohort 2B (Pocenbrodib + abiraterone acetate), Cohort 2C (Pocenbrodib + olaparib), Cohort 2D (Pocenbrodib + 177Lu-PSMA-617
Pocenbrodib alone or in combination
Interventions
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Pocenbrodib
Pocenbrodib is a selective oral inhibitor of CBP/p300 bromodomain interaction with acetylated lysines on histones.
Cohort 2A (Pocenbrodib monotherapy), Cohort 2B (Pocenbrodib + abiraterone acetate), Cohort 2C (Pocenbrodib + olaparib), Cohort 2D (Pocenbrodib + 177Lu-PSMA-617
Pocenbrodib alone or in combination
Eligibility Criteria
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Inclusion Criteria
2. Histologic documentation of prostate adenocarcinoma
3. Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable
Exclusion Criteria
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)
18 Years
MALE
No
Sponsors
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Duke University
OTHER
Pathos AI, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Hannah Black
Role: primary
Evan Roberts
Role: primary
Blayne Carney
Role: primary
Julio Peguero
Role: primary
Blake Patterson
Role: primary
Other Identifiers
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P-300-02-001
Identifier Type: -
Identifier Source: org_study_id
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