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mCRPC (Metastatic Castration-resistant Prostate Cancer)Phase 1/2P300NCT06785636

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

A Phase 1/2 study testing Pocenbrodib and Pocenbrodib and Darolutamide in people with mCRPC (Metastatic Castration-resistant Prostate Cancer) and Prostate Cancer, run by Pathos AI, Inc. at 19 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Pocenbrodib and Pocenbrodib and Darolutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
19 sitesUnited States
Study dates
7 Feb 2025to 30 Apr 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Steve Kye, MD, MPH contact

708-232-3791

clinicaltrials@pathos.com

19 sites in 1 country

United States19 sites, 19 recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Wilena Session, 404-778-3448, wsessio@emory.edu

    Jordan Ciuro

    Recruiting

  • University of Colorado Health

    Aurora, Colorado, 80045

    Peyton Carter, 303-724-9836, PEYTON.CARTER@CUANSCHUTZ.EDU

    Elaine Lam, MD

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Lynn Smith, 410-502-8452, lsmith36@jhmi.edu

    Adel Mandl

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Mohammad Atiq, MD, 773-834-7002, cancerclinicaltrials@bsd.uchicago.edu

    Mohammad Atiq

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Olivia Pardi, 614-366-8309, Olivia.Pardi@osumc.edu

    Lingbin Meng

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Tian Zhang, 833-722-6237, canceranswerline@utsouthwestern.edu

    Tian Zhang, MD

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Kimberlee Dobson, 313-576-9837, dobsonk@karmanos.org

    Frank Cackowski, MD

    Recruiting

  • Duke University medical center

    Durham, North Carolina, 27710

    Blayne Carney, 9196608015

    Andrew Armstrong, MD

    Recruiting

  • NEXT Oncology - Virginia

    Fairfax, Virginia, 22031

    Blake Patterson, 703-783-4505

    Mohamad Salkeni, MD

    Recruiting

  • MemorialCare Orange Coast Medical Center

    Fountain Valley, California, 92708

    Alexis Wilson, 562-972-8625, awilson4@memorialcare.org

    Amol Rao, MD

    Recruiting

  • Oncology Consultants, P.A

    Houston, Texas, 77030

    Julio Peguero, (713) 600-0900

    Julio Peguero, MD

    Recruiting

  • Community Health Network

    Indianapolis, Indiana, 46250

    Office of Research Administration, 317-621-3840, ORA@ecommunity.com

    Natraj Ammakkanavar

    Recruiting

  • Ochsner

    Jefferson, Louisiana, 70121

    Nikki Lassere, 504- 703-0761, Nikkia.lassere@ochsner.org

    Brian Halbert

    Recruiting

  • Cancer and Blood Research Center

    Los Alamitos, California, 90720

    Collin Vu, MD, 714-783-1838, cvu@cbsclinic.com

    Collin Vu, MD

    Recruiting

  • Taylor Cancer Research Center

    Maumee, Ohio, 43537

    Stephanie Ambrose, 567-402-4502, sambrose@tcrcpt.org

    John Nemunaitis

    Recruiting

  • Mount Sinai Medical Center

    Miami, Florida, 33140

    Yvonne Enriquez, 305-674-2625, Yvonne.Enriquez@msmc.com

    Bruno Bastos, MD

    Recruiting

  • Memorial Sloan-Kettering Cancer Center (Mskcc)

    New York, New York, 10065

    Nicholas Mai, 646-888-4322, main@mskcc.org

    Nicholas Mai

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Evan Roberts, 531-329-3652

    Ralph Hauke, MD

    Recruiting

  • Siteman Cancer Center

    St Louis, Missouri, 63108

    Hannah Black, 314-362-9913

    Melissa Reimers, MD

    Recruiting

Other trials in United States

About this study

Official title: PATHWAY: A Phase 1b/2a, Multicenter, Open- Label Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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)

Read the detailed description

This is a Phase 1b/2a multicenter, open-label study to confirm the safety, pharmacokinetics (PK), preliminary antitumor activity, and pharmacodynamics (PD) of pocenbrodib for the treatment of participants with mCRPC who have progressed following prior therapy and have been treated with at least 1 potent anti-androgen therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide).

Phase 1b is a dose escalation and optimization study of pocenbrodib monotherapy and in combination with darolutamide in order to determine the maximum tolerated dose (MTD) in participants (n=80) and to determine the recommended Phase 2 dose(s) (RP2D(s)).

Phase 1b consists of three arms: Arm 1 (50-250mg QD 5/2), Arm 2 (continuous monotherapy, 125mg-150mg BID), and Arm 3 (continuous combination of pocenbrodib 125-150mg BID + darolutamide 600mg BID), with DRC safety gates governing study progression between arms. Arm 3 is considered the safety run-in for the combination therapy.

Phase 2a is a dose expansion portion of the study to further evaluate the combination of pocenbrodib and darolutamide in participants with mCRPC who have progressed following lutetium-Lu-177-vipivotide-tetraxetan (PLUVICTO) and prior to initiation of taxane-based therapy and will consist of 2 cohorts:

Cohort 1: pocenbrodib RP2D high + darolutamide

Cohort 2: pocenbrodib RP2D low + darolutamide

Safety will be monitored by the DRC

Being tested
Pocenbrodib, Pocenbrodib and Darolutamide
Keywords
mCRPC, metastatic castrate resistant prostate cancer, prostate cancer,, darolutamide, Pocenbrodib, p300-CBP Transcription Factors
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PocenbrodibDrug

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

  • Pocenbrodib and DarolutamideDrug

    Pocenbrodib in combination with darolutamide

Study groups in NCT06785636
Study groupRoleWhat they receive
Phase 1b Arm 1ExperimentalPocenbrodib 50-250 mg QD (5 days on/2 days off)
Receives: Drug: Pocenbrodib
Phase 1b Arm 2ExperimentalPocenbrodib 125-150 mg BID monotherapy
Receives: Drug: Pocenbrodib
Phase 1b Arm 3ExperimentalPocenbrodib 125-150 mg BID + darolutamide 600 mg
Receives: Drug: Pocenbrodib and Darolutamide
Phase 2a portionExperimentalCohort 1: pocenbrodib RP2D-high + darolutamide Cohort 2: pocenbrodib RP2D-low + darolutamide
Receives: Drug: Pocenbrodib and Darolutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: Confirm the safety and tolerability of pocenbrodib and in combination with darolutamide

    Occurrence and severity of Serious Adverse Events (SAEs) and clinically relevant Adverse Events (AEs), and clinically significant changes in safety laboratory values and electrocardiograms (ECGs)

    Measured: 28 days

  2. Phase 1b: Identify the recommended Phase 2 doses of pocenbrodib and in combination with darolutamide

    Frequency and type of DLTs used to determine the maximum tolerated dose (MTD) and RP2Ds

    Measured: 28 days

  3. Phase 2a: Assess the safety and tolerability of the RP2Ds of pocenbrodib in combination with darolutamide

    1. Occurrence and severity of SAEs, clinically relevant AEs, and clinically significant changes in safety laboratory values, physical examination (PE) findings, vital signs, and ECGs.
    2. Safety and selection of pocenbrodib RP2D for combination with darolutamide for subsequent development

    Measured: Through duration of treatment, estimated 6 months

  4. Phase 2a: Evaluate the efficacy of RP2Ds of pocenbrodib in combination with darolutamide

    Post-177Lu-PSMA-617 (Post-PLUVICTO®) pre-taxane mCRPC: Radiographic progression-free survival (rPFS), assessed as time from randomization to first occurrence of Radiographic progression-free survival (rPFS) according to; i) Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and ii) Prostate Cancer Working Group 3 (PCWG3) criteria or death from any cause, whichever comes first.

    Measured: Through duration of treatment, estimated 6 months.

Secondary outcomes (13)

  1. Phase 1b: Plasma PK Cmax

    Plasma PK parameter for Cmax

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

  2. Phase 1b: Plasma PK Tmax

    Plasma PK parameter for Tmax,

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

  3. Phase 1b: Plasma PK AUC for pocenbrodib

    Plasma PK AUC parameter for pocenbrodib. Pocenbrodib parameters compared to monotherapy Arms 1/2.

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

  4. Phase 1b: Model of cumulative exposure in relation to incidence of adverse events (AEs)

    Measured: Through duration of treatment, estimated 6 months.

  5. Phase 1b: Model of cumulative exposure in relation to incidence of serious adverse events (SAEs)

    Measured: Through duration of treatment, estimated 6 months.

  6. Phase 1b: Model of cumulative exposure in relation to incidence of adverse events of special interest (AESIs)

    Measured: Through duration of treatment, estimated 6 months.

  7. Phase 2a: Characterize the PK of pocenbrodib in combination with darolutamide

    Characterize the PK of pocenbrodib in combination with darolutamide in participants with mCRPC after progressing after 177Lu-PSMA-617 (PLUVICTO®) treatment

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

  8. Phase 2a: Plasma PK Cmax pocenbrodib/darolutamide

    Plasma PK parameter for Cmax for pocenbrodib and darolutamide combined

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

  9. Phase 2a: Plasma PK Tmax pocenbrodib/darolutamide

    Plasma PK parameter for Tmax for pocenbrodib and darolutamide combined

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

  10. Phase 2a: Plasma PK AUC0-24 pocenbrodib/darolutamide

    Plasma PK parameter for AUC0-24 for pocenbrodib and darolutamide combined

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

  11. Phase 2a: rPFS (radiographic Progression Free Survival)

    Evaluate efficacy parameters based on RECIST v1.1 and PCWG3 criteria for rPFS (radiographic Progression Free Survival)

    Measured: Through duration of treatment, estimated 6 months

  12. Phase 2a: Prostate Specific Antigen (PSA) 50% (PSA50) change from baseline.

    Evaluate efficacy parameters based on RECIST v1.1 and PCWG3 criteria for Prostate Specific Antigen (PSA) 50% (PSA50) change from baseline

    Measured: Through duration of treatment, estimated 6 months

  13. Phase 2a: Prostate Specific Antigen PSA 90% (PSA90) change from baseline.

    Evaluate efficacy parameters based on RECIST v1.1 and PCWG3 criteria for Prostate Specific Antigen PSA 90% (PSA90) change from baseline

    Measured: Through duration of treatment, estimated 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2025
  2. Study start7 Feb 2025
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase 1b/2a open-label dose finding study to assess safety, PK, efficacy, PD in patients with mCRPC.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06785636
Sponsor's protocol ID
P-300-02-001
Acronym
P300
Status last verified
Jun 2026
First submitted
10 Dec 2024
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pathos AI, Inc. will determine once safety and preliminary efficacy is defined.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pocenbrodib and Pocenbrodib and Darolutamide in people with mCRPC (Metastatic Castration-resistant Prostate Cancer) and Prostate Cancer, run by Pathos AI, Inc. at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Steve Kye, MD, MPH (708-232-3791, clinicaltrials@pathos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Confirm the safety and tolerability of pocenbrodib and in combination with darolutamide (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06785636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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