Trial · NCT06785636
A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
NCT06785636, Phase 1, Phase 2, Recruiting, Pathos AI, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC. Trials, record NCT06785636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06785636
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
- NCT number
- NCT06785636
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Pathos AI, Inc.
- Conditions
- mCRPC (Metastatic Castration-resistant Prostate Cancer), Prostate Cancer
- Interventions
- Pocenbrodib, Pocenbrodib and Darolutamide
- First posted
- 2025-01-21
- Last updated
- 2026-08-20
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b: Confirm the safety and tolerability of pocenbrodib and in combination with darolutamide | 28 days | 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) |
| Primary | Phase 1b: Identify the recommended Phase 2 doses of pocenbrodib and in combination with darolutamide | 28 days | Frequency and type of DLTs used to determine the maximum tolerated dose (MTD) and RP2Ds |
| Primary | Phase 2a: Assess the safety and tolerability of the RP2Ds of pocenbrodib in combination with darolutamide | Through duration of treatment, estimated 6 months | 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 |
| Primary | Phase 2a: Evaluate the efficacy of RP2Ds of pocenbrodib in combination with darolutamide | Through duration of treatment, estimated 6 months. | 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. |
| Secondary | Phase 1b: Plasma PK Cmax | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first | Plasma PK parameter for Cmax |
| Secondary | Phase 1b: Plasma PK Tmax | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first | Plasma PK parameter for Tmax, |
| Secondary | Phase 1b: Plasma PK AUC for pocenbrodib | At the end of Cycle 1, 2, 3, and 4 (each cycle is 28 days) or until end of treatment, whichever came first. | Plasma PK AUC parameter for pocenbrodib. Pocenbrodib parameters compared to monotherapy Arms 1/2. |
| Secondary | Phase 1b: Model of cumulative exposure in relation to incidence of adverse events (AEs) | Through duration of treatment, estimated 6 months. | |
| Secondary | Phase 1b: Model of cumulative exposure in relation to incidence of serious adverse events (SAEs) | Through duration of treatment, estimated 6 months. | |
| Secondary | Phase 1b: Model of cumulative exposure in relation to incidence of adverse events of special interest (AESIs) | Through duration of treatment, estimated 6 months. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06785636
GET https://conductscience.org/api/trials/v1/NCT06785636/registered