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

ConditionsmCRPC (Metastatic Castration-resistant Prostate Cancer)Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorPathos AI, Inc.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age

Histologic documentation of prostate adenocarcinoma

Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable

Disqualifiers

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 Cycle 1 Day 1 or 5 half-lives (whichever is shorter).

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Phase 1b Arm 1Experimental treatment 1 intervention
Group B: Phase 1b Arm 2Experimental treatment 1 intervention
Group C: Phase 1b Arm 3Experimental treatment 1 intervention
Group D: Phase 2a portionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
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

Time frame
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

Time frame
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.

Time frame
Through duration of treatment, estimated 6 months.

Secondary outcomes

1

Phase 1b: Plasma PK Cmax

Plasma PK parameter for Cmax

Time frame
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,

Time frame
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.

Time frame
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)

Time frame
Through duration of treatment, estimated 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pathos AI, Inc.

Lead sponsor

Duke University

Collaborator

Source ClinicalTrials.gov
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