NCT06785636 A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
| NCT ID | NCT06785636 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Pathos AI, Inc. |
| Condition | mCRPC (Metastatic Castration-resistant Prostate Cancer) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2025-02-07 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06785636 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying mCRPC (Metastatic Castration-resistant Prostate Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06785636 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06785636 currently recruiting?
Yes, NCT06785636 is actively recruiting participants. Contact the research team at clinicaltrials@pathos.com for enrollment information.
Where is the NCT06785636 trial being conducted?
This trial is being conducted at Fountain Valley, United States, Los Alamitos, United States, Aurora, United States, Miami, United States and 11 additional locations.
Who is sponsoring the NCT06785636 clinical trial?
NCT06785636 is sponsored by Pathos AI, Inc.. The trial plans to enroll 120 participants.
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