Study on Pocenbrodib Alone and in Combination with Other Treatments for Advanced Prostate Cancer
Sponsor: Pathos AI, Inc.
ClinicalTrials ID:NCT06785636
This clinical trial is exploring the safety and initial effectiveness of a new drug, Pocenbrodib, used alone or with other treatments, in patients with advanced prostate cancer that has continued to grow despite previous therapies.
Patient Parameters
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Program Overview
The purpose of this study is to find out if Pocenbrodib, a new drug, is safe and can help reduce tumors in patients with advanced prostate cancer that has spread and is not responding to standard treatments. The study will test Pocenbrodib by itself and in combination with other drugs like Abiraterone acetate, Olaparib, or 177Lu-PSMA-617.
Description
This study is divided into two phases: Phase 1b and Phase 2a.
In Phase 1b, researchers will test different doses of Pocenbrodib to find the safest and most effective dose. Participants will take Pocenbrodib alone at increasing doses, starting from 50 mg up to 250 mg, following a schedule of 5 days on and 2 days off. The safety of each dose will be reviewed before moving to a higher dose.
If the drug is safe and shows signs of effectiveness, the study will move to Phase 2a. In this phase, participants will be divided into four groups: one group will receive Pocenbrodib alone, and the other three groups will receive Pocenbrodib combined with either Abiraterone acetate, Olaparib, or 177Lu-PSMA-617. Each group will be evaluated separately to see how safe and effective the treatments are.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of prostate adenocarcinoma.
- Have cancer that has spread to other parts of the body, confirmed by imaging tests done within 56 days before the study screening.
Exclusion Criteria
- Have any evidence of small cell or neuroendocrine cancer type in the most recent prostate biopsy.
- Have liver metastases confirmed by biopsy or imaging showing lesions larger than 1 cm in the liver.
- Have received chemotherapy, investigational drugs, or other cancer treatments, including enzalutamide, apalutamide, or darolutamide, within 14 days before the study screening.
- Have any serious medical, psychiatric, or other conditions that might interfere with participating in the study or increase the risk of complications from the treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Nebraska Cancer Specialists | 68130 | Omaha | Nebraska |
| Oncology Consultants | 77030 | Houston | Texas |
| NEXT Oncology - Virginia | 22031 | Fairfax | Virginia |
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