A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
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)
About This Trial
- This study is testing an experimental drug called pocenbrodib, taken either alone or with a standard prostate cancer medicine, to find safe doses and see if it can help shrink or slow tumors.
- It is designed for adults with advanced prostate cancer that has spread to other parts of the body and no longer responds to standard hormone-lowering treatments.
- Before considering this trial, you should know that you cannot join if your cancer has spread to your liver or if you have received chemotherapy for your advanced cancer.
- Depending on which group of the study you enter, you may also need to have tried specific treatments in the past, such as Pluvicto, and you must pause other cancer drugs before starting.
More Information
- 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)
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing an experimental drug called pocenbrodib, taken either alone or with a standard prostate cancer medicine, to find safe doses and see if it can help shrink or slow tumors.
Study Details
- Start Date: February 7, 2025
- Lead Sponsor: Pathos AI, Inc.
Full Eligibility Criteria
1b / 2a Inclusion Criteria:
- ≥18 years of age
- Histologic documentation of prostate adenocarcinoma
- Metastatic disease, documented by imaging. Imaging performed within 56 days prior to Screening is acceptable 1b / 2a Exclusion Criteria:
- 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. 2a only -key inclusion criteria:
- Must have received at least 2 cycles of PLUVICTO®
- 1 line of prior any ARPI therapy
- No prior chemotherapy for mCRPC
Treatments
- Drug: Pocenbrodib
- Drug: Pocenbrodib and Darolutamide