No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Pathos AI, Inc. · Industry
Who this trial is looking for
This trial is looking for men with advanced prostate cancer that has not responded to hormone treatment. Participants will take the drug Pocenbrodib alone or with another treatment called darolutamide to see how safe it is and how well it works.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with prostate adenocarcinoma.
I have metastatic cancer confirmed by imaging within the last 56 days.
You may not be able to join if
I have had small cell or neuroendocrine cancer in my prostate biopsy.
I have liver metastases confirmed by biopsy or significant lesions on imaging.
I received chemotherapy or certain cancer treatments in the last 14 days.
I have any serious medical or mental health issues that could interfere with the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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)
Trial Locations
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City
State
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Status
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 neur…
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
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