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New treatment option for mCRPC (Metastatic Castration-resistant Prostate Cancer)
Official title A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
ClinicalTrials.gov ID: NCT06785636
What this study is testing
What is Pocenbrodib?
Pocenbrodib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mcrpc (metastatic castration-resistant prostate cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 1b / 2a
- ≥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
You likely can't join if
- 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...
- Any other serious underlying medical, psychiatric, psychological, familial, or geographical condition, which in the judgment of the Investigator may...
- Must have received at least 2 cycles of PLUVICTO®
- 1 line of prior any ARPI therapy
See the full eligibility criteria
- 1b / 2a
- ≥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
- 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...
- Must have received at least 2 cycles of PLUVICTO®
- 1 line of prior any ARPI therapy
- No prior chemotherapy for mCRPC
The study team makes the final eligibility decision.
Where it's taking place
- Fountain Valley, California, United States
- Los Alamitos, California, United States
- Aurora, Colorado, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Jefferson, Louisiana, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Maumee, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fountain Valley, California, United States; Los Alamitos, California, United States; Aurora, Colorado, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.