A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC
Recruiting · NCT06785636 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
PocenbrodibPocenbrodib and Darolutamide
What this trial is about
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 take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- b / 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.
- a 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
Where it is running
19 locations listed across 16 US states.
- MemorialCare Orange Coast Medical Center - Fountain Valley, California, United States
- Cancer and Blood Research Center - Los Alamitos, California, United States
- University of Colorado Health - Aurora, Colorado, United States
- Mount Sinai Medical Center - Miami, Florida, United States
- Emory University Hospital - Atlanta, Georgia, United States
- University of Chicago - Chicago, Illinois, United States
- Community Health Network - Indianapolis, Indiana, United States
- Ochsner - Jefferson, Louisiana, United States
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- Karmanos Cancer Institute - Detroit, Michigan, United States
- Siteman Cancer Center - St Louis, Missouri, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Memorial Sloan-Kettering Cancer Center (Mskcc) - New York, New York, United States
- Duke University medical center - Durham, North Carolina, United States
- The Ohio State University - Columbus, Ohio, United States
- Taylor Cancer Research Center - Maumee, Ohio, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- Oncology Consultants, P.A - Houston, Texas, United States
- NEXT Oncology - Virginia - Fairfax, Virginia, United States