DCC-2812 in advanced kidney, bladder, and castration-resistant prostate cancers
Official title: An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer
Run by Deciphera Pharmaceuticals, LLC · NCT06966024 · Data updated 2026-11-12
This trial will test whether the oral drug DCC-2812 is safe and shows early signs of benefit for people with advanced kidney (renal cell), bladder (urothelial), or castration-resistant prostate cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Deciphera Pharmaceuticals, LLC Industry-sponsored |
| Locations | 8 sites (Boston, Massachusetts and 7 other locations) |
| Status | Recruiting |
| Started | August 27, 2025 |
| Main results expected | February 2029 |
| Study ends | February 2029 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT06966024 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with confirmed advanced or metastatic renal cell carcinoma, urothelial carcinoma, or castration-resistant prostate cancer who can take oral medication, have adequate organ function, and meet contraception requirements are the intended participants.
✕Probably not a fit
Patients who recently received other anticancer or investigational therapies, have impaired cardiac function, recent major surgery, or who cannot take oral medications are unlikely to be eligible or to receive benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter Phase 1, dose-escalation study of the selective GCN2 activator DCC-2812 given as monotherapy to patients with advanced or metastatic renal cell carcinoma, urothelial carcinoma, or castration-resistant prostate cancer. The trial focuses on characterizing safety, tolerability, pharmacokinetics, and any preliminary anti-tumor activity. Key eligibility features include the ability to take oral medication, adequate organ function, and no recent anticancer or investigational therapies or recent major surgery. Participants will be treated at specialized oncology centers with scheduled clinic visits for dosing, monitoring, and imaging.
Why it matters
Potential benefit: If successful, DCC-2812 could provide a new treatment option that targets a novel cellular stress pathway for patients with these advanced cancers.
How similar studies have gone: Activating the GCN2 pathway is a relatively novel approach with limited prior human data, so clinical benefit from this mechanism remains largely unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Have confirmed Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer * Able to take oral medication * If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements * Adequate organ function and electrolytes Key Exclusion Criteria: * Received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-2812 * Impaired cardiac function * Major surgery within 28 days of the first dose of study drug
Where it's running
-
Dana-Farber Cancer Institute
Boston, Massachusetts, United States Recruiting -
University of Michigan
Ann Arbor, Michigan, United States Recruiting -
Washington University School of Medicine
St Louis, Missouri, United States Recruiting -
Cleveland Clinic
Cleveland, Ohio, United States Recruiting -
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States Recruiting -
Vanderbilt- Ingram Cancer Center
Nashville, Tennessee, United States Recruiting
Show 2 more locations
-
NEXT Oncology, Austin
Austin, Texas, United States Recruiting -
NEXT Oncology, San Antonio
San Antonio, Texas, United States Recruiting
Study contacts
- Study coordinator: Clinical Team
- Email: clinicaltrials@deciphera.com
- Phone: 888-724-3274
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
First-in-human test of HH160 in people with advanced solid tumors
HH160 is being tested to see if it is safe and how it behaves in the body, to see if it has early signs of helping various advanced cancers in adults.
-
In-home cancer treatment with remote specialist support for patients in the Florida Panhandle
This program will try giving standard cancer treatments at home to people living in the Florida Panhandle and nearby areas to see if they prefer it and have better treatment satisfaction.
-
Investigating QXL138AM for patients with advanced solid tumors and multiple myeloma
This study is testing a new drug called QXL138AM to see if it can safely help people with advanced solid tumors and multiple myeloma.
-
Comparing home and clinic administration of nivolumab for cancer treatment
This study tests whether giving cancer patients their treatment at home instead of in a clinic makes them feel better and prefer their care more.
-
Combining local therapies with systemic treatment for certain cancers
This study is testing if adding local treatments like targeted radiation or ablation can help people with certain types of cancer, such as prostate or kidney cancer, stay on their main treatment longer without needing changes.
-
Testing NEO212 for treating certain brain tumors and metastases
This study is testing a new treatment called NEO212 for people with certain types of brain tumors to see if it is safe and effective when combined with standard treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.