DCC-2812 in advanced kidney, bladder, and castration-resistant prostate cancers
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
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Deciphera Pharmaceuticals, LLC Industry-sponsored |
| Locations | 4 sites (Boston, Massachusetts and 3 other locations) |
| Trial ID | NCT06966024 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Activating the GCN2 pathway is a relatively novel approach with limited prior human data, so clinical benefit from this mechanism remains largely unproven.
Eligibility criteria
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 this trial is running
Boston, Massachusetts and 3 other locations
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Vanderbilt- Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.