RecruitingRecruiting
Study of DCC-2812 in Participants With Advanced Genitourinary Cancers
NCT06966024 · Deciphera Pharmaceuticals, LLC
In plain English
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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
About this study
This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced/metastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.
Eligibility 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
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-08-27
Estimated completion: 2029-02
Last updated: 2026-08-18
Interventions
Drug: DCC-2812
Primary outcomes
- • Number of Participants with Dose-limiting Toxicities (DLTs) (Cycle 1 (28 days))
- • Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Up to 42 months)
- • Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs (Up to 42 months)
Sponsor
Deciphera Pharmaceuticals, LLC · industry
Contacts & investigators
ContactClinical Team · contact · clinicaltrials@deciphera.com · 888-724-3274
InvestigatorClinical Team · study_director, Deciphera Pharmaceuticals, LLC
All locations (8)
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Vanderbilt- Ingram Cancer CenterRecruiting
Nashville, Tennessee, United States
NEXT Oncology, AustinRecruiting
Austin, Texas, United States
NEXT Oncology, San AntonioRecruiting
San Antonio, Texas, United States