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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: 2026-02-11
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 (3)
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
NEXT Oncology, AustinRecruiting
Austin, Texas, United States
NEXT Oncology, San AntonioRecruiting
San Antonio, Texas, United States