Study of DCC-2812 in Participants With Advanced Genitourinary Cancers
Status
RECRUITING
Phase
PHASE1
Age
≥ 18 Years
Enrollments
60Conditions
Renal Cell Carcinoma, Urothelial Carcinoma, Castration-resistant Prostate CancerDrugs
DCC-2812Summary
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.
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Clinical Team
- 888-724-3274
- [email protected]
Study Director
- Clinical Team
Status
- RECRUITING
Central Contacts
- Clinical Team
- 888-724-3274
- [email protected]
Study Director
- Clinical Team
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 Plan
DCC-2812
EXPERIMENTAL
Participants will receive DCC-2812 in dose escalation manner per dosing regimen depending upon evolving pharmacokinetic (PK), pharmacodynamic, and safety data.
DRUG:
DCC-2812Description:
Administered orally
Outcome Measures
Primary Outcome Measures
Number of Participants with Dose-limiting Toxicities (DLTs)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs
Secondary Outcome Measures
Radiographic Objective Response Rate (rORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Radiographic Duration of Response (rDOR) per RECIST v1.1
PK: Maximum Observed Plasma Drug Concentration (Cmax)
PK: Time to Reach Cmax (Tmax)
PK: Area Under the Plasma Concentration-time Curve (AUC)
PK: Trough Plasma Concentration (Ctrough)
Timeline
Last Updated
November 19, 2025Start Date
May 11, 2025Today
December 19, 2025Completion Date ( Estimated )
February 1, 2029
Sponsors of this trial
Lead Sponsor
Deciphera Pharmaceuticals, LLC
RECRUITING 
18 - 80 Years