Study of DCC-2812 in Participants With Advanced Genitourinary Cancers
Purpose
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.
Conditions
- Renal Cell Carcinoma
- Urothelial Carcinoma
- Castration-resistant Prostate Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental DCC-2812 |
Participants will receive DCC-2812 in dose escalation manner per dosing regimen depending upon evolving pharmacokinetic (PK), pharmacodynamic, and safety data. |
|
Recruiting Locations
Vanderbilt- Ingram Cancer Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- Deciphera Pharmaceuticals, LLC