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
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Vanderbilt- Ingram Cancer Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
NEXT Oncology, Austin
Austin, Texas 78758
Austin, Texas 78758
NEXT Oncology, San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Deciphera Pharmaceuticals, LLC