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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Administered orally
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGNEXT Oncology, Austin
Austin, Texas, United States
RECRUITINGNEXT Oncology, San Antonio
San Antonio, Texas, United States
RECRUITINGNumber of Participants with Dose-limiting Toxicities (DLTs)
Time frame: Cycle 1 (28 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 42 months
Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs
Time frame: Up to 42 months
Radiographic Objective Response Rate (rORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to 42 months
Radiographic Duration of Response (rDOR) per RECIST v1.1
Time frame: Up to 42 months
PK: Maximum Observed Plasma Drug Concentration (Cmax)
Time frame: Predose up to 24 hours postdose (up to 42 months)
PK: Time to Reach Cmax (Tmax)
Time frame: Predose up to 24 hours postdose (up to 42 months)
PK: Area Under the Plasma Concentration-time Curve (AUC)
Time frame: Predose up to 24 hours postdose (up to 42 months)
PK: Trough Plasma Concentration (Ctrough)
Time frame: Predose up to 24 hours postdose (up to 42 months)
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