Castration-resistant Prostate Cancer, Renal Cell Carcinoma, Urothelial Carcinoma
Conditions
Keywords
Advanced malignancies
Brief summary
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.
Interventions
DRUGDCC-2812
Administered orally
Sponsors
Deciphera Pharmaceuticals, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Objective Response Rate (rORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 42 months |
| Radiographic Duration of Response (rDOR) per RECIST v1.1 | Up to 42 months |
| PK: Maximum Observed Plasma Drug Concentration (Cmax) | Predose up to 24 hours postdose (up to 42 months) |
| PK: Time to Reach Cmax (Tmax) | Predose up to 24 hours postdose (up to 42 months) |
| PK: Area Under the Plasma Concentration-time Curve (AUC) | Predose up to 24 hours postdose (up to 42 months) |
| PK: Trough Plasma Concentration (Ctrough) | Predose up to 24 hours postdose (up to 42 months) |
Countries
United States
Contacts
CONTACTClinical Team
STUDY_DIRECTORClinical Team
Deciphera Pharmaceuticals, LLC
Outcome results
None listed