Study of DCC-2812 in Participants With Advanced Genitourinary Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DCC-2812.
- Who it may be relevant to
- Registry conditions: Renal Cell Carcinoma, Urothelial Carcinoma, Castration-resistant Prostate Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer
Overview
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
- Drug DCC-2812
Administered orally
Primary outcome measures
- Number 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]
Secondary outcome measures (6)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Dana-Farber Cancer Institute — Boston
- University of Michigan — Ann Arbor
- Fox Chase Cancer Center — Philadelphia
- Vanderbilt- Ingram Cancer Center — Nashville
- NEXT Oncology, Austin — Austin
- NEXT Oncology, San Antonio — San Antonio
Identifiers
NCT: NCT06966024 · DCC-2812-01-001