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
Primary Investigator
Vaishampayan, Ulka
Status
OPEN TO ACCRUAL
Phase
I
NCT Number
NCT06966024
UM Number
2025.094
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Genitourinary Oncology
ID (Protocol)
60787
Secondary Protocol No
HUM00278787
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Kidney
Other Urinary
Prostate
Urinary Bladder
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.
Eligibility: Inclusion Criteria
• Key
• * 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
For more information about a trial or help finding one, contact the Cancer AnswerLine at 800-865-1125 or [email protected]