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
Summary Obj
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