Clinical trial · Interventional
Study of DCC-2812 in Participants With Advanced Genitourinary Cancers
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
NCT06966024CI-TRIAL-00122541recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCC-2812 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DCC-2812
- description
- Participants will receive DCC-2812 in dose escalation manner per dosing regimen depending upon evolving pharmacokinetic (PK), pharmacodynamic, and safety data.
- interventionNames
- Drug: DCC-2812
Primary outcomes (3)
- measure
- Number of Participants with Dose-limiting Toxicities (DLTs)
- timeFrame
- Cycle 1 (28 days)
- measure
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- timeFrame
- Up to 42 months
- measure
- Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.