Study of DCC-2812 in Participants With Advanced Genitourinary Cancers

Phase 1

Not yet recruiting

• Conditions: Renal Cell Carcinoma; Urothelial Carcinoma; Castration-resistant Prostate Cancer
• Interventions: Drug: DCC-2812

• Registration Number: NCT06966024
• Lead Sponsor: Deciphera Pharmaceuticals, LLC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-02
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Study Start: 2025-08
• Primary Completion: 2029-02
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCC-2812	DCC-2812	Participants will receive DCC-2812 in dose escalation manner per dosing regimen depending upon evolving pharmacokinetic (PK), pharmacodynamic, and safety data.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Radiographic Objective Response Rate (rORR) per 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)