Study of DCC-2812 in Participants With Advanced Genitourinary Cancers

Deciphera Pharmaceuticals, LLC

Status and phase: Enrolling; Phase 1

Conditions: Castration-resistant Prostate Cancer; Urothelial Carcinoma; Renal Cell Carcinoma

Treatments: Drug: DCC-2812

Study type: Interventional

Funder types: Industry

Identifiers

NCT06966024

DCC-2812-01-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

DCC-2812

Experimental group

Description:

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

Treatment:

Drug: DCC-2812