Study of DCC-2812 in Participants With Advanced Genitourinary Cancers

NCT ID: NCT06966024

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-27

Study Completion Date

2029-02-28

Brief Summary

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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

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Conditions

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Renal Cell Carcinoma Urothelial Carcinoma Castration-resistant Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DCC-2812

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

Group Type EXPERIMENTAL

DCC-2812

Intervention Type DRUG

Administered orally

Interventions

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DCC-2812

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deciphera Pharmaceuticals, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Team

Role: STUDY_DIRECTOR

Deciphera Pharmaceuticals, LLC

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

NEXT Austin

Austin, Texas, United States

Site Status RECRUITING

NEXT Oncology

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Team

Role: CONTACT

888-724-3274

Other Identifiers

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DCC-2812-01-001

Identifier Type: -

Identifier Source: org_study_id

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