Recruiting
Phase 1

DCC-2812

Sponsor:

Deciphera Pharmaceuticals, LLC

Code:

NCT06966024

Conditions

Renal Cell Carcinoma

Urothelial Carcinoma

Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DCC-2812

Study Details

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.

Conditions

Renal Cell Carcinoma

Urothelial Carcinoma

Castration-resistant Prostate Cancer

Study ID

NCT06966024

Start date

Aug 27, 2025

Status verified date

Aug, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: DCC-2812

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

Interventions

DCC-2812

Administered orally

Primary outcome measure

  • Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (28 days) ]
  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 42 months ]
  • Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs [ Time Frame: Up to 42 months ]

Central Contacts and Locations

Central contacts

Clinical Team

888-724-3274clinicaltrials@deciphera.com

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Bicky Thapa, MD

617-632-3000bicky_thapa@dfci.harvard.edu

Principal Investigator:

Bicky Thapa, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Ulka Vaishampayan, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Hannah Black

314-362-9913hannahblack@wustl.edu

Principal Investigator:

Melissa Reimers, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

216-444-8311GUPTAS5@ccf.org

Principal Investigator:

Shilpa Gupta, MD

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Courtney Lambert, CRN

215-214-3787Courtney.lambert@fccc.edu

Principal Investigator:

Daniel Geynisman, MD

Vanderbilt- Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt- Ingram Cancer Center Clinical Trials Office (CTO)

1-800-811-8480CTIP@VUMC.ORG

Principal Investigator:

Brian Rini, MD

NEXT Oncology, Austin

Recruiting

Austin, Texas, United States, 78758

Contacts

Clinical Trial Navigator

737-610-5180hwatson@nextoncology.com

Principal Investigator:

Andrae Vandross, MD

NEXT Oncology, San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jordan Georg

210-580-9521jgeorg@nextoncology.com

Principal Investigator:

Ildefonso Rodriguez Rivera, MD

More Information

Sponsor

Deciphera Pharmaceuticals, LLC

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Advanced malignancies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Deciphera Pharmaceuticals, LLC on 2026-08-18.