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RecruitingInterventionalPhase 1

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

NCT ID: NCT06966024Sponsor: Deciphera Pharmaceuticals, LLCLast updated: 2026-05-20

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.

Arms & interventions

  • DrugDCC-2812

    Administered orally

Outcome measures

Primary

  • 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

Secondary

  • Radiographic Objective Response Rate (rORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Up to 42 months

  • Radiographic Duration of Response (rDOR) per RECIST v1.1

    Time frame: Up to 42 months

  • PK: Maximum Observed Plasma Drug Concentration (Cmax)

    Time frame: Predose up to 24 hours postdose (up to 42 months)

  • PK: Time to Reach Cmax (Tmax)

    Time frame: Predose up to 24 hours postdose (up to 42 months)

  • PK: Area Under the Plasma Concentration-time Curve (AUC)

    Time frame: Predose up to 24 hours postdose (up to 42 months)

  • PK: Trough Plasma Concentration (Ctrough)

    Time frame: Predose up to 24 hours postdose (up to 42 months)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (5)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Recruiting
Bicky Thapa, MD · Contact
617-632-3000bicky_thapa@dfci.harvard.edu
Bicky Thapa, MD · Principal Investigator

University of Michigan

Ann Arbor, Michigan, 48109

Recruiting
· Contact
800-865-1125CancerAnswerLine@med.umich.edu
Ulka Vaishampayan, MD · Principal Investigator

Vanderbilt- Ingram Cancer Center

Nashville, Tennessee, 37232

Recruiting
Vanderbilt- Ingram Cancer Center Clinical Trials Office (CTO) · Contact
1-800-811-8480CTIP@VUMC.ORG
Brian Rini, MD · Principal Investigator

NEXT Oncology, Austin

Austin, Texas, 78758

Recruiting
Clinical Trial Navigator · Contact
737-610-5180hwatson@nextoncology.com
Andrae Vandross, MD · Principal Investigator

NEXT Oncology, San Antonio

San Antonio, Texas, 78229

Recruiting
Jordan Georg · Contact
210-580-9521jgeorg@nextoncology.com
Ildefonso Rodriguez Rivera, MD · Principal Investigator