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

INTRODUCTION

  • Org Study ID: DCC-2812-01-001
  • Secondary ID: N/A
  • NCT ID: NCT06966024
  • 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.

  • Overall Status
    Recruiting
  • Start Date
    August 27, 2025
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of Participants with Dose-limiting Toxicities (DLTs)

Primary Outcome 1 - Timeframe: Cycle 1 (28 days)

Primary Outcome 2 - Measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Primary Outcome 2 - Timeframe: Up to 42 months

Primary Outcome 3 - Measure: Number of Participants With Dose Reduction

Primary Outcome 3 - Timeframe: Up to 42 months

Primary Outcome 4 - Measure: Interruption

Primary Outcome 4 - Timeframe: N/A

Primary Outcome 5 - Measure: or Discontinuation of Study Drug Due to TEAEs

Primary Outcome 5 - Timeframe: N/A

CONDITION

  • Renal Cell Carcinoma
  • Urothelial Carcinoma
  • Castration-resistant Prostate Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Clinical Team

Role: Study Director

Affiliation: Deciphera Pharmaceuticals, LLC

Overall Contact

Name: Clinical Team

Phone: 888-724-3274

Email: [email protected]

LOCATION

Facility Status Contact
Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Bicky Thapa, MD
617-632-3000
[email protected]

Principal Investigator
Bicky Thapa, MD

Facility: University of Michigan
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact: Contact

800-865-1125
[email protected]

Principal Investigator
Ulka Vaishampayan, MD

Facility: Vanderbilt- Ingram Cancer Center
Nashville, Tennessee 37232
United States
Status: Recruiting Contact: Contact
Vanderbilt- Ingram Cancer Center Clinical Trials Office (CTO)
1-800-811-8480
[email protected]

Principal Investigator
Brian Rini, MD

Facility: NEXT Oncology, Austin
Austin, Texas 78758
United States
Status: Recruiting Contact: Contact
Clinical Trial Navigator
737-610-5180
[email protected]

Principal Investigator
Andrae Vandross, MD

Facility: NEXT Oncology, San Antonio
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Jordan Georg
210-580-9521
[email protected]

Principal Investigator
Ildefonso Rodriguez Rivera, MD