Study of DCC-2812 in Participants With Advanced Genitourinary Cancers

May 18, 2026 updated by: Deciphera Pharmaceuticals, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Bicky Thapa, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Ulka Vaishampayan, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt- Ingram Cancer Center
        • Principal Investigator:
          • Brian Rini, MD
        • Contact:
          • Vanderbilt- Ingram Cancer Center Clinical Trials Office (CTO)
          • Phone Number: 1-800-811-8480
          • Email: CTIP@VUMC.ORG
    • Texas
      • Austin, Texas, United States, 78758
        • Recruiting
        • NEXT Oncology, Austin
        • Principal Investigator:
          • Andrae Vandross, MD
        • Contact:
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology, San Antonio
        • Principal Investigator:
          • Ildefonso Rodriguez Rivera, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCC-2812
Participants will receive DCC-2812 in dose escalation manner per dosing regimen depending upon evolving pharmacokinetic (PK), pharmacodynamic, and safety data.
Drug: DCC-2812
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Dose-limiting Toxicities (DLTs)
Time Frame: Cycle 1 (28 days)
Cycle 1 (28 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 42 months
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
Up to 42 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Radiographic Duration of Response (rDOR) per RECIST v1.1
Time Frame: Up to 42 months
Up to 42 months
PK: Maximum Observed Plasma Drug Concentration (Cmax)
Time Frame: Predose up to 24 hours postdose (up to 42 months)
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)
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)
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)
Predose up to 24 hours postdose (up to 42 months)
Radiographic Objective Response Rate (rORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame: Up to 42 months
Up to 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deciphera Pharmaceuticals, LLC

Investigators

  • Study Director: Clinical Team, Deciphera Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2025

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCC-2812-01-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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