Clinical trial Recruiting at 8 sites Phase 1 Interventional Ages 18 and up

DCC-2812 in advanced kidney, bladder, and castration-resistant prostate cancers

Official title: 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

Run by Deciphera Pharmaceuticals, LLC · NCT06966024 · Data updated 2026-11-12

This trial will test whether the oral drug DCC-2812 is safe and shows early signs of benefit for people with advanced kidney (renal cell), bladder (urothelial), or castration-resistant prostate cancer.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorDeciphera Pharmaceuticals, LLC
Industry-sponsored
Locations8 sites (Boston, Massachusetts and 7 other locations)
StatusRecruiting
StartedAugust 27, 2025
Main results expectedFebruary 2029
Study endsFebruary 2029
Registry record updatedAugust 18, 2026
Trial IDNCT06966024 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with confirmed advanced or metastatic renal cell carcinoma, urothelial carcinoma, or castration-resistant prostate cancer who can take oral medication, have adequate organ function, and meet contraception requirements are the intended participants.

Probably not a fit

Patients who recently received other anticancer or investigational therapies, have impaired cardiac function, recent major surgery, or who cannot take oral medications are unlikely to be eligible or to receive benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter Phase 1, dose-escalation study of the selective GCN2 activator DCC-2812 given as monotherapy to patients with advanced or metastatic renal cell carcinoma, urothelial carcinoma, or castration-resistant prostate cancer. The trial focuses on characterizing safety, tolerability, pharmacokinetics, and any preliminary anti-tumor activity. Key eligibility features include the ability to take oral medication, adequate organ function, and no recent anticancer or investigational therapies or recent major surgery. Participants will be treated at specialized oncology centers with scheduled clinic visits for dosing, monitoring, and imaging.

Why it matters

Potential benefit: If successful, DCC-2812 could provide a new treatment option that targets a novel cellular stress pathway for patients with these advanced cancers.

How similar studies have gone: Activating the GCN2 pathway is a relatively novel approach with limited prior human data, so clinical benefit from this mechanism remains largely unproven.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • University of Michigan
    Ann Arbor, Michigan, United States
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting
  • Cleveland Clinic
    Cleveland, Ohio, United States
    Recruiting
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Vanderbilt- Ingram Cancer Center
    Nashville, Tennessee, United States
    Recruiting
Show 2 more locations
  • NEXT Oncology, Austin
    Austin, Texas, United States
    Recruiting
  • NEXT Oncology, San Antonio
    San Antonio, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.