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Renal Cell CarcinomaPhase 1NCT06966024

Study of DCC-2812 in Participants With Advanced Genitourinary Cancers

A Phase 1 study testing DCC-2812 in people with Renal Cell Carcinoma and Urothelial Carcinoma, run by Deciphera Pharmaceuticals, LLC at 8 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DCC-2812
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
8 sitesUnited States
Study dates
27 Aug 2025to Feb 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Team contact

888-724-3274

clinicaltrials@deciphera.com

8 sites in 1 country

United States8 sites, 8 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

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

    Ulka Vaishampayan, MD

    Recruiting

  • NEXT Oncology, Austin

    Austin, Texas, 78758

    Clinical Trial Navigator, 737-610-5180, hwatson@nextoncology.com

    Andrae Vandross, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Bicky Thapa, MD, 617-632-3000, bicky_thapa@dfci.harvard.edu

    Bicky Thapa, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    216-444-8311, GUPTAS5@ccf.org

    Shilpa Gupta, MD

    Recruiting

  • Vanderbilt- Ingram Cancer Center

    Nashville, Tennessee, 37232

    Vanderbilt- Ingram Cancer Center Clinical Trials Office (CTO), 1-800-811-8480, CTIP@VUMC.ORG

    Brian Rini, MD

    Recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Courtney Lambert, CRN, 215-214-3787, Courtney.lambert@fccc.edu

    Daniel Geynisman, MD

    Recruiting

  • NEXT Oncology, San Antonio

    San Antonio, Texas, 78229

    Jordan Georg, 210-580-9521, jgeorg@nextoncology.com

    Ildefonso Rodriguez Rivera, MD

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Hannah Black, 314-362-9913, hannahblack@wustl.edu

    Melissa Reimers, MD

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
DCC-2812
Keywords
Advanced malignancies
Medical subject headings
Carcinoma, Renal Cell, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCC-2812Drug

    Administered orally

Study groups in NCT06966024
Study groupRoleWhat they receive
DCC-2812ExperimentalParticipants will receive DCC-2812 in dose escalation manner per dosing regimen depending upon evolving pharmacokinetic (PK), pharmacodynamic, and safety data.
Receives: Drug: DCC-2812

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose-limiting Toxicities (DLTs)

    Measured: Cycle 1 (28 days)

  2. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Up to 42 months

  3. Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs

    Measured: Up to 42 months

Secondary outcomes (6)

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

    Measured: Up to 42 months

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

    Measured: Up to 42 months

  3. PK: Maximum Observed Plasma Drug Concentration (Cmax)

    Measured: Predose up to 24 hours postdose (up to 42 months)

  4. PK: Time to Reach Cmax (Tmax)

    Measured: Predose up to 24 hours postdose (up to 42 months)

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

    Measured: Predose up to 24 hours postdose (up to 42 months)

  6. PK: Trough Plasma Concentration (Ctrough)

    Measured: Predose up to 24 hours postdose (up to 42 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2025
  2. Study start27 Aug 2025
  3. Primary completionFeb 2029 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06966024
Sponsor's protocol ID
DCC-2812-01-001
Status last verified
Aug 2026
First submitted
2 May 2025
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DCC-2812 in people with Renal Cell Carcinoma and Urothelial Carcinoma, run by Deciphera Pharmaceuticals, LLC at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Team (888-724-3274, clinicaltrials@deciphera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose-limiting Toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06966024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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