NCT06966024

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
34mo left

Started Aug 2025

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Aug 2025Feb 2029

First Submitted

Initial submission to the registry

May 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

August 27, 2025

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

May 2, 2025

Last Update Submit

April 17, 2026

Conditions

Urothelial CarcinomaCastration-resistant Prostate CancerRenal Cell Carcinoma

Keywords

Advanced malignancies

Outcome Measures

Primary Outcomes (3)

  • Number of Participants with Dose-limiting Toxicities (DLTs)

    Cycle 1 (28 days)

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

    Up to 42 months

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

    Up to 42 months

Secondary Outcomes (6)

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

    Up to 42 months

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

    Up to 42 months

  • PK: Maximum Observed Plasma Drug Concentration (Cmax)

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

  • PK: Time to Reach Cmax (Tmax)

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

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

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

  • +1 more secondary outcomes

Study Arms (1)

DCC-2812

EXPERIMENTAL

Participants will receive DCC-2812 in dose escalation manner per dosing regimen depending upon evolving pharmacokinetic (PK), pharmacodynamic, and safety data.

Drug: DCC-2812

Interventions

DCC-2812DRUG

Administered orally

DCC-2812

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Vanderbilt- Ingram Cancer Center

Nashville, Tennessee, 37232, United States

RECRUITING

NEXT Oncology, Austin

Austin, Texas, 78758, United States

RECRUITING

NEXT Oncology, San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal CellCarcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Clinical Team

    Deciphera Pharmaceuticals, LLC

    STUDY DIRECTOR

Central Study Contacts

Clinical Team

CONTACT

888-724-3274clinicaltrials@deciphera.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 11, 2025

Study Start

August 27, 2025

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

US(4)