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NCT Number: NCT06966024

Study of DCC-2812 in Participants With Advanced Genitourinary Cancers

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Carcinoma, Transitional Cell Castration-resistant Prostate Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DCC-2812

Drug

Administered orally

Primary outcomes

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

    Time frame: Cycle 1 (28 days)

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

    Time frame: Up to 42 months

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

    Time frame: Up to 42 months

Secondary outcomes

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

    Time frame: Up to 42 months

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

    Time frame: Up to 42 months

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

    Time frame: Predose up to 24 hours postdose (up to 42 months)

  4. PK: Time to Reach Cmax (Tmax)

    Time frame: Predose up to 24 hours postdose (up to 42 months)

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

    Time frame: Predose up to 24 hours postdose (up to 42 months)

  6. PK: Trough Plasma Concentration (Ctrough)

    Time frame: Predose up to 24 hours postdose (up to 42 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Team

CONTACT

[email protected]

888-724-3274

Sponsors and collaborators

Lead sponsor

Deciphera Pharmaceuticals, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 11, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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