Study of DCC-3084 in Participants With Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway

Last updated: March 3, 2026
Sponsor: Deciphera Pharmaceuticals, LLC
Overall Status: Terminated

Phase

1

Condition

Neoplasms

Non-small Cell Lung Cancer

Pancreatic Disorders

Treatment

DCC-3084

Clinical Study ID

NCT06287463
DCC-3084-01-001
2024-517829-12-00
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter clinical trial to evaluate DCC-3084 alone or in combination with other cancer therapies in participants with advanced cancers. Module A will enroll participants with advanced/metastatic solid tumors. Additional modules exploring other cancers may be added to the master protocol at a later date. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion).

Eligibility Criteria

Inclusion

Inclusion Criteria:

General Inclusion Criteria ModA Part 1 and 2:

  • Able to take oral medication

  • If a female is of childbearing potential, must have a negative pregnancy test priorto enrollment and all participants agree to follow the contraception requirements

  • Adequate organ function and electrolytes

  • Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of 0 to 1 atScreening

  • Has a life expectancy of more than 6 months

  • In addition to these general inclusion criteria, participants must meet all themodule cohort-specific inclusion criteria

Inclusion Criteria ModA Part 1 Cohort Specific:

  • Pathologically confirmed diagnosis of solid cancer and documentation of Kirsten ratsarcoma (KRAS), Harvey rat sarcoma virus (HRAS), neuroblastoma ras viral oncogenehomolog (NRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), v-raf murinesarcoma viral oncogene homolog C1(CRAF), and/or neurofibromatosis 1 (NF1) mutation

  • Have exhausted all available standard of care therapies that are known to providebenefit for the participant's condition, as judged by the Investigator

Inclusion Criteria ModA Part 2 Cohort Specific:

  • Documented BRAF gene mutation

  • Pathologically confirmed diagnosis with PD after at least one prior line of therapyin the advanced or metastatic setting

Exclusion

Exclusion Criteria:

General Exclusion Criteria ModA Part 1 and 2:

  • Prior treatment with certain BRAF dimer inhibitors

  • Female participant is pregnant or lactating

  • Received any prior or concurrent medications or therapies known to be prohibitedwith DCC-3084 within 14 days

  • Received any prior antitumor therapy or any investigational therapy within aspecified timeframe prior to first dose of DCC-3084

  • Known allergy or hypersensitivity to any component of the study drug

  • Invasive malignancy within 2 years prior to the first dose of study drug other thanthe study indication or specific types of cancer treated with curative intent

  • Have not recovered from all clinically relevant toxicities from prior therapy

  • Impaired cardiac function

  • History of recent thrombotic or embolic events

  • Malabsorption syndrome or other illness that could affect oral absorption

  • Major surgery within 28 days of the first dose of study drug

  • In addition to the general exclusion criteria, participants will also be excludedbased on the cohort-specific exclusion criteria

Exclusion Criteria: Module A Part 2 Cohort Specific:

• Has known co-occurring mutation of KRAS, HRAS, NRAS, NF1, epidermal growth factor receptor, Phosphoinositide-3-kinase, catalytic, alpha polypeptide (PI3KCA), or Phosphatase and TENsin homolog deleted on chromosome 10 (PTEN)

Study Design

Total Participants: 29
Treatment Group(s): 1
Primary Treatment: DCC-3084
Phase: 1
Study Start date:
May 14, 2024
Estimated Completion Date:
February 13, 2026

Connect with a study center

  • University of Southern California - Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

    San Francisco, California 94158
    United States

    Site Not Available

  • University of Southern California - Norris Comprehensive Cancer Center

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • SCRI HealthONE

    Denver, Colorado 80218
    United States

    Site Not Available

  • SCRI HealthONE

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • SCRI Florida Cancer Specialists

    Orlando, Florida 32827
    United States

    Site Not Available

  • SCRI Florida Cancer Specialists

    Orlando 4167147, Florida 4155751 32827
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14263
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo 5110629, New York 5128638 14263
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • NEXT Oncology Virginia

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • NEXT Oncology Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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