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

March 3, 2026 updated by: Deciphera Pharmaceuticals, LLC

A Master Protocol for the Multi-Cohort, Open-Label, Phase 1/2 Study of DCC-3084 as Monotherapy and in Combination With Other Antitumor Agents in Participants With Advanced Malignancies Driven by the MAPK Pathway

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California - Norris Comprehensive Cancer Center
      • San Francisco, California, United States, 94158
        • University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • SCRI HealthONE
    • Florida
      • Orlando, Florida, United States, 32827
        • SCRI Florida Cancer Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Comprehensive Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • SCRI Oncology Partners
    • Texas
      • San Antonio, Texas, United States, 78229
        • NEXT Oncology
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • NEXT Oncology Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 prior to 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 at Screening
  • Has a life expectancy of more than 6 months
  • In addition to these general inclusion criteria, participants must meet all the module cohort-specific inclusion criteria

Inclusion Criteria ModA Part 1 Cohort Specific:

  • Pathologically confirmed diagnosis of solid cancer and documentation of Kirsten rat sarcoma (KRAS), Harvey rat sarcoma virus (HRAS), neuroblastoma ras viral oncogene homolog (NRAS), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), v-raf murine sarcoma viral oncogene homolog C1(CRAF), and/or neurofibromatosis 1 (NF1) mutation
  • Have exhausted all available standard of care therapies that are known to provide benefit 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 therapy in the advanced or metastatic setting

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 prohibited with DCC-3084 within 14 days
  • Received any prior antitumor therapy or any investigational therapy within a specified 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 than the 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 excluded based 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCC-3084 Module A Escalation Phase (ModA Part 1)
Participants will receive DCC-3084 in ModA Part 1, Escalation Phase.
Drug: DCC-3084
Administered orally
Experimental: DCC-3084 Module A Expansion Phase (ModA Part 2)
Participants will receive DCC-3084 in ModA Part 2, Expansion Phase. Trial terminated prior to start of ModA Part 2.
Drug: DCC-3084
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
Time Frame: Cycle 1 (28 days)
DLTs reported during ModA Part 1.
Cycle 1 (28 days)
Objective Response Rate (ORR) (ModA Part 2)
Time Frame: Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.
Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR (ModA Part 1)
Time Frame: Start of Therapy to PD, Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
ORR is the percentage of participants with confirmed complete or partial remission based on indication specific criteria as defined in the protocol.
Start of Therapy to PD, Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Progression-Free Survival (PFS) (ModA Part 1 and 2)
Time Frame: Start of Therapy to PD or Death Due to Any Cause (Estimated up to 24 months)
PFS is the time from start of therapy to PD or death due to any cause.
Start of Therapy to PD or Death Due to Any Cause (Estimated up to 24 months)
Overall Survival (OS) (ModA Part 1 and 2)
Time Frame: Start of Therapy to Death Due to Any Cause (Estimated up to 36 months)
OS is the time from start of therapy to death from any cause.
Start of Therapy to Death Due to Any Cause (Estimated up to 36 months)
Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2)
Time Frame: Predose up to 12 hours postdose
Cmax (ModA Part 1 and 2)
Predose up to 12 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deciphera Pharmaceuticals, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Actual)

February 13, 2026

Study Completion (Actual)

February 13, 2026

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCC-3084-01-001
  • 2024-517829-12-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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