Study Of DCC-3084 In Participants With Advanced Malignancies Driven By The Mitogen-Activated Protein Kinase (MAPK) Pathway

Study Overview

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

This is a multicenter, Phase 1/2 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).

N/A

Advanced Solid Tumor
RAF Mutation
RAS Mutation
NF1 Mutation
Non-Small Cell Lung Cancer
Pancreatic Ductal Adenocarcinoma
Melanoma
BRAF Gene Mutation
CRAF Gene Mutation
Castration-Resistant Prostate Cancer (CRPC)

DRUG: DCC-3084

DCC-3084-01-001

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-02-23	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-05-22
First Submitted that Met QC Criteria 2024-02-23	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-05-23
First Posted (ACTUAL) 2024-03-01	Results First Posted N/A	Last Verified 2025-05

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

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.	DRUG: DCC-3084 Administered orally

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.

DRUG: DCC-3084

Administered orally

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)	DLTs reported during ModA Part 1.	Cycle 1 (28 days)
Objective Response Rate (ORR) (ModA Part 2)	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	Measure Description	Time Frame
ORR (ModA Part 1)	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)	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)	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)	Cmax (ModA Part 1 and 2)	Predose up to 12 hours postdose

Contacts and Locations

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

Study Contact

Name: Clinical Team

Phone Number: 785-830-2100

Email: clinicaltrials@deciphera.com

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Documented BRAF gene mutation
Pathologically confirmed diagnosis with PD after at least one prior line of therapy in the advanced or metastatic setting

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

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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