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

NCT06287463 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: DCC-3084-01-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 9

Brief 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).

Conditions

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)

Keywords

Advanced malignancies

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• ORR (ModA Part 1)

  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)

  Start of Therapy to PD or Death Due to Any Cause (Estimated up to 24 months)

• Overall Survival (OS) (ModA Part 1 and 2)

  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)

  Predose up to 12 hours postdose

Study Arms (2)

DCC-3084 Module A Escalation Phase (ModA Part 1)

EXPERIMENTAL

Participants will receive DCC-3084 in ModA Part 1, Escalation Phase.

Drug: DCC-3084

DCC-3084 Module A Expansion Phase (ModA Part 2)

EXPERIMENTAL

Participants will receive DCC-3084 in ModA Part 2, Expansion Phase. Trial terminated prior to start of ModA Part 2.

Drug: DCC-3084

Interventions

DCC-3084 DRUG

Administered orally

DCC-3084 Module A Escalation Phase (ModA Part 1); DCC-3084 Module A Expansion Phase (ModA Part 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Deciphera Pharmaceuticals, LLC: lead

Study Sites (9)

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

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

San Francisco, California, 94158, United States

Location

SCRI HealthONE

Denver, Colorado, 80218, United States

Location

SCRI Florida Cancer Specialists

Orlando, Florida, 32827, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

NEXT Oncology Virginia

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Melanoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: May 14, 2024
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (9)