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

Description

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).

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)

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern California - Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Denver

SCRI HealthONE, Denver, Colorado, United States, 80218

Orlando

SCRI Florida Cancer Specialists, Orlando, Florida, United States, 32827

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

San Antonio

NEXT Oncology, San Antonio, Texas, United States, 78229

Fairfax

NEXT Oncology Virginia, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Deciphera Pharmaceuticals, LLC,

Study Record Dates

2027-08