ACTIVE_NOT_RECRUITING

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

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)Advanced malignancies

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-05-14

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06287463

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

University of Southern California - Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

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

San Francisco, California, 94158

United States

SCRI HealthONE

Denver, Colorado, 80218

United States

SCRI Florida Cancer Specialists

Orlando, Florida, 32827

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

United States

SCRI Oncology Partners

Nashville, Tennessee, 37203

United States

NEXT Oncology

San Antonio, Texas, 78229

United States

NEXT Oncology Virginia

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-05-14

Study Completion Date2027-08

Study Record Updates

Study Start Date2024-05-14

Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

Advanced malignancies

Additional Relevant MeSH Terms

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)