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Trial Title:
Study of DCC-3084 in Participants with Advanced Malignancies Driven by the Mitogen-Activated Protein Kinase (MAPK) Pathway
NCT ID:
NCT06287463
Condition:
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)
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Advanced malignancies
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DCC-3084
Description:
Administered orally
Arm group label:
DCC-3084 Module A Escalation Phase (ModA Part 1)
Arm group label:
DCC-3084 Module A Expansion Phase (ModA Part 2)
Summary:
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).
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Southern California - Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anthony El-Khoueiry, MD
Facility:
Name:
SCRI HealthONE
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gerald Falchook, MD, MS
Facility:
Name:
SCRI Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cesar Perez Batista, MD
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vivek Subbiah, MD
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ildefonso Ismael Rodriguez Rivera, MD
Facility:
Name:
NEXT Oncology Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alexander Spira, MD, PhD
Start date:
May 14, 2024
Completion date:
August 2027
Lead sponsor:
Agency:
Deciphera Pharmaceuticals, LLC
Agency class:
Industry
Source:
Deciphera Pharmaceuticals, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06287463
