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)Drugs
DCC-3084Summary
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).
Locations
6 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Anthony El-Khoueiry, MD
Status
- RECRUITING
Contact Person
- Gerald Falchook, MD, MS
Status
- RECRUITING
Contact Person
- Cesar Perez Batista, MD
Status
- RECRUITING
Contact Person
- Vivek Subbiah, MD
Status
- RECRUITING
Contact Person
- Ildefonso Ismael Rodriguez Rivera, MD
Status
- RECRUITING
Contact Person
- Alexander Spira, MD, PhD
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)
Study Plan
DCC-3084 Module A Escalation Phase (ModA Part 1)
EXPERIMENTAL
Participants will receive DCC-3084 in ModA Part 1, Escalation Phase.
DRUG:
DCC-3084Description:
Administered orally
DCC-3084 Module A Expansion Phase (ModA Part 2)
EXPERIMENTAL
Participants will receive DCC-3084 in ModA Part 2, Expansion Phase.
DRUG:
DCC-3084Description:
Administered orally
Outcome Measures
Primary Outcome Measures
Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
Objective Response Rate (ORR) (ModA Part 2)
Secondary Outcome Measures
ORR (ModA Part 1)
Progression-Free Survival (PFS) (ModA Part 1 and 2)
Overall Survival (OS) (ModA Part 1 and 2)
Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax) (ModA Part 1 and 2)
Timeline
Last Updated
November 15, 2024Start Date
March 1, 2024Today
February 5, 2025Completion Date ( Estimated )
August 1, 2027
Sponsors of this trial
Lead Sponsor
Deciphera Pharmaceuticals, LLC