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
| Registry | NCT06287463 |
|---|---|
| Status | Terminated - Trial terminated due to a business decision, not based on any safety concerns. |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, sequential, masking: none, treatment |
| Enrollment | 29 (Actual) |
| Sponsor | Deciphera Pharmaceuticals, LLC (Industry) |
| 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) |
| Interventions | DCC-3084 (Drug) |
| Dates | start 2024-05-14, primary completion 2026-02-13, completion 2026-02-13, first posted 2024-03-01, last updated 2026-03-05 |
| Locations | 9 sites in United States |
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All trials for Advanced Solid Tumor All trials for RAF Mutation All trials of DCC-3084
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| DCC-3084 Module A Escalation Phase (ModA Part 1) | Experimental | Drug: DCC-3084 | Participants will receive DCC-3084 in ModA Part 1, Escalation Phase. |
| DCC-3084 Module A Expansion Phase (ModA Part 2) | Experimental | Drug: DCC-3084 | Participants will receive DCC-3084 in ModA Part 2, Expansion Phase. Trial terminated prior to start of ModA Part 2. |
Sex: All, ages: 18 Years to any
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)
| Facility | City | Country | Status |
|---|---|---|---|
| University of Southern California - Norris Comprehensive Cancer Center | Los Angeles, California | United States | |
| University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center | San Francisco, California | United States | |
| SCRI HealthONE | Denver, Colorado | United States | |
| SCRI Florida Cancer Specialists | Orlando, Florida | United States | |
| Dana-Farber Cancer Institute | Boston, Massachusetts | United States | |
| Roswell Park Comprehensive Cancer Center | Buffalo, New York | United States | |
| SCRI Oncology Partners | Nashville, Tennessee | United States | |
| NEXT Oncology | San Antonio, Texas | United States | |
| NEXT Oncology Virginia | Fairfax, Virginia | United States |