TerminatedPhase 1

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

Stopped: Trial terminated due to a business decision, not based on any safety concerns.

United States29 participantsStarted 2024-05-14

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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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 pr…

What they're measuring

Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)

Timeframe: Cycle 1 (28 days)

Objective Response Rate (ORR) (ModA Part 2)

Timeframe: Start of Therapy to Progressive Disease (PD), Death Due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)

Trial details

NCT IDNCT06287463

SponsorDeciphera Pharmaceuticals, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-13