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

Sponsor: Deciphera Pharmaceuticals, LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06287463

Patient View

This Phase 1/2 trial evaluates DCC-3084, an oral drug, in advanced cancers. Participants must provide tumor samples, have specific mutations, and meet health criteria. Exclusions include prior BRAF inhibitor use and certain health conditions. The study involves dose escalation and expansion phases, with potential for additional cancer modules.

Patient Parameters

Program Overview

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).

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)

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