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NCT06287463TerminatedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 5 Mar 2026

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

Brief summary (registry, in English)

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).

Status (registry)
Terminated
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
29 (actual)
First submitted
23 Feb 2024
Start date
14 May 2024
Primary completion date
13 Feb 2026
Lead sponsor
Deciphera Pharmaceuticals, LLC
NCT number
NCT06287463

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior treatment with certain BRAF dimer inhibitors
  • 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
  • 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
  • Major surgery within 28 days of the first dose of study drug

Other illness

  • Known allergy or hypersensitivity to any component of the study drug
  • Impaired cardiac function
  • History of recent thrombotic or embolic events
  • Malabsorption syndrome or other illness that could affect oral absorption

Other

  • General Exclusion Criteria ModA Part 1 and 2:
  • Female participant is pregnant or lactating
  • In addition to the general exclusion criteria, participants will also be excluded based on the cohort-specific exclusion criteria
  • 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)

Who the study is looking for

  • 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
  • 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
  • Documented BRAF gene mutation
  • Pathologically confirmed diagnosis with PD after at least one prior line of therapy in the advanced or metastatic setting

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Dana-Farber Cancer InstituteBostonUnited StatesUnknown status
Roswell Park Comprehensive Cancer CenterBuffaloUnited StatesUnknown status
SCRI HealthOneDenverUnited StatesUnknown status
NEXT Oncology- VirginiaFairfaxUnited StatesUnknown status
University of Southern California Norris Comprehensive Cancer CenterLos AngelesUnited StatesUnknown status
SCRI Oncology PartnersNashvilleUnited StatesUnknown status
SCRI Florida Cancer SpecialistsOrlandoUnited StatesUnknown status
NEXT OncologySan AntonioUnited StatesUnknown status
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterSan FranciscoUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.