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
- Diseases
- Lung cancer, Pancreatic cancer, Melanoma, Prostate cancer
- 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
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | United States | Unknown status |
| Roswell Park Comprehensive Cancer Center | Buffalo | United States | Unknown status |
| SCRI HealthOne | Denver | United States | Unknown status |
| NEXT Oncology- Virginia | Fairfax | United States | Unknown status |
| University of Southern California Norris Comprehensive Cancer Center | Los Angeles | United States | Unknown status |
| SCRI Oncology Partners | Nashville | United States | Unknown status |
| SCRI Florida Cancer Specialists | Orlando | United States | Unknown status |
| NEXT Oncology | San Antonio | United States | Unknown status |
| University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.