Clinical trial · Interventional
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
NCT06287463CI-TRIAL-00104704terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial terminated due to a business decision, not based on any safety concerns.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| BRAF Gene Mutation | — | UNRESOLVED | — |
| Castration-Resistant Prostate Cancer (CRPC) | Castration-Resistant Prostate Carcinoma | ALIAS | 0.85 |
| CRAF Gene Mutation | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| NF1 Mutation | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCC-3084 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DCC-3084 Module A Escalation Phase (ModA Part 1)
- description
- Participants will receive DCC-3084 in ModA Part 1, Escalation Phase.
- interventionNames
- Drug: DCC-3084
- type
- EXPERIMENTAL
- label
- DCC-3084 Module A Expansion Phase (ModA Part 2)
- description
- Participants will receive DCC-3084 in ModA Part 2, Expansion Phase. Trial terminated prior to start of ModA Part 2.
- interventionNames
- Drug: DCC-3084
Primary outcomes (2)
- measure
- Number of Participants with Dose-limiting Toxicities (DLTs) (ModA Part 1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.