A Study to Characterize the Safety, Tolerability, and Preliminary Efficacy of CFT1946 as Monotherapy and Combination Therapy in Subjects With BRAF V600 Mutant Solid Tumors
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
89actual
Sites
26
Countries
France, Germany, Spain +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-12-08 | actual | When the study began enrolling |
| Primary completion | 2025-11-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-11-05 | actual | The whole study's end, after follow-up |
| First posted | 2022-12-30 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Solid Tumors
- Melanoma
- NSCLC
- CRC
- ATC
Interventions
- Drug: CFT1946
- Drug: Trametinib
- Drug: Cetuximab
Primary outcomes
what the primary-completion date above is the date OFFrequency and severity of AEs and SAEs
measured From enrollment until 30 days after completion of study treatment
Incidence of dose limiting toxicities (DLTs)
measured From enrollment until 28 days after first dose
Number of subjects with changes between baseline and post-baseline safety assessments based on safety laboratory results graded by CTCAE v5.0
measured From enrollment until 30 days after completion of study treatment
Frequency of dose interruptions and dose reductions
measured From enrollment until 30 days after completion of study treatment
Frequency of AEs leading to discontinuation of study treatment(s)
measured From enrollment until 30 days after completion of study treatment
Overall response rate (ORR)
measured Up to approximately 43 months
Disease control rate (DCR) at 3, 6, and 12 months
measured Up to 12 months
Duration of Response (DOR)
measured Up to approximately 43 months
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