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Life sciences · Phase 1 Trial
ClinicalTrials.gov · October 22, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT02407509). This is a study registration, not published results. Lead sponsor: Royal Marsden NHS Foundation Trust. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 104 participants (ACTUAL). Conditions: Solid Tumours, Multiple Myeloma, Lung Cancer, Ovarian Cancer. Interventions: DRUG: VS-6766; DRUG: Everolimus. Primary outcome measures: Recommended Phase 2 Dose (RP2D) of VS-6766 , Up to 28 days; Recommended Phase 2 Dose (RP2D) of VS-6766 and Everolimus , Up to 28 days; Number of treatment emergent advese events (TEAEs) , Throughout time on trial per patient, estimated to be 6 months.; Number of treatment related adverse events (TRAEs) , Throughout time on trial per patient, estimated to be 6 months.. Brief summary: This study is a multi-centre, investigator-initiated, Phase I clinical trial evaluating different dosing schedules of VS-6766, given either alone or in combination with everolimus, in patients with advanced solid tumours or multiple myeloma. The study will investigate whether combining VS-6766 with everolimus can improve the treatment's effectiveness by blocking two important pathways that help cancer cells grow and survive. By targeting both pathways, researchers hope to reduce the likelihood of the cancer becoming resistant to treatment. In Part I of the study, participants will receive VS-6766 on different intermittent dosing schedules to identify the safest and most effective way to administer the drug. The treatment will be given by mouth either two or three times per week in four-week treatment cycles. If significant side effects are observed, the dose may be reduced. The dosing schedule identified as optimal in Part I will be taken forward into Part II. This phase will enrol patients whose cancers have specific genetic changes in the RAS/RAF/MEK pathway, including KRAS, NRAS, or BRAF mutations. Participants will receive either VS-6766 alone or VS-6766 in combination with everolimus. The study will assess the safety and tolerability of the treatment, how the body processes the drugs, and whether the treatment shows signs of benefiting patients. Particular focus will be placed on cancers driven by RAS/RAF pathway mutations, including KRAS-mutant lung cancer.