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VS-6766

DRUG7 trials

Sponsors

Verastem Inc., Royal Marsden NHS Foundation Trust, Institute of Cancer Research, United Kingdom, Verastem, Inc., Adrienne G. Waks

Conditions

Breast CancerEndometrioid CarcinomaFood EffectHormone Receptor Positive HER-2 Negative Breast CancerHormone Receptor-positive Breast CancerLow Grade Serous Ovarian CancerLung CancerMultiple Myeloma

Phase 1

Phase I Trial of VS-6766 Alone and in Combination With Everolimus
CompletedNCT02407509
Royal Marsden NHS Foundation TrustLung Cancer, Multiple Myeloma, Ovarian Cancer +1
Start: 2013-06-17End: 2025-10-15Target: 104Updated: 2026-01-29
Phase I Trial of Defactinib and VS-6766.
Active, not recruitingNCT03875820
Institute of Cancer Research, United KingdomEndometrioid Carcinoma, Low Grade Serous Ovarian Cancer, NSCLC +1
Start: 2017-12-12End: 2026-10-31Updated: 2026-03-10
Food Effect of VS-6766 in Healthy Adult Subjects
CompletedNCT05187169
Verastem, Inc.Food Effect
Start: 2021-12-16End: 2022-04-12Updated: 2022-05-10
VS-6766+Abema+Fulv in Met HR+/HER- BC
RecruitingNCT05608252
Adrienne G. WaksBreast Cancer, Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
Start: 2023-02-23End: 2028-12-31Target: 63Updated: 2025-10-29
A Phase 1/2 Study of Avutometinib (VS-6766) in Combination with Sotorasib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP 203)
Active, not recruitingCTIS2023-505107-24-00
Verastem Inc.Non-small cell lung cancer
Start: 2023-11-14Target: 48Updated: 2025-10-29

Phase 2

A Phase 2 Study of Avutometinib (VS-6766, a Dual RAF/MEK Inhibitor) Alone and In Combination with Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 201)
Active, not recruitingCTIS2024-516986-35-00
Verastem Inc.Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Start: 2021-09-06Target: 75Updated: 2025-12-09

Phase 3

A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP301)
RecruitingCTIS2023-508204-38-00
Verastem Inc.Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Start: 2024-07-02Target: 183Updated: 2026-01-06

Related Papers

Defactinib with avutometinib in patients with solid tumors: the phase 1 FRAME trial.
2025-06-275 citations
Abstract 6368: Correlative preclinical studies to elucidate mechanisms of synergy of the combination of the RAF/MEK clamp avutometinib and the FAK inhibitor defactinib in low grade serous ovarian cancer
Cancer Research2025-04-21
Abstract C026: Initial safety, pharmacokinetics, and recommended Phase 2 dose from RAMP 203: A Phase 1/2 study of Avutometinib + Sotorasib in KRAS G12C Mutant Non-Small Cell Lung Cancer
Molecular Cancer Therapeutics2023-12-016 citations
Abstract 3461: Preclinical and clinical evaluation of the RAF/MEK clamp avutometinib (VS-6766) in combination with the mTOR inhibitor everolimus for the treatment of <i>KRAS</i> mutated non-small cell lung cancer
Cancer Research2023-04-041 citations
Abstract CT204: A phase 1/2 study of VS-6766 in combination with sotorasib in patients with KRAS G12C mutant non-small cell lung cancer (NSCLC) (RAMP 203)
Cancer Research2022-06-152 citations
Abstract 3476: Mechanistic evaluation of VS-6766 (dual RAF/MEK inhibitor) and defactinib (FAK inhibitor) in low-grade serous ovarian cancer models with correlations to clinical response
Cancer Research2022-06-151 citations
ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of VS-6766 (RAF/MEK clamp) alone and in combination with defactinib (FAK inhibitor) in recurrent low-grade serous ovarian cancer (LGSOC).
Journal of Clinical Oncology2022-06-018 citations
Phase I trial of the RAF/MEK clamp VS-6766 in combination with everolimus using an intermittent schedule with expansion in NSCLC across multiple <i>KRAS </i>variants.
Journal of Clinical Oncology2022-06-017 citations
A phase 1/2 study of VS-6766 (RAF/MEK clamp) in combination with sotorasib (G12C inhibitor) in patients with KRAS G12C mutant non–small cell lung cancer (NSCLC) (RAMP 203).
Journal of Clinical Oncology2022-06-014 citations
Abstract P046: ENGOT-ov60/GOG3052/RAMP 201: A phase 2 study of VS-6766 (dual RAF/MEK inhibitor) alone and in combination with defactinib (FAK inhibitor) in recurrent low-grade serous ovarian cancer (LGSOC)
Molecular Cancer Therapeutics2021-12-011 citations
Abstract P036: Trial in progress: Combination of the dual RAF/MEK inhibitor VS-6766 with the mTOR inhibitor everolimus with expansion in patients with KRAS mutant NSCLC
Molecular Cancer Therapeutics2021-12-01
Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT)
BMJ Open2021-09-013 citations
Abstract 1425: Synergistic antitumor efficacy of the dual RAF/MEK inhibitor VS-6766 with FAK inhibition for treatment of RAS-dependent solid tumors
Cancer Research2021-07-012 citations
ENGOT-ov60/GOG3052/RAMP 201: A phase 2 study of VS-6766 (dual RAF/MEK inhibitor) alone and in combination with defactinib (FAK inhibitor) in recurrent low-grade serous ovarian cancer (LGSOC).
Journal of Clinical Oncology2021-05-205 citations
Intermittent schedules of the oral RAF-MEK inhibitor CH5126766/VS-6766 in patients with RAS/RAF-mutant solid tumours and multiple myeloma: a single-centre, open-label, phase 1 dose-escalation and basket dose-expansion study.
2020-10-2853 citations
Abstract CT143: Phase I study of the combination of a RAF-MEK inhibitor CH5126766 and FAK inhibitor defactinib in an intermittent dosing schedule with expansions in <i>KRAS</i> mutant cancers
Cancer Research2020-08-1521 citations
Abstract 6406: FAK and MEK co-targeting: A new multimodal precision therapy for <i>GNAQ</i>-driven uveal melanoma
Cancer Research2020-08-15
Results from the biomarker-driven basket trial of RO5126766 (CH5127566), a potent RAF/MEK inhibitor, in RAS- or RAF-mutated malignancies including multiple myeloma.
Journal of Clinical Oncology2017-05-2029 citations
Updated efficacy and safety results from the phase I study of intermittent dosing of the dual MEK/RAF inhibitor, RO5126766 in patients (pts) with <i>RAS/RAF</i> mutated advanced solid tumours.
Journal of Clinical Oncology2016-05-206 citations