Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 Study of Avutometinib (VS-6766) in Combination With Sotorasib With or Without Defactinib in Patients With KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC) (RAMP203)
Interventional
Phase 1/Phase 2
Verastem, Inc. (Voir sur ClinicalTrials)
avril 2022
avril 2027
05 avril 2025
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination
with sotorasib with or without defactinib in patients with KRAS G12C Non-Small Cell Lung
Cancer (NSCLC) in patients who have been exposed to prior G12C inhibitor and those who
have not been exposed to prior G12C inhibitor.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Jaafar BENNOUNA | 05/05/2025 07:12:10 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU of Lille - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Male or female patients ≥ 18 years of age
- Histologic or cytologic evidence of NSCLC
- Known KRAS G12C mutation
- Either exposed or not exposed to a KRAS inhibitor to be included in Part A
(avutometinib + sotorasib + defactinib) and not exposed to KRAS inhibitor to be
included in Part B (avutometinib + sotorasib + defactinib), Cohort 1
- Received at least 1 dose of a G12C inhibitor to be included in Part B, Cohort 2
(avutometinib + sotorasib + defactinib)
- Must have received appropriate treatment with at least one prior systemic regimen,
but no more than 2 prior regimens, for Stage 3B-C or 4 NSCLC
- Measurable disease according to RECIST 1.1
- An Eastern Cooperative Group (ECOG) performance status ≤ 1
- Adequate organ function
- Adequate recovery from toxicities related to prior treatments
- Agreement to use highly effective method of contraceptive
- Male or female patients ≥ 18 years of age
- Histologic or cytologic evidence of NSCLC
- Known KRAS G12C mutation
- Either exposed or not exposed to a KRAS inhibitor to be included in Part A
(avutometinib + sotorasib + defactinib) and not exposed to KRAS inhibitor to be
included in Part B (avutometinib + sotorasib + defactinib), Cohort 1
- Received at least 1 dose of a G12C inhibitor to be included in Part B, Cohort 2
(avutometinib + sotorasib + defactinib)
- Must have received appropriate treatment with at least one prior systemic regimen,
but no more than 2 prior regimens, for Stage 3B-C or 4 NSCLC
- Measurable disease according to RECIST 1.1
- An Eastern Cooperative Group (ECOG) performance status ≤ 1
- Adequate organ function
- Adequate recovery from toxicities related to prior treatments
- Agreement to use highly effective method of contraceptive
- Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
- History of prior malignancy, with the exception of curatively treated malignancies
- Major surgery within 4 weeks, minor surgery within 2 weeks (excluding placement of
vascular access)
- History of treatment with a direct and specific inhibitor of MEK
- Exposure to strong CYP3A4 inhibitors or inducers within 14 days prior to the first
dose and during the course of therapy
- Symptomatic brain metastases requiring steroids or other local interventions.
- Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
- Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is
active
- Active skin disorder that has required systemic therapy within the past year
- History of rhabdomyolysis
- Concurrent ocular disorders
- Concurrent heart disease or severe obstructive pulmonary disease
- Inability to swallow oral medications
- Female patients that are pregnant or breastfeeding
- Previously treated with sotorasib and were dose reduced due to toxicity