Study name: AMG193: A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of AMG 193 in Subjects with Methylthioadenosine Phosphorylase (MTAP)-deleted Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC)
Histology
NSCLC
Tumor stage
Stage IV
Host / recruiting sites
Erasmus MC
Enrollment
Recruiting
Therapy line
Later line (≥2L)
Design
A multicenter, phase 2, open-label study evaluating efficacy, safety, tolerability, and PK of AMG 193 in subjects with metastatic or locally advanced MTAP-deleted NSCLC who have previously received at least one line of treatment.
Intervention
This study will be conducted in 2 parts:
Part 1 will evaluate 2 active dose levels of AMG 193. Subjects will be randomized to either the target dose of 800 mg or 1200 mg of AMG 193 administered oral daily continuously in 28-day cycles.
Part 2 will be a dose expansion phase for 1 or both doses. Part 2 will continue to enroll up to approximately 100 subjects per dose level (with Part 1 and Part 2 combined).
Key inclusion criteria
Performance Status ≤ 1 and histologically or cytologically confirmed metastatic or unresectable locally advanced MTAP-deleted non-small cell lung cancer.
Subjects must have progressed after receiving platinum-based doublet chemotherapy and a checkpoint inhibitor (unless contraindicated).
Subjects with stable treated brain metastases or untreated asymptomatic brain metastases ≤ 2 cm in size per lesion are eligible.
Key exclusion criteria
Subjects with tumors harboring the following mutations amenable to targeted therapies will be excluded: epidermal growth factor receptor (EGFR) / ALK receptor tyrosine kinase (ALK) / ROS proto-oncogene 1 (ROS1) / neurotrophic tyrosine receptor kinase (NTRK) / MET proto-oncogene (MET) / B-Raf proto-oncogene (BRAF)/ RET proto oncogene (RET) / Human epidermal growth factor receptor 2 (HER2) / KRAS proto oncogene (KRAS).
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