NCT05180422

A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis

A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis.

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Criterium, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, non-randomized, open-label, phase I/II study to evaluate the safety and tolerability of AMG 510 plus MVASI in subjects with advanced KRAS p.G12C mutant non-small cell lung cancer (NSCLC) with small, untreated brain metastases.

Detailed description

Each patient is scheduled to receive AMG 510 (KRASG12C inhibitor) in combination with MVASI (vascular endothelial growth factor \[VEGF\] inhibitor; bevacizumab biosimilar); both drugs will be provided by the study: AMG 510: Continuous once daily (QD) oral dosing (Days 1-21 each cycle) with or without food. MVASI: Intravenous (i.v.) infusion every 21 days (i.e. Day 1 of each 21-day cycle). The study will be conducted in 2 parts. The dose expansion part of the study (Part 2) can open once the maximum tolerated dose (MTD) and/or a biologically active dose (e.g. recommended phase 2 dose \[RP2D\]) using a 3+3 study design has been determined in Part 1. CNS response will be assessed using RANO-BM criteria, and non-CNS objective response will be based on Solid Tumor Response Criteria \[RECIST v1.1\] assessment of overall tumor burden at baseline versus that detected on subsequent CT/MRI re-scans. This includes a brain MRI on C2D1 (21 days) and a CT chest/abdomen/pelvis (C/A/P) at 6 weeks, then brain MRI at 15 weeks and CT C/A/P imaging at 12-16 weeks, and then every 4 cycles (every 12 weeks) while on study. It is intended that patients will be treated until disease progression or intolerable toxicity. Patients will be followed for survival for up to 18 months after ending study treatment.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AMG 510	Continuous once daily (QD) oral dosing (Days 1-21 each cycle) with or without food.
DRUG	MVASI	Intravenous (i.v.) infusion every 21 days (i.e. Day 1 of each 21-day cycle).

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2022-01-06
• Last updated: 2023-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study