Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT05364073

Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

A Phase 1b Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
160 (actual)
Sponsor
ArriVent BioPharma, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating, including uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be enrolled into one of 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).

Conditions

Interventions

TypeNameDescription
DRUGFurmonertinibFurmonertinib tablet
DRUGFurmonertinibFurmonertinib tablet
DRUGFurmonertinibFurmonertinib tablet
DRUGFurmonertinibFurmonertinib tablet
DRUGFurmonertinibFurmonertinib tablet

Timeline

Start date
2022-06-30
Primary completion
2025-06-03
Completion
2026-12-31
First posted
2022-05-06
Last updated
2026-03-13

Locations

42 sites across 11 countries: United States, Australia, Canada, China, France, Italy, Japan, Netherlands, South Korea, Spain, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT05364073. Inclusion in this directory is not an endorsement.