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

ArriVent BioPharma, Inc.42 sites in 11 countries160 target enrollmentJune 30, 2022

ConditionsNon-Small Cell Lung Cancer (NSCLC)Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer HER2 Exon 20 Mutations EGFR Exon 20 Mutations EGFR Uncommon Mutations, Including G719X and S768I

InterventionsFurmonertinib

DrugsFurmonertinib

Overview

Phase: Phase 1
Intervention: Furmonertinib
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Sponsor: ArriVent BioPharma, Inc.
Enrollment: 160
Locations: 42
Primary Endpoint: Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

June 30, 2022

End Date

December 31, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

ArriVent BioPharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
•Disease that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable; or for whom a clinical trial of an investigational agent is a recognized standard of care.
•Documented radiologic disease progression during or after the last systemic anti-cancer therapy before the first dose of furmonertinib.
•For patients with Epidermal Growth Factor Receptor (EGFR) mutations sensitive to osimertinib, the patient must have received osimertinib prior to study enrollment in regions where osimertinib is approved, including the US.
•Stage 1 dose escalation and backfill cohorts and Stage 2 Cohorts 1, 2, 3 and 4:
•Patients with CNS metastases (including leptomeningeal disease) may be eligible if meeting additional protocol specified criteria.
•Stage 1 Dose Escalation and Backfill Cohorts Inclusion Criteria:
•\- Documented validated results from local testing of tumor tissue or blood confirming the presence of an activating, including uncommon, EGFR mutation or HER2 exon 20 insertion mutation performed at a CLIA-or equivalently certified laboratory.
•Stage 2 Cohort 1 Previously Treated, Locally Advanced or Metastatic NSCLC Patients with EGFR Exon 20 Insertion Mutations Inclusion Criteria
•Documented validated results from local testing of either tumor tissue or blood confirming the presence of EGFR Exon 20 insertion mutations, performed at a CLIA- or equivalently certified laboratory.

Exclusion Criteria

•Treatment with chemotherapy, targeted therapy, biologic therapy or an investigational agent as anti-cancer therapy within 3 or 3 elimination weeks or five half-lives prior to initiation of furmonertinib, whichever is shorter, or endocrine therapy within 2 weeks prior to initiation of furmonertinib.
•Radiation therapy as cancer therapy within 4 weeks prior to initiation of furmonertinib.
•Palliative radiation to bone metastases within 2 weeks prior to initiation of furmonertinib.
•AE from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia or Grade ≤ 2 peripheral neuropathy.
•Stage 2 Cohort 4 Untreated or Previously Treated EGFR TKI-Naïve, Locally Advanced or Metastatic NSCLC Patients with EGFR Uncommon Mutations Exclusion Criteria
•Prior treatment with any EGFR TKIs
•Progression during neoadjuvant or adjuvant therapy (e.g., chemotherapy, radiotherapy, immunotherapy or investigational agents) or within 12 months of completion of above therapies.

Arms & Interventions

Stage 1 Dose Escalation and Backfill

Experimental: Previously treated patients with advanced or metastatic NSCLC with activating EGFR or HER2 mutations