NCT04001777

A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients

A Phase Ib Study of Safety and Efficacy of APG-1252 in Combination With Osimertinib (AZD9291) in EGFR TKI Resistant NSCLC Patients

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There are unmet medical needs in patients who resist to EGFR TKIs, especially to osimertinib; APG-1252 shows synergy with osimertinib in both osimertinib treatment naïve and resistant cell lines. This study is to explore the safety and efficacy of the combination of APG-1252 and osimertinib in 3rd generation TKI resistant patients and 3rd generation TKI treatment naïve patients.

Detailed description

This is an open-label, single-arm, multicenter, phase 1b study and consists of two stages: dose finding and dose expansion. The dose-finding stage will explore the safety and tolerability of APG-1252 at different dose levels combined with osimertinib mesylate tablets (hereinafter referred to as osimertinib) at a fixed dose level and determine the MTD and/or RP2D of APG-1252. According to the results from the ongoing phase 1 clinical trials (APG-1252-US-001, APG-1252-AU-001, APG-1252-CH-001) of APG-1252 currently, the starting dose of APG-1252 is set as 240 mg in the study. The 3+3 design will be implemented. The dose for successive cohorts will be escalated to 320 mg and 400 mg or de-escalated to 160 mg and 80 mg based on the safety of the starting dose. During the dose-expansion period, the efficacy of APG-1252 combined with osimertinib will first be studied in patients with NSCLC that has progressed after treatment with third-generation EGFR TKIs. There will be a total of 20 subjects in Cohort 1. If at least one of the first 10 evaluable patients achieves a response (confirmed complete response \[CR\] or partial response \[PR\], assessed by the investigator as per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) in the dose-expansion period, Cohort 2 and Cohort 3 will be initiated at the same time.

Conditions

• EGFR Positive Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	APG-1252	Multiple dose cohorts, 30 minute IV infusion, weekly for 3 weeks of a cycle with 21days.
DRUG	Osimertinib Mesylate Tablets	Osimertinib Mesylate Tablets 40mg/80 mg, one time a day until disease progression

Timeline

• Start date: 2019-07-04
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2019-06-28
• Last updated: 2025-10-01

Locations

4 sites across 1 country: China