Spots Global Cancer Trial Database for A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients

Study Description

Brief 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 a multi-center, open-label, Phase 1b study evaluating the adverse events and best dose of the combination of fixed dose AZD9291 with APG-1252 in EGFR-TKI resistant NSCLC patients. In exploration phase, 3+3 design will be used to determine the MTD/RP2D of the combination of AZD9291 with APG-1252; Dose of AZD9291 will be fixed at 80mg QD, APG-1252 will start with 240mg weekly, then escalate to 320mg weekly and 400mg weekly or decline to 160mg weekly and 80weekly if not tolerate to 240mg weekly dosage. In expansion phase, IF 1 confirmed PR or CR observed in NSCLC patients who failed 3rd generation EGFR TKI, the exploration of the combination of AZD9291 with APG-1252 in 3rd generation EGFR TKI naïve NSCLC patients will be initiated. After completing the enrollment of these two cohorts, a new cohort was added: to explore the preliminary efficacy of APG-1252 combined with osimertinib in the treatment of EGFR Exon20 Insertion or other rare mutant NSCLC patients, and enroll 20 subjects. Patients will be treated in 21-day cycles. APG-1252 administered via intravenous infusion for 30 minutes weekly (,Day 1, 8 15), AZD9291 via oral daily with 80mg.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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