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

Sponsor
Ascentage Pharma Group Inc.
Study ID
NCT04001777
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • EGFR Positive Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 4, 2019
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: APG-1252 plus Osimertinib (AZD9291)
    APG-1252 will be explored sequentially using a standard 3+3 escalation scheme at the dose escalation phase; Dose of osimertinib will be fixed at 80mg QD based on approved label.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: 21 days ]

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