drugset / Trial / NCT04001777
A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients
Phase 1
Active not recruiting
80 enrolled
Ascentage Pharma Group Inc.
Suzhou Yasheng Pharmaceutical Co., Ltd. · collab
NaSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2019-07-04
- Primary completion
- 2025-12
- Completion
- 2026-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Osimertinib | Small molecule | 40 mg | Oral |
| Subject | Osimertinib | Small molecule | 80 mg | Oral |
| Subject | Pelcitoclax | Small molecule | 80 mg | Intravenous |
| Subject | Pelcitoclax | Small molecule | 160 mg | Intravenous |
| Subject | Pelcitoclax | Small molecule | 240 mg | Intravenous |
| Subject | Pelcitoclax | Small molecule | 320 mg | Intravenous |
| Subject | Pelcitoclax | Small molecule | 400 mg | Intravenous |