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A Phase 2 Study of ABSK043 Combined With Osimertinib
Sponsor: Abbisko Therapeutics Co, Ltd
Summary
This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer
Official title: A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Osimertinib in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2026-08-31
Completion Date
2030-12-31
Last Updated
2026-07-17
Healthy Volunteers
No
Interventions
ABSK043 in combination with Osimertinib
Three potential dose levels of ABSK043 are prespecified, and Osimertinib will be administered orally at a fixed dose of 80 mg QD in escalation cohort. Patients in dose confirmation cohort and dose expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity of the combination therapy.
Locations (7)
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China