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A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib
Sponsor: Abbisko Therapeutics Co, Ltd
Summary
This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle.
Official title: An Open-label Phase II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ABSK043 in Combination With Glecirasib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring a KRAS G12C Mutation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2025-10-25
Completion Date
2029-07-30
Last Updated
2025-09-10
Healthy Volunteers
No
Conditions
Interventions
ABSK043 in combination with Glecirasib
Dose escalation cohort( Part A) ABSK043 150 mg BID in combination with Glecirasib 200 mg QD will be selected as the starting dose. Based on the accumulated safety data and PK profile, the Safety Review Committee (SRC), composed of the investigator and the sponsor, may discuss and agree to allow exploration of other possible doses. Dose confirmation cohort (Part B) and Expansion cohort Patients in dose confirmation cohort and expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity. All patients will continue to receive combination therapy every 21 days until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator decision to discontinue treatment, or end of the study.
Locations (17)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institude
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, China
Hunan Cancer Hospitial
Changsha, Hunan, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Central Hospital Affiliated to Shangdong First Medical University
Jinan, Shangdong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China