A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

October 25, 2025

Primary Completion Date

December 30, 2028

Study Completion Date

July 30, 2029

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

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."

Trial Locations (17)

Unknown

The First Affiliated Hospital of Anhui Medical University, Hefei

Beijing Cancer Hospital, Beijing

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

Fujian Cancer Hospital, Fuzhou

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou

Guangxi Medical University Cancer Hospital & Guangxi Cancer Institude, Nanning

Harbin Medical University Cancer Hospital, Harbin

Henan Cancer Hospital, Zhengzhou

Tongji Hospital Tongji Medical College of Hust, Wuhan

Hunan Cancer Hospitial, Changsha

Zhongda Hospital Southeast University, Nanjing

The First Hospital of China Medical University, Shenyang

Central Hospital Affiliated to Shangdong First Medical University, Jinan

Shanghai Chest Hospital, Shanghai

Shanghai Pulmonary Hospital, Shanghai

The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an

West China Hospital Sichuan University, Chengdu

Sponsors
All Listed Sponsors
lead

Abbisko Therapeutics Co, Ltd

INDUSTRY

NCT07164170 - A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib | Biotech Hunter | Biotech Hunter