A Phase 2 Clinical Study of ABSK061 and ABSK043

PHASE2RecruitingINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

November 13, 2024

Primary Completion Date

November 30, 2029

Study Completion Date

June 30, 2030

Conditions
HER2-Gastric/Gastroesophageal Junction CancerUrothelial CarcinomaNon-Small Cell Lung CancerSolid Tumors
Interventions
DRUG

ABSK061 + ABSK043

Participants with fibroblast growth factor receptor (FGFR) mutations and FGFR gene fusions will receive a dose of ABSK061 + ABSK043 oral capsule until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.

DRUG

ABSK061+ABSK043 in combination with CAPOX

Participants with HER2-Gastric/Gastroesophageal Junction Cancer and fibroblast growth factor receptor 2( FGFR2 ) amplification and overexpression will receive a dose of ABSK061 + ABSK043 oral capsule in combination with CAPOX until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment, or end of data collection timepoint if there is clinical benefit in the opinion of the investigator, has been achieved.

Trial Locations (21)

110000

NOT_YET_RECRUITING

Liaoning Cancer Hospital and Institute, Shenyang

150000

NOT_YET_RECRUITING

Harbin Medical University Cancer Hospital, Harbin

200000

RECRUITING

ZhongShan Hospital Fudan University, Shanghai

250000

NOT_YET_RECRUITING

Cancer Hospital of Shandong First Medical University, Jinan

330000

NOT_YET_RECRUITING

Jiangxi Cance Hospital, Nanchang

410000

NOT_YET_RECRUITING

Hunan Central Hospital, Changsha

450000

NOT_YET_RECRUITING

Henan Cancer Hospital, Zhengzhou

550000

NOT_YET_RECRUITING

Guizhou Provincial People'S Hospital, Guiyang

NOT_YET_RECRUITING

The Affiliated Hospital of Guizhou Medical University, Guiyang

610000

NOT_YET_RECRUITING

Xiangyang Central Hospital, Xiangyang

050000

NOT_YET_RECRUITING

The Fourth Hospital of Hebei Medical University, Shijiazhuang

Unknown

NOT_YET_RECRUITING

Changzhi People's Hospital, Changzhi

NOT_YET_RECRUITING

West China Hospital, Sichuan University, Chengdu

NOT_YET_RECRUITING

The First Hospital of China Medical University, Hangzhou

NOT_YET_RECRUITING

Zhejiang Provincial People'S Hospital, Hangzhou

NOT_YET_RECRUITING

Tianjin Medical University Cancer Institute and Hospital, Tianjin

NOT_YET_RECRUITING

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan

NOT_YET_RECRUITING

First Hospital of Shanxi Medical University, Xi'an

NOT_YET_RECRUITING

Shanxi Cancer hospital (Shanxi Cancer institute), Xi'an

NOT_YET_RECRUITING

First Affiliated Hospital of Xiamen University, Xiamen

NOT_YET_RECRUITING

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

Sponsors
All Listed Sponsors
lead

Abbisko Therapeutics Co, Ltd

INDUSTRY