NCT06632262

A Phase 2 Clinical Study of ABSK061 and ABSK043

An Open-label Phase 2, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Efficacy of ABSK061 and ABSK043 with or Without Chemotherapy in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the anti-tumor activity of ABSK061 + ABSK043 in terms of overall response rate (ORR) in in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations

Detailed description

ABSK061 is a selective and potent pan FGFR 2/3 inhibitor with demonstrated clinical activity in participants with a variety of FGFR inhibitors in a variety of solid tumors. ABSK043 is a small molecule PD-L1 inhibitor with good oral bioavailability, high selectivity and high activity, and is currently being developed for the treatment of multiple cancers and potential non-oncology indications. This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype. The study consists of screening phase, treatment phase and the post treatment follow-up phase (from the end of treatment visit until the participant has died, withdraws consent, is lost to follow-up, or the end of study, whichever comes first). End of study is considered of the last visit of the last patient in this trial or the procedures shown in the schedule, or 12 months after the first dose of the last enrolled patient, whichever occurs first.

Conditions

• HER2-Gastric/Gastroesophageal Junction Cancer
• Urothelial Carcinoma
• Non-Small Cell Lung Cancer
• Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-13
• Primary completion: 2029-11-30
• Completion: 2030-06-30
• First posted: 2024-10-09
• Last updated: 2024-11-19

Locations

21 sites across 1 country: China