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

PHASE2RecruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

November 25, 2024

Primary Completion Date

December 30, 2027

Study Completion Date

June 30, 2028

Conditions
Non-Small Cell Lung Cancer With EGFR Mutation
Interventions
DRUG

ABSK043 in combination with Firmonertinib

"Two potential dose levels :400 mg twice daily (BID) and 800 mg BID) of ABSK043 are prespecified and firmonertinib will be administered orally at a fixed dose of 80 mg once daily (QD).~Patients in dose escalation cohort will receive the ABSK043, 400 mg BID and firmonertinib 80 mg QD as the starting dose for the combination therapy.~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.~After Cycle 1, 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 (5)

Unknown

NOT_YET_RECRUITING

Hanhui Cancer Hospital, Hefei

NOT_YET_RECRUITING

Harbin Medical University Cancer Hospital, Harbin

NOT_YET_RECRUITING

Union Hospital Tongji Medical College Huzhong University of Science and Techology, Wuhan

NOT_YET_RECRUITING

Jilin Cancer Hospital, Changchun

RECRUITING

Shanghai Chest Hospital, Shanghai

Sponsors
All Listed Sponsors
lead

Abbisko Therapeutics Co, Ltd

INDUSTRY