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
Patients must have the a central laboratory or previous test report confirming FGFR2/3 gene activatingon alterations (including FGFR2/3 activating mutations, fusions/rearrangements, or FGFR2 amplifications) or overexpression in tumor tissue or blood based on central laboratory test or previous test reports.
Cohort 1 (HER2-gastric/gastroesophageal junction cancer)
Histologically or cytologically confirmed metastatic/unresectable gastric/gastroesophageal junction cancer, HER2 test negative
The patient had FGFR2 amplification or overexpression in tumor tissue confirmed by a central laboratory test or a previous test report (previous test report only applied to FGFR2 amplification)
Previous treatment with an FGFR pathway inhibitor or a multi-kinase inhibitor designed to inhibit FGFR (consultation with the sponsor is recommended)
Active or medical history of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. (Patients with type 1 diabetes mellitus, hypothyroidism requiring hormone replacement therapy only, skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are allowed.Uncertain autoimmune-related status should be discussed with the sponsor).
The patient had clinically symptomatic lung disease (e.g. interstitial pneumonia, pulmonary fibrosis, severe radiation pneumonitis, etc.) requiring systemic corticosteroid therapy within 6 months prior to enrollment.
Known other malignancies that are in progression or require active treatment (except cured skin cancer, carcinoma in situ of the cervix, basal cell carcinoma, focal prostate cancer with a Gleason score of 6, focal prostate cancer with a Gleason score of 3 + 4 and treated for more than 6 months at screening).
Parallel
ABSK061 + ABSK043
DrugParticipants 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.
ABSK061+ABSK043 in combination with CAPOX
DrugParticipants 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.
Incidence of Dose limited toxicity (DLT)
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
To assess the tolerability of ABSK061 + ABSK043 in combination with CAPOX in patients with first-line gastric/gastroesophageal junction cancer
Number of Participants With Adverse Event (AE), Serious Adverse Event, (SAE) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT)
To assess the anti-tumor activity of ABSK061 + ABSK043 in combination with CAPOX as the primary endpoint of Progression-free survival (PFS) in first-line treatment of patients with metastatic/unresectable HER2-gastric/gastroesophageal junction cancer
PFS, as assessed by the investigator per RECIST v1.1
To assess the anti-tumor activity of ABSK061 + ABSK043 in patients with metastatic/unresectable urothelial cancer with FGFR2/3 activating alteration or FGFR3 overexpression, with Objective response rate (ORR) as the primary endpoint
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Overall Response Rate as Assessed by Investigator
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Duration of Response (DOR)
DOR is the duration from the date of initial documentation of a response to the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study), or death, whichever comes first.
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with CR, PR or stable disease (SD).DCR is defined as the percentage of participants with CR, PR or stable disease (SD).
Progression Free Survival (PFS)
PFS is the duration from the date of the first dose of study drug until the date of first documented evidence of progressive disease (or relapse for participants who experience CR during the study) or death, whichever comes first.
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