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Association details:
| Biomarker: | FGF19 overexpression |
|---|---|
| Cancer: | Hepatocellular Cancer |
| Drug: | irpagratinib (ABSK011) (FGFR4 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab in HCC Patients
Excerpt:
...Incidence of dose limiting toxicity (DLT) in the first cycle；Incidence and grade of AE, SAE and AESI by CTCAE v5.0`To evaluate the safety and tolerability of ABSK-011 combined with atezolizumab mab in subjects with advanced or unresectable HCC`Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed`To evaluate the objective response rate of ABSK-011 combined with atezolizumab in subjects with advanced FGF19 overexpression or unresectable HCC...
Trial ID:
Source:
Title:
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor
Excerpt:
...Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing...
Trial ID:
Less C2 evidence
Source:
Title:
1012P - First-in-human study of ABSK-011, a novel, highly selective fibroblast growth factor receptor (FGFR) 4 inhibitor for treating advanced hepatocellular carcinoma (HCC) with FGF19 overexpression
Published date:
10/16/2023
Excerpt:
One complete response (CR) and 12 partial responses were reported by investigator assessment per RECIST 1.1 (including unconfirmed) among the 65 evaluable HCC pts with prior therapies….BID dosing showed encouraging efficacy with an overall response rate (ORR) of 43.5% (10/23, 1 CR), including 6 responders in 160 mg BID (6/18, 33.3%) and 4 in 220 mg BID (4/5, 80.0%)....The promising response rate and manageable safety profile from this phase I study suggest that ABSK-011 may have clinical benefit for HCC pts with prior therapies through biomarker selection of FGF19.
Trial ID:
