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Association details:
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
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Title:

Phase 2 Study of HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma

Excerpt:
...Patients with histologically or cytologically confirmed locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements; 4....
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A phase 2 study of HMPL-453, a selective FGFR tyrosine kinase inhibitor (TKI), in patients with previously treated advanced cholangiocarcinoma containing FGFR2 fusions.

Published date:
05/25/2023
Excerpt:
Pts with histologically or cytologically confirmed locally advanced or metastatic iCCA with FGFR2 fusions...Of 22 evaluable pts...the best overall response by investigator assessment was confirmed partial response in seven (31.8%) pts and stable disease in an additional 12 pts (54.5%), resulting in a disease control rate (DCR) of 86.4%. Specifically, in cohort 2 the confirmed ORR was 50% (95% CI, 18.7%–81.3%) and DCR was 90% (95% CI, 55.5%–99.7%)...HMPL-453 showed promising efficacy, particularly in RP2D regimen (300 mg, QD, 2w on/1w off) and acceptable toxicity in pts with previously-treated advanced iCCA and FGFR fusions.
DOI:
10.1200/JCO.2023.41.16_suppl.e16118
Trial ID: