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fruquintinib+sintilimab

Phase 3

Advanced Renal Cell Carcinoma | Small molecule | Oncology |HUTCHMED (China) Limited|Last Updated: Jan 2, 2025

Target and mechanism

Molecular targetFLT1, FLT4, KDR
Target classInhibitor
ModalitySmall molecule

Also known as fruquintinib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment265

FDA Designations

PRIORITY_REVIEWBREAKTHROUGH_THERAPY

Clinical trial landscape

fruquintinib+sintilimab · 1 trial · 1 indication

Phase 2/3 1
NCT05522231Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)Advanced Renal Cell Carcinoma
ACTIVE NOT_RECRUITING265 Analytics
PHASE2/PHASE3ACTIVE NOT_RECRUITING
Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)
Advanced Renal Cell CarcinomaUnlock trial analytics

Study Design & Arms

Interventions

NameTypeDescription
fruquintinib+sintilimabDRUGfruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
axitinib / everolimusDRUGaxitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion based on clinical; everolimus, 10 mg, QD, PO, 3 weeks/cycle.
fruquintinibDRUGfruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
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Frequently asked questions about fruquintinib+sintilimab

What is Fruquintinib used for?

Fruquintinib is an investigational small molecule kinase inhibitor being developed for oncology indications including colorectal cancer, gastric cancer, advanced renal cell carcinoma, and metastatic colorectal cancer. It is also being studied for drug-drug interactions and food effects in healthy subjects. The drug is not FDA approved and remains in clinical development.

How does Fruquintinib work?

Fruquintinib is a small molecule kinase inhibitor, belonging to the -tinib class of targeted therapies. It works by inhibiting kinase enzymes involved in tumor growth and angiogenesis. The drug is being studied across multiple cancer types, including colorectal and gastric cancers, where kinase signaling pathways are frequently dysregulated.

Who is developing Fruquintinib?

Fruquintinib is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed under the ticker HCM. The company is conducting clinical trials of the drug primarily in China across multiple oncology indications, including colorectal cancer and gastric cancer.

What phase is Fruquintinib in?

Fruquintinib is in Phase 1 clinical development, though completed trials have included Phase 2 and Phase 3 studies. The drug has received FDA designations of Priority Review and Breakthrough Therapy. It remains investigational and is not yet FDA approved for any indication.

What clinical trials is Fruquintinib in?

Fruquintinib has been studied in several clinical trials, including NCT01975077 (Phase Ib in 3rd line metastatic colorectal cancer), NCT02196688 (Phase 2 in metastatic colorectal cancer), NCT02314819 (Phase 3 FRESCO trial in 3+ line colorectal cancer), and NCT03223376 (Phase 3 FRUTIGA trial in second line gastric cancer). These trials have been completed.

Is Fruquintinib the same as any other drug?

Fruquintinib is known by its generic name and does not have alternative names listed in the available data. It is a distinct small molecule kinase inhibitor being developed by HUTCHMED for multiple oncology indications, including colorectal cancer and gastric cancer.