: A Phase Ib/II Study To Evaluate Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors

Summary

This is a phase Ib/II study to evaluate the safety, tolerability, PK profile and preliminary efficacy of fruquintinib monotherapy or plus sintilimab for advanced solid tumors. This study includes fruquintinib plus sintilimab treatment arm (dose escalation phase and dose expansion phase), and fruquintinib monotherapy arm.

Timeline

Start

2019-04-25

Primary completion

2023-11-15

Completion

2024-12-16

Publications

• Wu X, Wang J, Wang D, Li G, Zhang J, Chen H, Yang H, Zhou Q, Wang K, Wu Y, Yi T, Liu J, Huang Y, Bai Y, Wang K, Jiang K, Lou H, An R, Li X, Pan Y, Wang Y, Tao W, Song K, Kang Y, Li Y, Shi W, Liu A, Yang Y, Wang Y, Chen K, Shi H, Lu P, Tan P, Fan S, Shi M, Su W. Fruquintinib plus sintilimab in patients with advanced endometrial cancer with mismatch-repair proficient status: a multicenter, single-arm, phase Ib/II trial. Nat Commun. 2025 Dec 21;17(1):658. doi: 10.1038/s41467-025-67375-3.
• Xu H, Yao X, He Z, Luo H, Li G, Guo J, Diao L, Fan Y, Li Y, Fan J, Hu X, Lu P, Shi H, Chen K, Tan P, Fan S, Shi M, Su W, Ye D. Fruquintinib Plus Sintilimab in Patients with Treatment-Naive and Previously Treated Advanced Renal Cell Carcinoma: Results from a Phase Ib/II Clinical Trial. Target Oncol. 2025 Jan;20(1):113-125. doi: 10.1007/s11523-024-01120-6. Epub 2025 Jan 13.
• Guo Y, Zhang W, Ying J, Zhang Y, Pan Y, Qiu W, Fan Q, Xu Q, Ma Y, Wang G, Guo J, Su W, Fan S, Tan P, Wang Y, Luo Y, Zhou H, Li J. Phase 1b/2 trial of fruquintinib plus sintilimab in treating advanced solid tumours: The dose-escalation and metastatic colorectal cancer cohort in the dose-expansion phases. Eur J Cancer. 2023 Mar;181:26-37. doi: 10.1016/j.ejca.2022.12.004. Epub 2022 Dec 13.

Drugs

Indications