NCT03903705

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

A Phase Ib/II Study To Evaluate The Safety, Tolerability, Pharmacokinetic Profile And Preliminary Efficacy Of Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is composed of Fruquintinib plus sintilimab treatment arm and Fruquintinib monotherapy arm. Fruquintinib plus sintilimab treatment arm: * Dose escalation phase: it is planned to enroll about 26-39 patients * Dose expansion phase: it is planned to enroll about 309-329 patients, including about 140 patients with endometrial cancer Fruquintinib monotherapy arm: about 13 patients with advanced endometrial cancer

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Fruquintinib in Combination with Sintilimab	Fruquintinib plus Sintilimab: Cohort A: Fruquintinib 3 mg QD, oral dosing, 3 weeks on/1 weeks off +Sintilimab 200mg Q4W, intravenous dosing. Cohort B: Fruquintinib 4 mg QD, oral dosing, 3 weeks on/1 weeks off +Sintilimab 200mg Q4W, intravenous dosing Cohort C: Fruquintinib 5 mg QD, oral dosing, 2weeks on/1 weeks off + Sintilimab 200mg Q3W, intravenous dosing Cohort E: Fruquintinib 3 mg QD, continuous, oral dosing, + Sintilimab 200mg Q3W, intravenous dosing Fruquintinib monotherapy arm: Fruquintinib 5 mg QD, oral dosing, 3 weeks on/1 weeks off Patients will be treated until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria.

Timeline

• Start date: 2019-04-25
• Primary completion: 2023-11-15
• Completion: 2024-12-16
• First posted: 2019-04-04
• Last updated: 2025-04-06

Locations

1 site across 1 country: China