At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Fruquintinib in Combination with Sintilimab for Advanced Solid Tumor. Completed, enrolled 348 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.