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.

Fruquintinib in Combination with Sintilimab

Panfeng Tan, MD

Yan Jiang

Jing Li, Doctor

Jin Li

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.

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

Open-Label Phase 1b/II Study of Fruquintinib in Combination with Sintilimab to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy in Patients with Advanced Solid Tumor.

: 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

Evaluate the potential biomarkers related to the antitumor effect of fruquintinib plus sintilimab.

Dose escalation phase: To evaluate the safety and tolerability of fruquintinib plus sintilimab for advanced solid tumors in the dose escalation phase, to observe dose-limiting toxicity (DLT), the maximum tolerated dose (MTD) and/or to determine the recommended phase 2 dose (RP2D) and administration strategy of the combination therapy.

Dose expansion phase (except endometrial cancer \[EMC\] cohort): ORR assessed by investigator

Dose expansion phase (EMC cohort): ORR by IRC

Fruquintinib monotherapy arm: ORR by investigator

Immunogenicity Assessments for Anti-drug Antibody(ADA)

To evaluate the PK profile of fruquintinib plus sintilimab

Dose expansion phase (except EMC cohort): DCR, PFS, OS, DoR, TTR by investigator

Dose expansion phase (EMC cohort): ORR, DCR, PFS, OS, DoR, TTR by investigator

Dose expansion phase (EMC cohort): DCR, PFS, OS, DoR, TTR by IRC

Overall incidence of AEs, incidence of Grade ≥ 3 AEs, etc.

Detect the expression of PD-L1 and/or other biomarkers in tumor tissues of patients, and analyze the relevant efficacy to provide reference for determining the dominant population.

Spots Global Cancer Trial Database for : A Phase Ib/II Study To Evaluate Fruquintinib Monotherapy Or Plus Sintilimab In Advanced Solid Tumors

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