Trials / Terminated

TerminatedNCT04579757

Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors

An Open-Label Phase Ib/II Study of Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors

Status: Terminated
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 87 (actual)

Sponsor: Hutchmed · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

Detailed description

This open-label, phase Ib/II study of surufatinib in combination with tislelizumab will evaluate the safety, tolerability, PK and efficacy in patients with advanced solid tumors. The study consists of 2 parts - dose finding (Part 1) and dose expansion (Part 2). Part 1 will be conducted to determine the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD) of surufatinib in combination with tislelizumab in patients with advanced or metastatic solid tumors who have progressed on, or are intolerant to standard therapies. Part 2 will be an open-label, multi-cohort design to evaluate the anti-tumor activity of surufatinib in combination with tislelizumab in patients with specific types of advanced or metastatic solid tumors. Patients will receive the RP2D determined in part 1 of this study.

Conditions

Interventions

Type	Name	Description
DRUG	Surufatinib and Tislelizumab _ Part 1	Part 1 (all cohorts): oral surufatinib at a dose based on cohort level and intravenous tislelizumab at a 200-mg dose
DRUG	Surufatinib and Tislelizumab _ Part 2	Part 2 (all cohorts): oral surufatinib at the RP2D dose selected in Part 1 and intravenous tislelizumab at a 200-mg dose

Timeline

Start date: 2021-03-05
Primary completion: 2024-04-30
Completion: 2024-08-27
First posted: 2020-10-08
Last updated: 2025-05-08
Results posted: 2025-05-08

Locations

18 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04579757. Inclusion in this directory is not an endorsement.