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Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors

NCT04579757 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-05-08

Study results available
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Summary

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Hutchmed

    lead INDUSTRY

Principal Investigators

  • William Schelman, MD · Hutchmed

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-05
Primary Completion
2024-04-30
Completion
2024-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04579757 on ClinicalTrials.gov