Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors

Active:	No
Cancer Type:	Colon/Rectal Cancer Lung Cancer Neuroendocrine Tumor Sarcoma Stomach/ Gastric Cancer	NCT ID:	NCT04579757
Trial Phases:	Phase I Phase II	Protocol IDs:	2020-012-GLOB1 (primary) NCI-2021-01887
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hutchmed
NCI Full Details:	http://clinicaltrials.gov/show/NCT04579757

Summary

Objectives

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.

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