Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Small Cell Lung Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Stomach Neoplasms

Sarcoma

Lung Neoplasms

Neuroendocrine Tumors

Thyroid Carcinoma, Anaplastic

Carcinoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplasms, Glandular and Epithelial

Small Cell Lung Cancer

Stomach Cancer

Soft Tissue Sarcoma

Neuroendocrine Tumor

Anaplastic Thyroid Cancer

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Tislelizumab

Antineoplastic Agents, Immunological

In Part 1 (dose escalation), surufatinib and will be administered orally (PO) once daily (QD) and tislelizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W).

In Part 2, the indication-specific expansion portion of the study, patients will receive surufatinib at the Recommended Phase 2 Dose (RP2D) dose selected in Part 1 with 200 mg tislelizumab IV, Q3W

Part 1 (all cohorts): oral surufatinib at a dose based on cohort level and intravenous tislelizumab at a 200-mg dose

Surufatinib and Tislelizumab _ Part 1

Part 2 (all cohorts): oral surufatinib at the RP2D dose selected in Part 1 and intravenous tislelizumab at a 200-mg dose

Surufatinib and Tislelizumab _ Part 2

John Kauh, MD

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).

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.

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

The primary outcome during dose escalation will be the incidence rate of dose limiting toxicities

The primary outcome of dose expansion will be objective response rate (ORR) in patients with advanced solid tumors when treated with surufatinib in combination with tislelizumab in each cohort

the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).

Blood samples will be taken to measure levels of study drug

Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

The incidence of complete response, partial response and stable disease

The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded

The incidence of partial response and stable disease

The period from the date of enrollment to the date when the criteria for complete response or partial response was first measured (first record shall prevail).

The period from date of enrollment to date of death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors	NCT04579757	Metastatic Soli... Colorectal Canc... Neuroendocrine ... Small Cell Lung... Gastric Cancer Soft Tissue Sar... Anaplastic Thyr...	Surufatinib and... Surufatinib and...	18 Years -	Hutchmed
Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors	NCT04579757	Metastatic Soli... Colorectal Canc... Neuroendocrine ... Small Cell Lung... Gastric Cancer Soft Tissue Sar... Anaplastic Thyr...	Surufatinib and... Surufatinib and...	18 Years -	Hutchmed

Spots Global Cancer Trial Database for surufatinib and tislelizumab part 1