Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Metastatic Solid Tumor, Colorectal Cancer, Neuroendocrine Tumors, Small Cell Lung Cancer, Gastric Cancer, Soft Tissue Sarcoma, Anaplastic Thyroid Cancer

In brief

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).

Key facts

Study ID

NCT04579757

Run by

Hutchmed

People needed

87

Starts

2021-03-05

Expected to finish

2024-08-27

Last updated by the study team

2025-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide informed consent
• ≥18 years of age
• Part 1-have evaluable lesions (according to Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1])
• Part 2-have measurable lesions (according to RECIST v1.1)
• Have a performance status of 0 or 1 on the ECOG scale
• For female subjects of childbearing potential and male patients with partners of childbearing potential, agreement to use a highly effective form(s) of contraception
• Dose Escalation:
• Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type,.
• Dose Expansion:
• Histologically or cytologically documented, locally advanced or metastatic:
• Cohort A: adenocarcinoma of the colon or rectum that is microsatellite stable. Subjects must have progressed on, or had intolerable toxicity to, at least 3 prior regimens of standard chemotherapy.
• Cohort B: progressive, low or intermediate grade (grade 1 or grade 2) NETs of thoracic or GEP origins. Subjects must have radiological documentation of progression of disease in the last 6 months and must have progressed on at least one line of standard therapy for metastatic disease.
• Cohort C: SCLC that has progressed on standard first line chemotherapy treatment.
• Cohort D: adenocarcinoma of the stomach or gastroesophageal junction and have progressed on at least 2 prior lines of therapy. Tumor stain for PD-L1 by Combined Positive Score (CPS) ≥5%.
• Cohort E: ASPS or UPS. Subjects must have radiological documentation of disease progression in the last 3 months and have progressed on at least one line of standard therapy or refused standard frontline cytotoxic chemotherapy.
• Cohort F: Anaplastic thyroid cancer that is considered not curable by resection. Patients with a BRAFV600E mutation must have previously been treated with 1 line of systemic therapy with a BRAF-targeted therapy.

You may not qualify if…

• Adverse events (AEs) due to previous anti-tumor therapy has not recovered to Common Terminology Criteria for Adverse Event (CTCAE) ≤Grade 1;
• Part 2 subjects with CRC , NETs and STS any previous treatment with anti-PD-1, anti PD-L1/L2 antibodies, anti-cytotoxic T lymphocyte associated antigen-4 (CTLA-4) antibody, or any other antibody acting on T cell costimulatory or checkpoint pathway;
• Previous treatment with surufatinib;
• Uncontrollable hypertension;
• History or presence of a serious hemorrhage (>30 ml within 3 months), hemoptysis (>5 ml blood within 4 weeks) or life threatening thromboembolic event within 6 months;
• Clinically significant cardiovascular disease;
• Any clinically significant active infection, including, but not limited to, known human immunodeficiency virus (HIV) infection;
• Brain metastases and/or leptomeningeal disease and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of SD for 14 days or longer; subjects requiring steroids within 4 weeks prior to start of study treatment will be excluded;
• Active autoimmune diseases or history of autoimmune diseases that may relapse with the following exceptions:
• Controlled Type 1 diabetes
• Hypothyroidism (provided it is managed with hormone-replacement therapy only)
• Controlled celiac disease
• Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
• Any other disease that is not expected to recur in the absence of external triggering factors.
• Arterial thrombosis or thromboembolic events (including stroke and/or transient ischemic attack) within 12 months prior to first dosing;
• History of deep venous thrombosis within 6 months;
• Female patients who are pregnant or breastfeeding;
• Any condition by which investigators judge patients not suitable to participate in this study.

Where it is running

• Arizona Oncology Associated, PC-HOPE — Tucson, Arizona, United States
• City of Hope — Duarte, California, United States
• Rocky Mountain Cancer Centers Midtown — Denver, Colorado, United States
• Johns Hopkins University - Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Emory University - Winship Cancer Institute — Atlanta, Georgia, United States
• Holden Comprehensive Cancer Center, University of Iowa — Iowa City, Iowa, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• University of Pennsylvania, Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
• Prisma Health - Upstate (ITOR) — Greenville, South Carolina, United States
• Sarah Cannon — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Mary Crowley Cancer Research — Dallas, Texas, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology, P.A. — Fort Worth, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Texas Oncology, P.A. — Tyler, Texas, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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