Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
Colon/Rectal Cancer
Lung Cancer
Neuroendocrine Tumor
Sarcoma
Stomach/ Gastric Cancer
18 Years and older, Male and Female
2020-012-GLOB1 (primary)
NCI-2021-01887
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).
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.
Eligibility
- 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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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