Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04579757|
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : April 4, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Solid Tumor Colorectal Cancer Neuroendocrine Tumors Small Cell Lung Cancer Gastric Cancer Soft Tissue Sarcoma Anaplastic Thyroid Cancer||Drug: Surufatinib and Tislelizumab _ Part 1 Drug: Surufatinib and Tislelizumab _ Part 2||Phase 1 Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase Ib/II Study of Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors|
|Actual Study Start Date :||March 5, 2021|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||June 30, 2024|
Experimental: Surufatinib and tislelizumab (dose escalation_Part 1)
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).
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
Other Name: HMPL-012, sulfatinib, BGB-A317
Experimental: Surufatinib and tislelizumab (indication specific_Part 2)
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
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
Other Name: HMPL-012, sulfatinib, BGB-A317
- Incidence of dose limiting toxicity [ Time Frame: up to 60 days ]The primary outcome during dose escalation will be the incidence rate of dose limiting toxicities
- Objective response rate (ORR) [ Time Frame: up to 2 years ]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
- Progression Free Survival (PFS) [ Time Frame: up to 6 months ]the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
- Maximum plasma concentrations of surufatinib and tislelizumab with blood sampling [ Time Frame: up to 18 months ]Blood samples will be taken to measure levels of study drug
- To evaluate the safety, in subjects, treated with surufatinib and tislelizumab [ Time Frame: up to 2 years ]Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
- Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]The incidence of complete response, partial response and stable disease
- Duration of Response (DoR) [ Time Frame: up to 24 months ]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
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 24 months ]The incidence of partial response and stable disease
- Time to Response (TTR) [ Time Frame: up to 24 months ]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).
- Overall Survival [ Time Frame: up to 36 months ]The period from date of enrollment to date of death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579757
|Contact: Leslie Callahanemail@example.com|
|Contact: Chris Tucci||973-786-2634||Christucci@hutch-med.com|
|Study Director:||John Kauh, MD||Hutchison|