Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors (NCT04579757) | Clinical Trial Compass
TerminatedPhase 1/2
Surufatinib in Combination With Tislelizumab in Subjects With Advanced Solid Tumors
Stopped: Study terminated by sponsor
United States87 participantsStarted 2021-03-05
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type,.
✓. Histologically or cytologically documented, locally advanced or metastatic:
Exclusion criteria
✕. 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;
What they're measuring
1
Dose Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs)
Timeframe: From the first dose of study drug (Day 1) up to Day 21 of Cycle 1 (cycle duration: 3 weeks)
2
Dose Escalation Phase: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
Timeframe: From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 9 months
Timeframe: Tumor assessments performed every 6 weeks (+/-1 week) for the first 24 weeks and every 9 weeks (+/-1 week) thereafter, up to a maximum of approximately 37 months
✕. 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;
✕. 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;