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This is an open-label, phase I study evaluating safety, tolerability, pharmacokinetics and efficacy of Surufatinib combined with the humanized anti-PD-1 antibody JS001 in patients with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surufatinib 200mg/JS001 240mg | Experimental | Surufatinib at a dose of 200mg Qd, with humanized anti-PD-1 monoclonal antibody(JS001) injected intravenously 240mg per 3 weeks until disease progresses or unacceptable tolerability occurs. |
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| Surufatinib 300mg/JS001 240mg | Experimental | Surufatinib at a dose of 300mg Qd, with humanized anti-PD-1 monoclonal antibody(JS001) injected intravenously 240mg per 3 weeks until disease progresses or unacceptable tolerability occurs. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib/humanized anti-PD-1 monoclonal antibody | Drug | humanized anti-PD-1 monoclonal antibody(JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with th combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activitation of lymphocytes and elimination of malignancy theoretically. |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Safety of participants followed for the duration of hospital stay, an expected average of 1 week | 1 year |
| Maximum tolerated dose | tolerability during the treatment of first cycle | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%). In the event of PR or CR, the subjects should confirm it no less than 4 weeks after the first evaluation. CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1(each cycle is 21 days)) | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen | Contact | 86-10-88196561 | linshenpku@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen, MD, PhD | Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35166929 | Derived | Cao Y, Lu M, Sun Y, Gong J, Li J, Lu Z, Li J, Zhang X, Li Y, Peng Z, Zhou J, Wang X, Shen L. Surufatinib plus toripalimab in patients with advanced solid tumors: a single-arm, open-label, phase 1 trial. J Cancer Res Clin Oncol. 2023 Feb;149(2):779-789. doi: 10.1007/s00432-021-03898-8. Epub 2022 Feb 15. |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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| time to treatment failure(TTF) | From date of enrollment until the date of tumor progression | 1 month |
| Maximum Plasma Concentration (Cmax) | Pharmacokinetic profile in terms of observed maximum plasma concentration | 8 days |
| Area Under the Curve From Time Zero Extrapolated to Infinity (AUC(0-inf)) | Pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity, AUC(0-inf) | 8 days |