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This study is a one-arm, open, multicenter phase 1b/2 clinical trial of YL-13027 combined with Sintilimab in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.Sintilimab is administered as a fixed-dose intravenous injection(200mgQ3w).
Part 1 (Phase Ib):
This is a dose escalation,3+3 design study, to evaluate the safety and tolerability, and to determine the RP2D of YL-13027 when administered b.i.d. in patients with advanced solid tumors. One cycle is 21 days.
Part 2 (Phase II):
This is an expansion phase in patients with advantage advanced solid tumors to further evaluate the safety, tolerability and preliminary anti-tumor activity of YL-13027 at the RP2D combined with Sintilimab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YL-13027+Sintilimab | Experimental | YL-13027 tablets will be given daily for 21 days in 21-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the patient discontinues from the study treatment for other reasons. Sindilizumab injection will be given 200mg every three weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL-13027,Sintilimab | Drug | YL-13027 combined with Sintilimab will be used as a cycle for 21 days. YLl-13027 is administered orally twice a day. Starting dose of YL-13027 is 240mg/d,with escalation to 360mg/d in phase Ib, and RP2D was administered orally twice a day in phase II. Sindilizumab is administered intravenously 200mg every three weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Adverse events evaluated by NCI CTCAE v5.0 | from the first dose to within 30 days after the last dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | One of Pharmacokinetic (PK) parameters. | within 42 days after the first dose |
| Time to maximum concentration (Tmax) | One of Pharmacokinetic (PK) parameters. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanying Bao, PhD | Contact | 86 21-51370693 | hybao@yl-pharma.com | |
| Wenxiang Xu | Contact | 86 21-51320088 | 8588 | wxxu@yl-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Hanying Bao, PhD | Shanghai YingLi Pharmaceutical Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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YL-13027 combined with Sintilimab was used as a cycle for 21 days.
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| within 42 days after the first dose |
| Area under the curve (AUC) | One of Pharmacokinetic (PK) parameters. | within 42 days after the first dose |
| Half-life (t1/2) | One of Pharmacokinetic (PK) parameters. | within 42 days after the first dose |
| Clearance (CL) | One of Pharmacokinetic (PK) parameters. | within 42 days after the first dose |
| Objective response rate | the proportion of patients who have a Complete Response or Partial Response | From the first dose to the date of disease progression or date of death from any cause, whichever comes first,up to 24months. |
| Disease control rate | the proportion of patients who have a Complete Response, Partial Response or Stable disease. | From the first dose to the date of disease progression or date of death from any cause, whichever comes first,up to 24months. |