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This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI110 in subjects with advanced malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ia Dose-Escalation Stage:IBI110 | Experimental | Participants will be treated with escalating doses of IBI110 to determine the MTD. |
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| Phase Ia Expansion Stage:IBI110 | Experimental | Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in different cancer types. |
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| Phase Ib Dose-Escalation Stage:IBI110+ Sintilimab | Experimental | Participants will be treated with escalating doses of IBI110 in combination with a fixed dose of Sintilimab to determine the MTD. |
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| Phase Ib Expansion Stage:IBI110+ Sintilimab | Experimental | Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of IBI110 in combination with Sintilimab in different cancer types. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI110 | Drug | Several dose levels will be evaluated for IBI110 administered as a single agent and in combination with Sintilimab. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI110 may receive combination treatment with IBI110 plus Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with AEs and SAEs | To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab [Adverse events (AEs), Serious Adverse Events (SAEs) ] | up to 2 years after enrollment |
| Percentage of Participants with Dose-Limiting Toxicities (DLTs) | To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab. | From Baseline to the end of Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: AUC | The area under the curve (AUC) of serum concentration of the drug after the administration. | up to 2 years after enrollment |
| Pharmacokinetics: Cmax | Maximum concentration (Cmax) of the drug after administration |
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Inclusion Criteria:
Exclusion Criteria:
17.Hydrothorax, ascites, and pericardial effusion with clinical symptoms requiring drainage.
18.Known history of hypersensitivity to any components of the IBI110 or Sintilimab.
19.Uncontrolled complications of disease.
20.Other acute or chronic illness, mental illness, or abnormal laboratory test values that may increase the risk of study participation or administration of study drugs, or interfere with the interpretation of study results.
21.History of other primary malignancies. 22. Pregnant or nursing females.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Qu, Bachelor | Contact | 86-18501735865 | qian.wu@innoventbio.com | |
| Caicun Zhou, M.D | Contact | +86 21 65115006 | caicunzhoudr@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41591537 | Derived | Wang Q, Xiong A, Mao C, Wang W, Cui J, Fang J, Zhuang W, Yang K, Zuo W, Yang J, Ye L, Zhang Z, Sheng Z, Liu Z, Wang D, Du X, Yi T, Long S, Xu N, Zhou C. Efficacy and safety of anti-LAG-3 IBI110 in combination with sintilimab and chemotherapy for advanced squamous non-small cell lung cancer: a randomized phase II study. Cancer Immunol Immunother. 2026 Jan 27;75(2):56. doi: 10.1007/s00262-026-04299-x. | |
| 39736787 |
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| IBI110 | Drug | IBI110 will be given with RP2D. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. |
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| IBI110+ Sintilimab | Drug | IBI110: Several dose levels will be evaluated for IBI110 in combination with Sintilimab. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI110. Combination treatment may continue until disease progression or loss of clinical benefit. |
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| IBI110+ Sintilimab | Drug | IBI110: IBI110 in combination with Sintilimab will be given with RP2D. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI110. Combination treatment may continue until disease progression or loss of clinical benefit. |
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| up to 2 years after enrollment |
| Immunogenicity: Percentage of ADA positive subjects | Immunogenicity: Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI110. | up to 2 years after enrollment |
| Preliminary anti-tumor activity of IBI110 (Objective Response Rate) | Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma. | up to 2 years after enrollment |
| Derived |
| Mao C, Xiong A, Qian J, Wang W, Liu Y, Zhang T, Wu Z, Ni H, Lu J, Long S, Zhao L, Chen Y, Zhou C, Xu N. Dual inhibition of LAG-3 and PD-1 with IBI110 and sintilimab in advanced solid tumors: the first-in-human phase Ia/Ib study. J Hematol Oncol. 2024 Dec 31;17(1):132. doi: 10.1186/s13045-024-01651-5. |