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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
268
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.
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.
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.
Shanghai Pulmonary Hospital
Shanghai, China
RECRUITINGNumber of subjects with AEs and SAEs
To evaluate the safety and tolerability of IBI110 alone or in combination with Sintilimab \[Adverse events (AEs), Serious Adverse Events (SAEs) \]
Time frame: 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.
Time frame: From Baseline to the end of Cycle 1
Pharmacokinetics: AUC
The area under the curve (AUC) of serum concentration of the drug after the administration.
Time frame: up to 2 years after enrollment
Pharmacokinetics: Cmax
Maximum concentration (Cmax) of the drug after administration
Time frame: 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.
Time frame: 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.
Time frame: up to 2 years after enrollment
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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.