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This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy in patients with advanced malignancies.
Phase Ia study is composed of two stages: Phase Ia Part A initial dose escalation and Phase Ia Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design. The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 2 dose cohorts (0.3 mg/kg QW and 1 mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.
Phase Ia Part B will have 4 dose cohorts(3mg/kg QW#10mg/kg QW#20mg/kg QW #30mg/kg QW and 45mg/kg Q3W). DLT observation period is 28 days. The subject number for each cohort in Phase Ia Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI188 | Experimental | Part A : Initial dose escalation, Part B : Maintenance dose escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI188 | Drug | Part A: 0.1 mg/kg IV QW, 0.3 mg/kg IV QW, 1 mg/kg IV QW. Part B: 1mg/kg IV D1+3, 10, 20, 30 mg/kg IV D8 QW or 45mg/kg D8 IV Q3W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), Serious Adverse Events (SAE)Number of patients with AEs and SAEs | Incidence, correlation with the study drug and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary anti-tumor activity of IBI188 (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. | 24 months |
| Pharmacokinetics: Cmax |
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Inclusion Criteria:
Advanced solid tumors and lymphomas defined by:
Subject has at least 1 measurable disease per RECIST v1.1. Lymphomas have at least one measurable lesion and 18FDG-avid lesion according to the Lugano 2014 criteria.
Male or female subject above 18 years
ECOG Performance Status 0 to 1
Must have adequate organ and bone marrow function, including the following:
Subjects with life expectancy of ≥ 12 weeks
Female subjects of child-bearing potential or male subjects with female partners of child-bearing potential must be willing to use viable contraception method that is deemed effective by the investigator throughout the treatment period and for at least 6 months following the last dose of study drug.
Be willing to sign the Informed Consent Form (ICF), and can follow the visit schedule and procedures defined in the protocol.
Exclusion Criteria:
18. Subjects with moderate bilateral pleural effusion, or massive pleural effusion on one side, or respiratory dysfunction requiring drainage.
19. Pregnant or nursing females.
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| Name | Affiliation | Role |
|---|---|---|
| Song Yuqin | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40318595 | Derived | Cai S, Wei X, Li Q, Jiang Z, Li L. Smart materials in pharmacological drug development: Neutrophils and its constituents for drug delivery and consequent antitumor effects. Mol Immunol. 2025 Jul;183:18-32. doi: 10.1016/j.molimm.2025.04.010. Epub 2025 May 2. |
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Maximum concentration(Cmax) of the drug after administration |
| 24 months |
| Pharmacokinetics: AUC | The area under the curve (AUC) of serum concentration of the drug after the administration. | 24 months |
| Immunogenicity | Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of IBI188. | 24 months |