Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0OLABW |
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| Antibody Name | Anti-CLDN18.2 IgG1 mAb |
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| Antigen Name | CLDN18.2 |
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
TQB2103 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients were aged 18-75 with advanced solid tumors, ECOG PS 0-1, and adequate organ function. Prior Claudin18.2-targeted therapy excluded, while Claudin18.2 testing was preferred. Exclusion criteria included major comorbidities, uncontrolled effusions, recent anticancer therapy, active CNS metastases, hypersensitivity to monoclonal antibodies, or conditions deemed unsafe by investigators.
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| Administration Dosage |
Dose escalation:intravenous infusion of TQB2103 for injection once every three weeks, 21 days as one treatment cycle. (0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 3.0 mg/kg, 4.0 mg/kg, 5.0mg/kg)Dose expansion:Chose one or two appropriate dose groups in the dose escalation experiment to expand.
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| Related Clinical Trial | |||||
| NCT Number | NCT05867563 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase I Clinical Trial Evaluating Tolerance, Safety, Pharmacokinetics, and Initial Effectiveness of TQB2103 for Injection in Patients With Advanced Cancers.
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| Primary Endpoint |
The study evaluated dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended Phase II dose (RP2D) during the first 21-day treatment cycle. DLT was defined as toxicities meeting NCI CTCAE v5.0 criteria, MTD as the highest dose with <33% DLT incidence, and RP2D was determined based on toxicity, pharmacokinetics, pharmacodynamics, and efficacy data.
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| Other Endpoint |
Key pharmacokinetic parameters included AUC, Cmax, T1/2, CL/F, and Vss/F, measured at specific timepoints over multiple 21-day cycles. Immunogenicity assessed anti-drug antibodies (ADA). Clinical outcomes included ORR, DCR, DOR, PFS, OS, and adverse event rates over up to 2 years, with response criteria per RECIST v1.1 and safety per CTCAE 5.0.
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