Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0HTJXN
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| ADC Name |
TQB2103
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| Synonyms |
TQB2103
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| Organization |
Chia Tai Tianqing Pharmaceutical (CTTQ) (Originator)
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
8
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| Antibody Name |
Anti-CLDN18.2 IgG1 mAb
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Antibody Info | ||||
| Antigen Name |
Claudin-18.2 (CLDN18.2)
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Antigen Info | ||||
| Payload Name |
2-DDDX-d
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
A cleavable linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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2027 Update
The indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||
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| Unspecific solid tumor |
1 Trials
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General Information of The Activity Data Related to This ADC
Full List of Activity Data of This Antibody-drug Conjugate
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. | ||||
| 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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