Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0RLBGI
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| ADC Name |
DXC006
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| Synonyms |
DXC006; DXC-006
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| Organization |
Hangzhou DAC Biotechnology (DAC Biotech) (Originator)
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
2
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| Antibody Name |
DXA006
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Antibody Info | ||||
| Antigen Name |
Neural cell adhesion molecule 1 (NCAM1)
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Antigen Info | ||||
| Payload Name |
CPT113
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
A cleavable peptide linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Lung cancer |
1 Trials
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| Multiple myeloma |
1 Trials
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| Unspecific non-hodgkin lymphoma |
1 Trials
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| Unspecific solid tumor |
1 Trials
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General Information of The Activity Data Related to This ADC
Revealed Based on the Cell Line Data
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Revealed Based on the Cell Line Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Half Maximal inhibitory Concentration (lC50) | 0.0046-0.061 nM | Positive CD56 expression (CD56+++/++) | ||
| Method Description |
Cytotoxicity of ADC to CD56 positive IMR-32 cells
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| In Vitro Model | Lung small cell carcinoma | NCI-H526 cells | CVCL_1569 | ||
| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Half Maximal inhibitory Concentration (lC50) | 0.0046-0.061 nM | Positive CD56 expression (CD56+++/++) | ||
| Method Description |
Cytotoxicity of ADC to CD56 NCI-H526 positive cells
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| In Vitro Model | Lung small cell carcinoma | NCI-H526 cells | CVCL_1569 | ||
| Experiment 3 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Half Maximal inhibitory Concentration (lC50) | 0.0046-0.061 nM | Positive CD56 expression (CD56+++/++) | ||
| Method Description |
Cytotoxicity of ADC to CD56 positive NCI-H929 cells
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| In Vitro Model | Lung small cell carcinoma | NCI-H526 cells | CVCL_1569 | ||
| Experiment 4 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Half Maximal inhibitory Concentration (lC50) | > 675 nM | |||
| Method Description |
Cytotoxicity of ADC to human NK cells
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| In Vitro Model | Lung small cell carcinoma | NCI-H526 cells | CVCL_1569 | ||
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients (≥18 years, ECOG 0-2) must consent, have ≥3-month life expectancy, and show target protein expression. Exclusions encompass recent transplants, uncontrolled CVD (QTcF≥470ms, NYHA III-IV), active HBV/HCV/HIV/syphilis, pregnancy, major surgery within 28 days, bleeding disorders, or live vaccinations within 28 days. Organ function thresholds vary by disease status.
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| Administration Dosage |
Dose escalation period: DXC006 is administered intravenously every two weeks (Q2W) at the dose corresponding to the enrolled dose cohort.Dose expansion period: DXC006 is administered intravenously Q2W at the corresponding dose.
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| Related Clinical Trial | |||||
| NCT Number | NCT06224855 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open-label Dose Escalation and Cohort Expansion Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and and Efficacy of DXC006 in Patients With Advanced Solid Tumors and Hematologic Malignancies | ||||
| Primary Endpoint |
The study will quantify dose-limiting toxicities (DLTs) within 28 days to establish maximum tolerated dose, while monitoring adverse events (CTCAE v5.0) for approximately 1 year post-treatment.
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| Other Endpoint |
Pharmacokinetic analysis includes Cmax, Tmax, Vd, Vss, t½, AUC0-t/0-inf, and CL measurements over 1 year. Immunogenicity (ADA titers), ORR (RECIST 1.1), DOR, PFS, and OS will be evaluated for 1 year post-enrollment.
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References