Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0SSFSR
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| ADC Name |
DM001
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| Synonyms |
DM001; DM001 (Doma); BCG011
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| Organization |
Biocytogen (Originator);Sidao Medicine
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
Anti-EGFR/TROP2 bsAb
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Antibody Info | ||||
| Antigen Name |
Epidermal growth factor receptor (EGFR); Tumor-associated calcium signal transducer 2 (TACSTD2)
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Antigen Info | ||||
| Payload Name |
BCPT02
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Hydrophilic, protease-cleavable linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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| Combination Type |
BLD1102
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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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| Breast cancer |
1 Trials
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| Colorectal cancer |
1 Trials
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| Gastric cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Lung cancer |
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 |
Key inclusion criteria: signed consent; age ≥18; ECOG 0-1; metastatic breast cancer/EGFRmut or EGFRwt NSCLC/gastric/CRC refractory to standard therapy; measurable disease (RECIST 1.1); life expectancy ≥3 months.
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| Administration Dosage |
Subjects may continue to receive DM001 (with an increased dose that has been assessed as safe in the dose-escalation period) once every 3 weeks (Q3W) for a total of 6 cycles at the discretion of the investigators, until unacceptable toxicity, progressive disease (PD), or withdrawal of consent.
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| Related Clinical Trial | |||||
| NCT Number | NCT06475937 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM001 in Patients with Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include DLT incidence (grade 3 neurological/grade 4 toxicities) and MTD determination (dose with ≤1/6 DLTs) for DM001 over 12 months.
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| Other Endpoint |
Secondary endpoints comprise PK parameters (AUC0-inf, Cmax, Tmax, Ctrough) and ORR (CR+PR per RECIST 1.1), all evaluated over 12 months.
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