Payload Information
General Information of This Payload
| Payload ID | PAY0MXQKD |
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| Name | BCPT02 |
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| Synonyms |
BCPT02
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| Target | DNA topoisomerase 1 (TOP1) | |||||
| Structure |
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Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
DM002 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients (≥18 years, ECOG 0-2, life expectancy ≥3 months) must have measurable disease (RECIST 1.1), adequate organ function
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| Administration Dosage |
An IV infusion of DM002 will be administrated approximately 30-60 min on D1 once Q3W
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| Related Clinical Trial | |||||
| NCT Number | NCT06751329 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase I, Multicentre, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors
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| Primary Endpoint |
Safety assessment includes DLT evaluation (grade 3 neurological/grade 4 toxicities) and MTD determination (0/3 or 1/6 DLT rate) for DM002 over 12 months.
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| Other Endpoint |
PK parameters (AUC, Cmax, Tmax, Ctrough) and efficacy (ORR per RECIST 1.1) will be analyzed for 12 months.
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DM001 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [2] | ||||
| 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 | Phase 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
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| 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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DM005 [Phase 1]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent; age ≥18; advanced/metastatic solid tumors (NSCLC, gastroesophageal/colorectal/HCC/pancreatic/HNSCC) refractory to standard therapy; ECOG 0-2; life expectancy ≥3 months; measurable disease (RECIST 1.1).
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| Administration Dosage |
An IV infusion of DM005 will be administrated approximately 30-60 min on D1 once Q3W, 0.5, 1, 2, 4, 6, 8 mg/kg.
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| Related Clinical Trial | |||||
| NCT Number | NCT06515990 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors
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| Primary Endpoint |
Primary endpoints include DLT incidence (grade 3 neurological/grade 4 toxicities) and MTD determination (0/3 or 1/6 DLT rate) for DM005 over 12 months.
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| Other Endpoint |
Secondary endpoints comprise PK parameters (AUC, Cmax, Tmax, Ctrough) and ORR assessment (RECIST v1.1) within 12 months.
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References