Payload Information
General Information of This Payload
| Payload ID | PAY0TVOPO |
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| Name | Mtoxin |
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| Target | DNA topoisomerase 1 (TOP1) | |||||
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
9MW2921 [Phase 1/2 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Key inclusion criteria: Age 18-75; ECOG 0-1; histologically confirmed advanced/metastatic malignancies refractory to standard therapy; ≥1 measurable lesion; adequate organ function; provision of tumor samples (≥5 slides); negative pregnancy test; commitment to contraception (6 months post-treatment); protocol compliance capability. Survival expectancy ≥3 months.
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| Administration Dosage |
All subjects will receive 9MW2921 by intravenous (IV) every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT05990452 | Phase Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase I/II First-in-human Study of 9MW2921 to Evaluate the Safety, Tolerability and Preliminary Efficacy of 9MW2921 in Patients With Advanced Solid Tumors
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| Primary Endpoint |
Primary endpoints include DLT assessment (21 days post-first dose), AE/SAE incidence (up to 2 years), and ORR (CR+PR rate per RECIST 1.1, monitored for 2 years or until treatment discontinuation).
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| Other Endpoint |
Secondary endpoints comprise PK parameters (Cmax/AUC/t½ over 1 year), ADA development (2 years), and efficacy measures (PFS/DoR/DCR per RECIST 1.1, tracked for 2 years or until progression/death).
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