General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0LLSDP
ADC Name
9MW2921
Synonyms
9MW2921
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Organization
Mabwell Bioscience (Originator)
Drug Status
Phase 1/2 (discontinued)
Drug-to-Antibody Ratio
4
Antibody Name
Anti-TROP2 antibody
 Antibody Info 
Antigen Name
Tumor-associated calcium signal transducer 2 (TACSTD2)
 Antigen Info 
Payload Name
Mtoxin
 Payload Info 
Payload Target
DNA topoisomerase 1 (TOP1)
 Target Info 
Linker Name
A cleavable linker
 Linker Info 
Conjugate Type
Reactive Cysteines
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
Unspecific solid tumor
1 Trials
Trial ID
NCT05990452; CTR20232341
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT05990452
PHASE1|||PHASE2
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
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
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.
Related Clinical Trial
NCT Number NCT05990452  Clinical 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
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).
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).
References
Ref 1 Phase I/II FIH Study of 9MW2921 in Patients With Advanced Solid Tumors