General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0WOBTH
ADC Name
DS-3939
Synonyms
DS-3939; GT-00A ADC; DS-3939a
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Organization
Daiichi Sankyo (Originator)
Drug Status
Phase 1/2
Drug-to-Antibody Ratio
7.9
Structure
Antibody Name
Gatipotuzumab
 Antibody Info 
Antigen Name
Mucin-1 (MUC1)
 Antigen Info 
Payload Name
DXd
 Payload Info 
Therapeutic Target
DNA topoisomerase 1 (TOP1)
 Target Info 
Linker Name
Mc-Gly-Gly-Phe-Gly
 Linker Info 
Conjugate Type
Random Cysteines
Combination Type
deruxtecan
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
Unspecific solid tumor
1 Trials
Trial ID
NCT05875168; jRCT2031230233; EUCT2023-507937-14-00; CTR20252034
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  NCT05875168
PHASE1|||PHASE2
Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects 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
Eligible patients (ECOG 0-1, LVEF ≥50%, measurable disease) must provide tumor samples for MUC1 analysis; exclusions include prior MUC1 therapy, active CNS metastases, uncontrolled infections (HIV/HBV/HCV), interstitial lung disease, or thromboembolic/autoimmune disorders within 6 months.
Administration Dosage
One IV infusion Q3W on Day 1 of each 21-day cycle.
Related Clinical Trial
NCT Number NCT05875168  Clinical Status PHASE1|||PHASE2
Clinical Description Phase 1/2, Open-label, Multicenter, First-in-Human Study of DS-3939a in Subjects With Advanced Solid Tumors
Primary Endpoint
The study assesses dose-limiting toxicities (DLTs) within 3 months and tracks treatment-emergent adverse events (AEs) with objective response rates over ~31 months.
Other Endpoint
Efficacy is evaluated via objective response rate, disease control rate, duration of response, and survival outcomes (PFS, OS) over ~31 months, alongside pharmacokinetic (AUC, Cmax, Tmax, T1/2) and immunogenicity (anti-drug antibodies) profiling extending up to 47 months, with TA-MUC1 expression analyzed at baseline.
References
Ref 1 First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors