Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0BZCIJ)
| ADC Name |
DAC-002
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| Synonyms |
DAC-002; JS108; DAC002
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| Organization |
Hangzhou DAC Biotechnology (DAC Biotech) (Originator);TopAlliance Biosciences (Junshi Biosciences)
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| Drug Status |
Phase 1 (discontinued)
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| Antibody Name |
Anti-TROP2 antibody
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Antibody Info | ||||
| Antigen Name |
Tumor-associated calcium signal transducer 2 (TACSTD2)
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Antigen Info | ||||
| Payload Name |
Tubulysin 196
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
2,3-disubstituted long side-chain hydrolysis-resistant linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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 |
Eligible patients (18-75 years with ECOG 0-1) must have progressing advanced solid tumors after standard therapy, measurable disease per RECIST 1.1, and adequate organ function. Required fresh/archived tumor tissue within 1 year and recovery of prior treatment toxicities to ≤Grade 1 (excluding alopecia). Women of childbearing potential need negative pregnancy test.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT04601285 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors. | ||||
| Primary Endpoint |
The MTD determination will be based on DLTs observed during the first 21 days post-infusion, with safety monitoring continuing throughout the 1-year study period using CTCAE v5.0 criteria. Investigators will assess AE causality relative to JS108 treatment.
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| Other Endpoint |
Pharmacokinetic analysis will assess JS108 parameters including Cmax, Tmax, AUC0-inf, Vss, t½ and CL over one year. Secondary endpoints include immunogenicity (ADA), efficacy measures (ORR per RECIST 1.1, DOR, PFS, OS), and exploratory Trop2 biomarker correlations with response and toxicity.
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