Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0BZCIJ
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| 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); Programmed cell death 1 ligand 1 (PD-L1)
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Antigen Info | ||||
| Payload Name |
Tubulysin 196
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Payload Info | ||||
| Therapeutic 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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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 | ||
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| Advance solid tumor |
1 Trials
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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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