Payload Information
General Information of This Payload
| Payload ID | PAY0EGSDQ |
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| Name | Tubulysin 196 |
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| Synonyms |
Tubulysin 196
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| Target | Microtubule (MT) | |||||
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
DAC-002 [Phase 1 (discontinued)]
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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| Related Clinical Trial | |||||
| NCT Number | NCT04601285 | Phase 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.
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| 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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