Payload Information
General Information of This Payload
| Payload ID | PAY0EJXWD |
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| Name | Shiga toxin B subunit (StxB) |
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| Synonyms |
Shiga toxin B subuni (StxB)
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| Target | Ribosome (RB) | |||||
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
MT-5111 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients have HER2-positive unresectable/metastatic solid tumors (Part A: all types; Part B: breast/GEA) refractory to prior therapies, measurable/evaluable lesions (RECIST 1.1), ECOG ≤1, and adequate organ function. Exclusions include active CNS metastases, uncontrolled comorbidities, significant cardiovascular disease, or concurrent infections (HBV/HCV/HIV).
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| Administration Dosage |
The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle).
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| Related Clinical Trial | |||||
| NCT Number | NCT04029922 | Phase Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors
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| Primary Endpoint |
The primary objectives are to assess the safety and tolerability of MT-5111 by monitoring adverse events (CTCAE v5.0) and dose-limiting toxicities (DLTs) to determine the MTD/RP2D over 21-day cycles.
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| Other Endpoint |
Secondary objectives include evaluating MT-5111 pharmacokinetics (Cmax, Tmax, AUC) on Days 1/8/15 per cycle, tumor response (ORR per RECIST 1.1), and immunogenicity (ADA/NAb titers) at baseline, treatment cycles, and follow-up.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants must be enrolled in MT-5111_001 with ≥1 measurable lesion (RECIST 1.1; osteosarcoma exceptions permitted), have recent/planned FDG-PET/CT, and be capable of PET/CT imaging. Exclusions include hepatic-only disease and pregnancy/breastfeeding status.
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| Related Clinical Trial | |||||
| NCT Number | NCT04757090 | Phase Status | PHASE2 | ||
| Clinical Description |
A Pilot Study of 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
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| Primary Endpoint |
The primary imaging endpoint is the average 89Zr-trastuzumab SUVmax (maximum standardized uptake value) in lesions identified on baseline FDG-PET/CT scans.
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| Other Endpoint |
Secondary imaging analyses include average 89Zr-trastuzumab tumor-to-normal tissue and tumor-to-blood uptake ratios, along with intra-patient heterogeneity assessment (fractions of scan-positive/negative lesions) in multi-lesion cases.
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1B-3R ADC [Investigative]
Discovered Using Cell Line-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 57.11% | |||
| Method Description |
The inhibitory activity of 1B-3R conjugate against cancer cell growth was evaluated in various human cancer cell lines in vivo.
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| In Vivo Model | Colorectal cancer CDX model | ||||
| In Vitro Model | Colorectal cancer | Colorectal cancer cells | Homo sapiens | ||
References