Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0YZEVV)
| ADC Name |
MT-5111
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| Synonyms |
MT 5111; MT-5111; MT5111
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| Organization |
Molecular Templates, Inc.
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| Drug Status |
Phase 1 (discontinued)
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| Antibody Name |
Undisclosed
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| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2)
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Antigen Info | ||||
| Payload Name |
Shiga toxin B subunit (StxB)
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Payload Info | ||||
| Payload Target |
Ribosome (RB)
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Target Info | ||||
| Linker Name |
Undisclosed
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
2027 Update
General Information of The ADMET Data Related to This ADC
Absorption
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) | 33 | ng/mL |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 6.75 ug/kg, N=5
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[2] |
| Maximum Observed Concentration (Cmax) | 0.6 | nM |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 6.75 ug/kg, N=5
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[2] |
| Maximum Observed Concentration (Cmax) | 54 | ng/mL |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 10 ug/kg, N=11
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[2] |
| Maximum Observed Concentration (Cmax) | 0.98 | nM |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 10 ug/kg, N=11
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[2] |
| Maximum Observed Concentration (Cmax) | 81 | ng/mL |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 13 ug/kg, N=3
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[2] |
| Maximum Observed Concentration (Cmax) | 1.47 | nM |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 13 ug/kg, N=3
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[2] |
| Maximum Observed Concentration (Cmax) | 93 | ng/mL |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 17 ug/kg, N=4
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[2] |
| Maximum Observed Concentration (Cmax) | 1.69 | nM |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 17 ug/kg, N=4
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[2] |
Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Elimination Half-Life (t1/2) | 2-5 | h |
MT-5111 was designed to achieve a short half-life to allow for efficient tumor cell targeting but minimal serum exposure time to avoid systemic effects over time. This short half-life was confirmed in primates
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[1] |
| Elimination Half-Life (t1/2) | 3.9 | h |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 6.75 ug/kg, N=5
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[2] |
| Elimination Half-Life (t1/2) | 6.9 | h |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 10 ug/kg, N=11
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[2] |
| Elimination Half-Life (t1/2) | 5.3 | h |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 13 ug/kg, N=3
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[2] |
| Elimination Half-Life (t1/2) | 6.6 | h |
A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, 17 ug/kg, N=4
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[2] |
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 | [3] | ||||
| 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 | Clinical 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 | ||||
| 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 | [4] | ||||
| 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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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT04757090 | Clinical 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 | ||||
| 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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References