Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0YRJDY)
| ADC Name |
ALT-P7
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| Synonyms |
ALT-P7
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| Organization |
Alteogen (Originator);3SBio
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
2
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| Antibody Name |
Trastuzumab variant
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Val-Cit dipeptide linker
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Linker Info | ||||
| Conjugate Type |
Reactive Cysteines
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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] | ||||
| Efficacy Data | Progression Free Survival |
6.2 months
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| Patients Enrolled |
Eligible patients must be ≥19 years old with ECOG 0-1, adequate organ function (hematologic/renal/hepatic), and negative pregnancy status. Key exclusions include trastuzumab intolerance, active CNS metastases, unresolved Grade ≥2 toxicities, recent anticancer therapies (<3 weeks), significant cardiopulmonary dysfunction (LVEF<50%, NYHA II-IV), active infections (HIV/HBV/HCV), or other malignancies within 5 years (except specified cured cancers).
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| Administration Dosage |
8 groups: 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.2 mg/kg, 4.5 mg/kg, 4.8 mg/kg, Administration: Day 1 of each 3-week cycle
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| Related Clinical Trial | |||||
| NCT Number | NCT03281824 | Clinical Status | PHASE1 | ||
| Clinical Description | Open-Label, Dose Increase and Phase I Study of ALT-P7 to Determine Safety, Tolerability, Pharmacokinetics for HER2 Positive Metastatic Breast Cancer Patients Who Have Progressed on Previous Trastuzumab-Based Therapy | ||||
| Primary Endpoint |
The study evaluates safety endpoints including dose-limiting toxicities (DLTs) during the 21-day assessment period to determine maximum tolerated dose (MTD) or recommended phase II dose (RP2D), along with treatment-emergent adverse events (TEAEs) graded by CTCAE v4.03 with special focus on immune-related adverse events (irAEs) monitored for up to 4 weeks post-treatment.
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| Other Endpoint |
Pharmacokinetic analysis assesses ALT-P7 metabolism across dose groups (1.2-5.4 mg/kg) from administration to elimination, while immunogenicity testing evaluates anti-drug antibody responses. Efficacy outcomes are analyzed descriptively after Cycle 2 (42 days), including subject counts, means, standard deviations, and ranges for each dose cohort.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
77.30%
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| Patients Enrolled |
Eligible patients must be ≥19 years old with ECOG 0-1, adequate organ function (hematologic/renal/hepatic), and negative pregnancy status. Key exclusions include trastuzumab intolerance, active CNS metastases, unresolved Grade ≥2 toxicities, recent anticancer therapies (<3 weeks), significant cardiopulmonary dysfunction (LVEF<50%, NYHA II-IV), active infections (HIV/HBV/HCV), or other malignancies within 5 years (except specified cured cancers).
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| Administration Dosage |
8 groups: 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.2 mg/kg, 4.5 mg/kg, 4.8 mg/kg, Administration: Day 1 of each 3-week cycle
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| Related Clinical Trial | |||||
| NCT Number | NCT03281824 | Clinical Status | PHASE1 | ||
| Clinical Description | Open-Label, Dose Increase and Phase I Study of ALT-P7 to Determine Safety, Tolerability, Pharmacokinetics for HER2 Positive Metastatic Breast Cancer Patients Who Have Progressed on Previous Trastuzumab-Based Therapy | ||||
| Primary Endpoint |
The study evaluates safety endpoints including dose-limiting toxicities (DLTs) during the 21-day assessment period to determine maximum tolerated dose (MTD) or recommended phase II dose (RP2D), along with treatment-emergent adverse events (TEAEs) graded by CTCAE v4.03 with special focus on immune-related adverse events (irAEs) monitored for up to 4 weeks post-treatment.
Click to Show/Hide
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| Other Endpoint |
Pharmacokinetic analysis assesses ALT-P7 metabolism across dose groups (1.2-5.4 mg/kg) from administration to elimination, while immunogenicity testing evaluates anti-drug antibody responses. Efficacy outcomes are analyzed descriptively after Cycle 2 (42 days), including subject counts, means, standard deviations, and ranges for each dose cohort.
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| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
13.30%
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| Patients Enrolled |
Patients with HER2-positive advanced breast cancer progressive to at least two kinds of prior anti-HER2 treatment.
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| Administration Dosage |
0.30-4.80 mg/kg iv administered once every 3 weeks.
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| Related Clinical Trial | |||||
| NCT Number | NCT03281824 | Clinical Status | Phase 1 | ||
| Clinical Description | Open-label, dose increase and phase 1 study of ALT-P7 to determine safety, tolerability, pharmacokinetics for HER2 positive metastatic breast cancer patients who have progressed on previous trastuzumab-based therapy. | ||||
References