Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YRJDY
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| 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 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
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Antigen Info | ||||
| Payload Name |
MMAE
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Payload Info | ||||
| Therapeutic 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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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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| Breast cancer |
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] | ||||
| 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