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ALT02 (trastuzumab biosimilar)
i
Other names: ALT02, ALT-L2, ALT L2, QL-1701
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Company:
Alteogen, Cristalia, Qilu Pharma
Drug class:
HER2 inhibitor
Related drugs:
3ms
QL1701 (a proposed trastuzumab biosimilar) versus reference trastuzumab plus docetaxel as first-line therapy for HER2-positive metastatic breast cancer: a multicenter, randomized, double-blinded, parallel-controlled, phase III equivalence trial. (PubMed, ESMO Open)
QL1701 demonstrated equivalent efficacy and similar safety to the reference trastuzumab when combined with docetaxel in the first-line treatment of patients with HER2-positive metastatic breast cancer, with similar PK and immunogenicity profiles.
Clinical • P3 data • Journal • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • EGFR positive
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Herceptin (trastuzumab) • docetaxel • ALT02 (trastuzumab biosimilar)
8ms
A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov)
P3, N=474, Completed, Qilu Pharmaceutical Co., Ltd. | Active, not recruiting --> Completed
Trial completion • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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Herceptin (trastuzumab) • docetaxel • ALT02 (trastuzumab biosimilar)
almost2years
A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov)
P3, N=474, Active, not recruiting, Qilu Pharmaceutical Co., Ltd. | Trial completion date: Apr 2023 --> Oct 2023 | Trial primary completion date: Aug 2022 --> Dec 2022
Trial completion date • Trial primary completion date • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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Herceptin (trastuzumab) • docetaxel • ALT02 (trastuzumab biosimilar)
2years
A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast Cancer (clinicaltrials.gov)
P3, N=474, Active, not recruiting, Qilu Pharmaceutical Co., Ltd.
New P3 trial • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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Herceptin (trastuzumab) • docetaxel • ALT02 (trastuzumab biosimilar)
over4years
[VIRTUAL] First-in-human phase I study of ALT-P7, a HER2-targeting antibody-drug conjugate in patients with HER2-positive advanced breast cancer. (ASCO 2020)
Background: ALT-P7 is an antibody-drug conjugate, in which two molecules of monomethyl auristatin E (MMAE) are site-specifically conjugated to a cysteine-containing peptide motif of trastuzumab variant... ALT-P7 was well tolerated to a dose of 4.2mg/kg in heavily pretreated HER2-positive advanced breast cancer. DLTs were observed at 4.8mg/kg, and 4.5mg/kg is under evaluation. The observed clinical activity warrants further evaluation in a phase 2 trial.
Clinical • P1 data
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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Herceptin (trastuzumab) • ALT-P7 • ALT02 (trastuzumab biosimilar)
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