Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0THGAW
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| ADC Name |
Trastuzumab duocarmazine
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| Synonyms |
SYD 985; SYD-985; SYD985; (vic-)trastuzumab-duocarmazine; Anti-HER2 ADC (Byondis); humanized monoclonal antibody conjugated to the pro-drug seco-duocarmycinhydroxyb; Trastuzumab vc-seco-DUBA; Trastuzumab-SYD980
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| Organization |
Synthon BV; Byondis BV
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| Drug Status |
NDA
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| Indication |
In total 5 Indication(s)
HER2(+) breast cancer [ICD11:2C60-2C65]
NDA
Breast cancer [ICD11:2C60-2C65]
Phase 3
Endometrial cancer [ICD11:2C76]
Phase 2
Gastric cancer [ICD11:2B72]
Phase 1
Non-small cell lung cancer [ICD11:2C25]
Terminated
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| Drug-to-Antibody Ratio |
2.8
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| Structure |
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| Antibody Name |
Trastuzumab
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (ERBB2)
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Antigen Info | ||||
| Payload Name |
seco-DUBA
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Payload Info | ||||
| Therapeutic Target |
Human Deoxyribonucleic acid (hDNA)
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Target Info | ||||
| Linker Name |
Mal-PEG2-Val-Cit-PABA-Cyclization Spacer
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Linker Info | ||||
| Conjugate Type |
Random conjugation through reduced inter-chain cysteines.
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| Combination Type |
Duocarmazine
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| Special Approval(s) |
Fast track(FDA)
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| Puchem SID | ||||||
| Drugbank ID | ||||||
| TTD ID | ||||||
| ChEBI ID | ||||||
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Discovered Using Patient-derived Xenograft Model
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] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT03262935 | Clinical Status | Phase 3 | ||
| Clinical Description | A multi-centre, open-label, randomized clinical trial comparing the efficacy and safety of the antibody-drug conjugate SYD985 to physician's choice in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04205630 | Clinical Status | Phase 2 | ||
| Clinical Description | A single-arm phase 2 trial to evaluate the safety and efficacy of the antibody-drug conjugate (ADC) SYD985 in patients with human epidermal growth factor receptor 2 (HER2)-expressing endometrial carcinoma who previously progressed on or after first line platinum-based chemotherapy. | ||||
| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT01042379 | Clinical Status | Phase 2 | ||
| Clinical Description | I-SPY trial (investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2). | ||||
| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04983238 | Clinical Status | Phase 1 | ||
| Clinical Description | A multicenter, randomized, double-blind, placebo-controlled trial with a single arm run-in period to evaluate the safety and efficacy of sodium thiosulfate (BYON5667) Eye drops to reduce ocular toxicity in cancer patients treated with SYD985. | ||||
| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04602117 | Clinical Status | Phase 1 | ||
| Clinical Description | ISPY-P1.01: evaluating the safety of weekly paclitaxel with trastuzumab duocarmazine (SYD985) in patients with metastatic cancer: a phase 1/Ib trial. | ||||
| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT04235101 | Clinical Status | Phase 1 | ||
| Clinical Description | A two-part phase 1 study with the antibody-drug conjugate SYD985 in combination with niraparib to evaluate safety, pharmacokinetics and efficacy in patients with HER2-expressing locally advanced or metastatic solid tumors. | ||||
| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT02277717 | Clinical Status | Phase 1 | ||
| Clinical Description | A two part first-in-human phase 1 study (with expanded cohorts) with the antibody-drug conjugate SYD985 to evaluate the safety, pharmacokinetics and efficacy in patients with locally advanced or metastatic solid tumors. | ||||
Discovered Using Patient-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 33.30% (Day 76) | High HER2 expression (HER2+++; IHC 3+; FISH+) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 3 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Breast cancer PDX model (PDX: MAXF-1162) | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 42.90% (Day 80) | Low HER2 expression (HER2+; IHC +; FISH-) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 3 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Breast cancer PDX model (PDX: MAXF 449) | ||||
| Experiment 3 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 65.00% (Day 80) | Moderate HER2 expression (HER2++; IHC 2+; FISH-) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 3 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Breast cancer PDX model (PDX: HBCx-34) | ||||
| Experiment 4 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 66.70% (Day 31) | Moderate HER2 expression (HER2++; IHC 2+; FISH-) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 3 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Breast cancer PDX model (PDX: ST313) | ||||
| Experiment 5 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 75.00% (Day 28) | Low HER2 expression (HER2+; IHC +; FISH-) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 10 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Gastric cancer PDX model (PDX: GXA3057) | ||||
| Experiment 6 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 90.00% (Day 46) | Moderate HER2 expression (HER2++; IHC 2+; FISH-) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 10 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Gastric cancer PDX model (PDX: GXA3038) | ||||
| Experiment 7 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100.00% (Day 20) | High HER2 expression (HER2+++; IHC 3+; FISH+) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 10 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Gastric cancer PDX model (PDX: GXA3054) | ||||
| Experiment 8 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100.00% (Day 21) | Moderate HER2 expression (HER2++; IHC 2+; FISH+) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 10 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Gastric cancer PDX model (PDX: GXA3067) | ||||
| Experiment 9 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100.00% (Day 41) | High HER2 expression (HER2+++; IHC 3+; FISH+) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 10 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Bladder cancer PDX model (PDX: BXF439) | ||||
| Experiment 10 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100.00% (Day 32) | Low HER2 expression (HER2+; IHC +; FISH-) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 3 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Breast cancer PDX model (PDX: MAXF-MX1) | ||||
| Experiment 11 Reporting the Activity Date of This ADC | [8] | ||||
| Efficacy Data | Tumor Growth Inhibition value (TGI) | ≈ 100.00% (Day 40) | Low HER2 expression (HER2+; IHC +; FISH-) | ||
| Method Description |
All treatments were conducted at day 0 by a single dose, i.v, 3 mg/kg x1 injection into the tail vein, Data, depicted as mean tumour volume, consists of 6-8 animals per experimental group.
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| In Vivo Model | Breast cancer PDX model (PDX: HBCx-10) | ||||
References
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