Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0FWMPN
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| ADC Name |
YL202
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| Synonyms |
YL202; BNT326
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| Organization |
MediLink Therapeutics (Originator);BioNTech
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
Anti-HER3 IgG1 mAb
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-3 (ERBB3); Tumor-associated calcium signal transducer 2 (TACSTD2)
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Antigen Info | ||||
| Payload Name |
YL0010014
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
VK*G-NHCH2-O linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
pelitecan
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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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4 Trials
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1 Trials
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| Cervical cancer |
1 Trials
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3 Trials
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| Colorectal cancer |
3 Trials
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| Gastric cancer |
2 Trials
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| Gastroesophageal junction adenocarcinoma |
2 Trials
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| Head and neck cancer |
2 Trials
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| Lung cancer |
1 Trials
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1 Trials
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1 Trials
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1 Trials
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| Melanoma |
1 Trials
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| Ovarian cancer |
2 Trials
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| Pancreatic cancer |
2 Trials
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| Prostate cancer |
2 Trials
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| Unspecific solid tumor |
1 Trials
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3 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 | Objective Response Rate (ORR) |
37%
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| Patients Enrolled |
Eligible patients must be ≥18 years old, have adequate organ function, and meet disease-specific criteria (NSCLC: EGFR-mutant, prior 3rd-gen TKI; BC: HR+/HER2-, prior CDK4/6i + endocrine therapy). Key exclusions include prior HER3-targeted therapy, uncontrolled cardiovascular/ocular disease, active infections, severe toxicities, or unresolved organ dysfunction. Pregnancy, breastfeeding, or immunosuppressive conditions are also disqualifying.
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| Administration Dosage |
YL202 is provided as the lyophilized powder, 200 mg/vial. YL202 will be given intravenously once every 3 weeks (Q3W) as a cycle. The initial dose of YL202 will be infused IV into each patient for 90 ±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL202 will be infused IV into each patient for 60 ±10 minutes.
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| Related Clinical Trial | |||||
| NCT Number | NCT05653752 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, Multicenter, Open-label, First-in-human Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer | ||||
| Primary Endpoint |
This study evaluates dose-limiting toxicities (DLTs) during the first 21-day cycle and assesses adverse events (AEs) by type, frequency, severity, timing, seriousness, and relation to treatment over approximately 36 months.
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| Other Endpoint |
Pharmacokinetic (PK) parameters including AUC, Cmax, Ctrough, CL, Vd, and t1/2 will be characterized. Immunogenicity (anti-YL202 antibodies) and efficacy outcomes such as objective response rate (ORR), disease control rate (DCR), and best tumor response per RECIST v1.1 will also be analyzed over a 36-month period.
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| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
93.50%
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| Patients Enrolled |
Eligible patients must be ≥18 years old, have adequate organ function, and meet disease-specific criteria (NSCLC: EGFR-mutant, prior 3rd-gen TKI; BC: HR+/HER2-, prior CDK4/6i + endocrine therapy). Key exclusions include prior HER3-targeted therapy, uncontrolled cardiovascular/ocular disease, active infections, severe toxicities, or unresolved organ dysfunction. Pregnancy, breastfeeding, or immunosuppressive conditions are also disqualifying.
Click to Show/Hide
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| Administration Dosage |
YL202 is provided as the lyophilized powder, 200 mg/vial. YL202 will be given intravenously once every 3 weeks (Q3W) as a cycle. The initial dose of YL202 will be infused IV into each patient for 90 ±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL202 will be infused IV into each patient for 60 ±10 minutes.
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| Related Clinical Trial | |||||
| NCT Number | NCT05653752 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, Multicenter, Open-label, First-in-human Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer | ||||
| Primary Endpoint |
This study evaluates dose-limiting toxicities (DLTs) during the first 21-day cycle and assesses adverse events (AEs) by type, frequency, severity, timing, seriousness, and relation to treatment over approximately 36 months.
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| Other Endpoint |
Pharmacokinetic (PK) parameters including AUC, Cmax, Ctrough, CL, Vd, and t1/2 will be characterized. Immunogenicity (anti-YL202 antibodies) and efficacy outcomes such as objective response rate (ORR), disease control rate (DCR), and best tumor response per RECIST v1.1 will also be analyzed over a 36-month period.
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| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients had advanced/metastatic HR-/HER2- or HR+/HER2-low breast cancer post-ADC failures, measurable lesions, adequate organ function, and life expectancy ≥3 months. Key exclusions included prior HER3 therapy, topoisomerase I inhibitor intolerance, active infections, uncontrolled comorbidities, recent major surgery/vaccines, CNS metastases, or other malignancies within 5 years.
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| Administration Dosage |
YL202 is provided as the lyophilized powder, 200 mg/vial. Patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT06439771 | Clinical Status | PHASE2 | ||
| Clinical Description | A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With Locally Advanced or Metastatic Breast Cancer With TNBC, HR-Positive, HER2-Zero-expression or HER2-Low-expression | ||||
| Primary Endpoint |
The primary endpoint was ORR (CR+PR) per RECIST v1.1 over 36 months, along with determining YL202's recommended dose for pivotal studies.
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| Other Endpoint |
Key secondary endpoints included PFS, CBR, DpR, DCR, DOR, TTR, OS, AE profiling, PK parameters (AUC, Cmax, Ctrough, CL, Vd, t1/2), immunogenicity (anti-YL202 antibodies), and HER3 expression correlation with response rates, all assessed over ~36 months.
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| Experiment 4 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients (18-75 years) must have histologically confirmed advanced/metastatic solid tumors (e.g., NSCLC, BC, HNSCC), ≥1 measurable lesion, ECOG PS 0-1, adequate organ function, and contraception compliance. Exclusions involve prior HER3-targeted therapy, topoisomerase I inhibitor intolerance, recent major surgery/live vaccines, uncontrolled comorbidities (CNS metastases, cardiovascular/pulmonary/GI disorders, infections, HIV/HBV/HCV), other malignancies, or pregnancy/lactation.
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| Administration Dosage |
YL202 is provided as the lyophilized powder, 200 mg/vial. Patients will be given YL202 by intravenously once every 3 weeks (Q3W) as a cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT06107686 | Clinical Status | PHASE2 | ||
| Clinical Description | A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients with Advanced Solid Tumors | ||||
| Primary Endpoint |
The primary endpoints include ORR (complete or partial response rate per RECIST v1.1) and determination of YL202's recommended dose, assessed within 36 months.
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| Other Endpoint |
Secondary endpoints evaluated within 36 months encompass efficacy measures (PFS, CBR, DpR, DCR, DOR, TTR, OS), safety (AE profile), PK parameters (AUC, Cmax, Ctrough, CL, Vd, t1/2), immunogenicity (anti-YL202 antibody), exposure-response modeling, and HER3 expression correlation with clinical response rates.
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References
