General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0FWMPN
ADC Name
YL202
Synonyms
YL202; BNT326
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Organization
MediLink Therapeutics (Originator);BioNTech
Drug Status
Phase 3
Drug-to-Antibody Ratio
8
Structure
Antibody Name
Anti-HER3 IgG1 mAb
 Antibody Info 
Antigen Name
Receptor tyrosine-protein kinase erbB-3 (ERBB3); Tumor-associated calcium signal transducer 2 (TACSTD2)
 Antigen Info 
Payload Name
YL0010014
 Payload Info 
Therapeutic Target
DNA topoisomerase 1 (TOP1)
 Target Info 
Linker Name
VK*G-NHCH2-O linker
 Linker Info 
Conjugate Type
Random Cysteines
Combination Type
pelitecan
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
Breast cancer
1 Trials
Trial ID
NCT05653752; CTR20223146
4 Trials
Trial ID
ChiCTR2500105373
NCT06107686; CTR20233371
NCT06439771; CTR20241091
ChiCTR2400089158
1 Trials
Trial ID
NCT07461454; CTR20260709
Cervical cancer
1 Trials
Trial ID
NCT07070232; EudraCT2024-517261-16; EUCT2024-517261-16-00
3 Trials
Trial ID
NCT07202364; CTR20253821
ChiCTR2500105373
NCT06107686; CTR20233371
Colorectal cancer
3 Trials
Trial ID
NCT07202364; CTR20253821
ChiCTR2500105373
NCT06107686; CTR20233371
Gastric cancer
2 Trials
Trial ID
ChiCTR2500105373
NCT06107686; CTR20233371
Gastroesophageal junction adenocarcinoma
2 Trials
Trial ID
ChiCTR2500105373
NCT06107686; CTR20233371
Head and neck cancer
2 Trials
Trial ID
ChiCTR2500105373
NCT06107686; CTR20233371
Lung cancer
1 Trials
Trial ID
NCT05653752; CTR20223146
1 Trials
Trial ID
NCT07070232; EudraCT2024-517261-16; EUCT2024-517261-16-00
1 Trials
Trial ID
NCT07202364; CTR20253821
1 Trials
Trial ID
NCT07416994; CTR20260699
Melanoma
1 Trials
Trial ID
NCT07070232; EudraCT2024-517261-16; EUCT2024-517261-16-00
Ovarian cancer
2 Trials
Trial ID
ChiCTR2500105373
NCT06107686; CTR20233371
Pancreatic cancer
2 Trials
Trial ID
ChiCTR2500105373
NCT06107686; CTR20233371
Prostate cancer
2 Trials
Trial ID
ChiCTR2500105373
NCT06107686; CTR20233371
Unspecific solid tumor
1 Trials
Trial ID
NCT07070232; EudraCT2024-517261-16; EUCT2024-517261-16-00
3 Trials
Trial ID
NCT07202364; CTR20253821
ChiCTR2500105373
NCT06107686; CTR20233371
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 4 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT05653752
PHASE1
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
Disease control rate (DCR)  NCT05653752
PHASE1
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
Undisclosed  NCT06439771
PHASE2
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

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Undisclosed  NCT06107686
PHASE2
A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients with Advanced Solid Tumors
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 4 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
37%
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.
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.
Experiment 2 Reporting the Activity Date of This ADC [1]
Efficacy Data Disease control rate (DCR)
93.50%
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
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.

   Click to Show/Hide
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.
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.
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.

   Click to Show/Hide
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.
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.
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.
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.
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.
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.
References
Ref 1 A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer
Ref 2 A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
Ref 3 A Study of YL202 in Selected Patients with Advanced Solid Tumors