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YL202

Phase 1

Non Small Cell Lung Cancer | Small molecule | Oncology |BioNTech SE|Last Updated: May 15, 2026

Target and mechanism

Molecular targetHER3
Target classAdc
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

YL202 · 1 trial · 2 indications

Phase 1 1
NCT05653752A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast CancerNon Small Cell Lung Cancer
ACTIVE NOT_RECRUITING80 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer
Non Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the occurrence of DLTs during the first cycle
At the end of Cycle 1 (each cycle is 21 days)
Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
By the global end of trial date, approximately within 36 months

Secondary Endpoints

Characterize the PK parameter AUC
Approximately within 36 months
Characterize the PK parameter Cmax
Approximately within 36 months
Characterize the PK parameter Ctrough
Approximately within 36 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
YL202 Dose escalationEXPERIMENTALYL202 will be administrated intravenously (IV) per dose level in which the patients are assigned.

Interventions

NameTypeDescription
YL202DRUGYL202 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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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria Patients must satisfy all of the following criteria to be included in the study: 1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the informed consent form 2. Aged ≥18 years 3. Eastern Cooperative Oncology Group performance statu...

Countries:United StatesChina
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials (matched to "Non Small Cell Lung Cancer")

Frequently asked questions about YL202

What is YL202 used for?

YL202 is an investigational drug being studied for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) and breast cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does YL202 target?

YL202 targets HER3, a member of the human epidermal growth factor receptor family. It is an antibody-drug conjugate (ADC) designed to deliver a cytotoxic payload to cancer cells expressing HER3, which is implicated in tumor growth and survival.

Who is developing YL202?

YL202 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and efficacy of YL202 in patients with certain types of cancer.

What phase is YL202 in?

YL202 is in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and preliminary efficacy of the drug in patients with locally advanced or metastatic non-small cell lung cancer and breast cancer. It is not yet approved for commercial use.

What clinical trials is YL202 in?

YL202 is being evaluated in a Phase 1 clinical trial with the identifier NCT05653752. This study is enrolling approximately 80 patients with locally advanced or metastatic non-small cell lung cancer and breast cancer at sites in the United States and China. The trial is currently active but not recruiting new participants.