marked.bio

HER3 ADC · ADC

YL202

5 active trials across 4 of our biomarkers, targeting HER3. Not approved for any biomarker on marked.bio yet.

Also known as BNT326.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 4 4 Phase 3
ALK fusion 1 1 Phase 1/2
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 1 1 Phase 2
ROS1 fusion 1 1 Phase 1/2

Sponsors

Industry sponsors leading active biomarker-selected trials of YL202.

  1. MediLink Therapeutics 3
  2. BioNTech 2

Trials

5 of 5 trials shown

  1. Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer

    Recruiting Phase 3 MediLink Therapeutics Started 2026Primary completion 2028-08 NCT07416994

    YL202docetaxel

    …vanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  2. A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

    Recruiting Phase 1/2 BioNTech Started 2025Primary completion 2028-03 NCT07070232

    YL202pumitamigitraconazoleparoxetine

    …est results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).

    EGFR exon 19 deletion / L858RAdvanced Solid Tumor

  3. A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

    Recruiting Phase 1/2 BioNTech Started 2025Primary completion 2028-11 NCT07111520

    YL202pumitamig

    …est results for an EGFR-sensitizing mutation (EGFR-sensitizing mutation Exon 21-L858R and 19del).

    EGFR exon 19 deletion / L858RALK fusionROS1 fusionNon-small Cell Lung Cancer

  4. A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC

    Recruiting Phase 2 MediLink Therapeutics Started 2024Primary completion 2027-07 NCT06439771

    YL202

    Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Locally Advanced or Metastatic Breast Cancer

  5. A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer

    Active, not recruiting Phase 1 MediLink Therapeutics Started 2022Primary completion 2026-12 NCT05653752

    YL202

    Have a documentation of an EGFR-activating mutation (exon 19 deletion or L858R) detected from tumor tissue at diagnosis or thereafter.

    EGFR exon 19 deletion / L858RNon Small Cell Lung Cancer, Breast Cancer