marked.bio

HER2 ADC · ADC

DB-1303

2 active trials, targeting HER2. Not approved for any biomarker on marked.bio yet.

Also known as BNT323.

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
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 2 2 Phase 3

Sponsors

Industry sponsors leading active biomarker-selected trials of DB-1303.

  1. DualityBio 1
  2. BioNTech 1

Trials

2 of 2 trials shown

  1. A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

    Active, not recruiting Phase 3 DualityBio Started 2024Primary completion 2026-08 NCT06018337

    DB-1303capecitabinepaclitaxelnab-paclitaxel

    Has HER2-low expression (IHC 1+ or IHC 2+/ISH-) as determined by the central laboratory result.

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

  2. A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

    Recruiting Phase 1/2 BioNTech Started 2025Primary completion 2029-08 NCT06827236

    DB-1303trastuzumabpumitamig

    …s a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Cli…

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