DB-1303/BNT323

DRUG3 trials

Sponsors

DualityBio Inc.

Conditions

HER2-positive Advanced Solid TumorHER2-positive Breast CancerMetastatic Breast Cancer

Phase 1

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

RecruitingNCT05150691

DualityBio Inc.HER2-positive Advanced Solid Tumor

Start: 2022-01-31End: 2027-10-01Target: 796Updated: 2026-01-28

Phase 3

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

Active, not recruitingNCT06018337

DualityBio Inc.Metastatic Breast Cancer

Start: 2024-01-18End: 2028-07-01Updated: 2026-03-05

A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer

Active, not recruitingNCT06265428

DualityBio Inc.HER2-positive Breast Cancer

Start: 2024-01-29End: 2026-02-28Updated: 2025-10-17

Related Papers

Safety and efficacy of DB-1303 in patients with advanced/metastatic solid tumors: A multicenter, open-label, first-in-human, phase 1/2a study.

Journal of Clinical Oncology2023-06-0113 citations

Abstract CT247: A Phase 1/2a, multicenter, open-label, non-randomized first-in-human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1303 in patients with advanced/metastatic solid tumors

Cancer Research2023-04-14

Abstract 2793: Preclinical pharmacokinetics in cynomolgus monkeys and first in human dose prediction of DB-1303, a HER2-targeting antibody-drug conjugate

Cancer Research2023-04-04