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HB1801

DRUG9 trials

Sponsors

Fudan University, Shanghai JMT-Bio Inc., CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Shanghai Runshi Pharmaceutical Technology Co., Ltd

Conditions

Advanced Breast CancerBreast CancerBreast NeoplasmBreast TumorsEarly or Locally Advanced HER2-positive Breast CancerEarly-stage Breast CancerFirst-line Treatment of HER2-positive Recurrent or Metastatic Breast CancerHER2-negative Breast Cancer

Phase 1

Safety and Efficacy of SYHA1813 Single Agent or in Combination With Different Regimens in Unresectable Locally Advanced or Metastatic Solid Tumors.
Not yet recruitingNCT06682611
Shanghai Runshi Pharmaceutical Technology Co., LtdUnresectable Locally Advanced or Metastatic Solid Tumors
Start: 2024-11-13End: 2027-11-13Target: 380Updated: 2024-11-12

Phase 2

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
RecruitingNCT05582499
Fudan UniversityBreast Cancer, Breast Neoplasm, Breast Tumors +7
Start: 2022-11-01End: 2028-09-30Target: 716Updated: 2025-08-22
A Study to Compare the Efficacy and Safety of HB1801 to Taxotere in Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT05863325
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Start: 2023-06-27End: 2024-09-30Target: 80Updated: 2023-11-07
Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer
Not yet recruitingNCT06319313
Shanghai JMT-Bio Inc.Squamous Cell Non-small Cell Lung Cancer
Start: 2024-05-01End: 2027-12-01Target: 534Updated: 2024-03-20
A Study Comparing the Efficacy and Safety of HB1801 With Taxotere® in Advanced Breast Cancer
Not yet recruitingNCT07083505
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Advanced Breast Cancer
Start: 2025-08-15End: 2026-12-31Target: 60Updated: 2025-07-24
HB1801 Combined Treatment of HER2-positive Breast Cancer
Not yet recruitingNCT07116824
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.HER2-positive Breast Cancer
Start: 2025-09-15End: 2027-11-07Target: 80Updated: 2025-08-12

Phase 3

Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
RecruitingNCT05838066
Shanghai JMT-Bio Inc.First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Start: 2023-07-23End: 2027-12-31Target: 880Updated: 2025-05-30
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
RecruitingNCT06747338
Shanghai JMT-Bio Inc.Early or Locally Advanced HER2-positive Breast Cancer
Start: 2024-12-16End: 2027-12-16Target: 520Updated: 2025-04-24
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
Not yet recruitingNCT07441460
Shanghai JMT-Bio Inc.Resectable HER2-positive Breast Cancer
Start: 2026-03-07End: 2035-08-07Target: 1800Updated: 2026-03-02

Related Papers

Abstract GS1-04: HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial
Clinical Cancer Research2025-06-13
Abstract P2-11-06: Neoadjuvant chemotherapy plus camrelizumab vs. chemotherapy in patients with locally advanced immunomodulatory triple-negative breast cancer: a prospective, randomized, open-label, phase 2 trial
Clinical Cancer Research2025-06-13
Pyrotinib and Nab‐Paclitaxel in <scp>HER2</scp>‐Positive Breast Cancer (<scp>PANHER</scp> Trial): A Prospective, Single‐Arm, Phase <scp>II</scp> Trial
Cancer Science2025-04-22
Rational and trial design of FASCINATE-N: a prospective, randomized, precision-based umbrella trial
Therapeutic Advances in Medical Oncology2024-01-017 citations