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IBI354

DRUG4 trials

Sponsors

Fudan University, Innovent Biologics (Suzhou) Co. Ltd., Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.

Conditions

Breast CancerBreast NeoplasmBreast TumorsEarly-stage Breast CancerFallopian Tube CancerHER2-negative Breast CancerHER2-positive Breast CancerHormone Receptor Negative Tumor

Phase 1

A First-in-human Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors
RecruitingNCT05636215
Innovent Biologics (Suzhou) Co. Ltd.Locally Advanced Unresectable or Metastatic Solid Tumors
Start: 2023-04-04End: 2025-10-31Target: 368Updated: 2025-03-20

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: 2029-09-01Target: 716Updated: 2026-05-28

Phase 3

Study of IBI354 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
RecruitingNCT06834672
Innovent Biologics (Suzhou) Co. Ltd.Fallopian Tube Cancer, Ovarian, Primary Peritoneal
Start: 2025-03-17End: 2029-11-28Target: 450Updated: 2025-04-13
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
RecruitingNCT07377643
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.HER2-positive Breast Cancer
Start: 2026-02-10End: 2030-05-31Target: 540Updated: 2026-02-25

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
IBI354 (anti-HER2 antibody-drug conjugate [ADC]) in patients (pts) with HER2-positive breast cancer (BC) and other solid tumors: Updates from a phase 1 study.
Journal of Clinical Oncology2025-05-281 citations
IBI354, an anti-HER2 antibody-drug conjugate, in patients with locally advanced unresectable or metastatic ovarian cancers: Updated results from a phase I trial.
Journal of Clinical Oncology2025-05-281 citations
Rational and trial design of FASCINATE-N: a prospective, randomized, precision-based umbrella trial
Therapeutic Advances in Medical Oncology2024-01-017 citations