T-DM1

Phase 3Small molecule

SSichuan Baili Pharmaceutical Co., Ltd.

T-DM1 is one of 70 small molecule programs targeting Brain Metastases. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Brain MetastasesActive, not recruiting

Breast Cancer FemaleRecruiting

HER2Active, not recruiting

HER2-Positive Breast CancerActive, not recruiting

Breast CancerActive, not recruiting

Brain MetastasesPhase 2

Active, not recruiting

Breast Cancer FemalePhase 2

Recruiting

HER2Phase 2

Active, not recruiting

HER2-Positive Breast CancerPhase 3

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

T-DM1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

19 2

Zolymbus

AbbVie

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Duragesic-100

CCephalon

Preclinical

2 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 7

Acupan

YYonsei University

Preclinical

1 8

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

1 9

Tricor

JJagotec

Preclinical

1 10

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Active, not recruiting

Breast Cancer

NCT03587740

Q4 2027

Phase 2Active, not recruiting

Brain Metastases

NCT05323955

Phase 2Active, not recruiting

Breast Cancer

NCT04398914

Q1 2028

Phase 2Active, not recruiting

HER2

NCT02326974

Phase 3Recruiting

HER2-Positive Breast Cancer

NCT07673029

Phase 3Active, not recruiting

Breast Cancer

NCT06968585

Clinical

Trials by Indication[1]

Breast Cancer19 trials

A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer

Terminated· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 1·NCT03429101·6 enrolled

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

Active, not recruiting·DDualityBio Inc.·Phase 3·NCT06265428·228 enrolled

Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

Recruiting·UUniversity of Virginia·Phase 2/3·NCT05288777·45 enrolled

Show 16 more trials

HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1

Completed·JJules Bordet Institute·Phase 2·NCT01565200·90 enrolled

T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

Completed·UUniversity of Arizona·Phase 2·NCT03530696·55 enrolled

Pyrotinib, Trastuzumab, Pertuzumab and Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer

Active, not recruiting·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT04398914·216 enrolled

A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy

Active, not recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 3·NCT06968585·365 enrolled

Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 3·NCT05429684·120 enrolled

ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer

Active, not recruiting·—·Phase 2·NCT03587740·82 enrolled

A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT04622319·1,600 enrolled

T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer

Completed·JJenny C. Chang, MD·Phase 1·NCT02073916·24 enrolled

Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

Terminated·UUniversity of Kansas Medical Center·Phase 1/2·NCT03709082·3 enrolled

T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT03190967·12 enrolled

A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer

Completed·NNSABP Foundation Inc·Phase 1/2·NCT02236000·49 enrolled

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

Recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06830889·1,450 enrolled

A Study of HER2+ Breast Cancer Patients With Active Brain Metastases Treated With Afatinib & T-DM1 vs. T-DM1 Alone

Unknown status·Xxuexin he·Phase 2·NCT04158947·130 enrolled

An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.

Completed·—·Phase 1/2·NCT02657343·25 enrolled

A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.

Completed·WWest German Study Group·Phase 2·NCT01745965·380 enrolled

A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer

Completed· Pfizer logo

Pfizer·Phase 1·NCT01983501·57 enrolled

HER2-positive Breast Cancer3 trials

A Randomized Controlled Phase III Clinical Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Active, not recruiting·SSichuan Baili Pharmaceutical Co., Ltd.·Phase 3·NCT06316531·274 enrolled

Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT03975647·466 enrolled

A Phase III, Multicenter, Open-label, Randomized Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane

Recruiting·GGeneQuantum Healthcare (Suzhou) Co., Ltd.·Phase 3·NCT07673029·228 enrolled

Pembrolizumab1 trial

A Study Of Pembrolizumab In Combination With Trastuzumab-DM1

Completed·—·Phase 1·NCT03032107·20 enrolled

Neoadjuvant1 trial

Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel

Completed·TThe Methodist Hospital Research Institute·Phase 2·NCT02073487·32 enrolled

DM11 trial

Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

Completed·SSwiss Cancer Institute·Phase 2·NCT01835236·208 enrolled

3 more indications

HER21 trial

T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA

Active, not recruiting·—·Phase 2·NCT02326974·164 enrolled

Breast Cancer Female1 trial

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study

Recruiting·DDana-Farber Cancer Institute·Phase 2·NCT06439693·72 enrolled

Brain Metastases1 trial

Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

Active, not recruiting·CCarey Anders, M.D.·Phase 2·NCT05323955·48 enrolled

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for T-DM1. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — T-DM1 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for T-DM1. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Sichuan Baili Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: SSichuan Baili Pharmaceutical Co., Ltd.

T-DM1

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Breast Cancer19 trials

HER2-positive Breast Cancer3 trials

Pembrolizumab1 trial

Neoadjuvant1 trial

DM11 trial

HER21 trial

Breast Cancer Female1 trial

Brain Metastases1 trial

References

Drug Info

Quick Facts

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