T-DM1

Phase 3Small molecule

SSichuan Baili Pharmaceutical Co., Ltd.

T-DM1 is one of 76 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerUnknown status

HER2-Positive Breast CancerRecruiting

Brain MetastasesActive, not recruiting

Breast Cancer FemaleRecruiting

Breast CancerPhase 3

Unknown status

HER2-Positive Breast CancerPhase 3

Recruiting

Brain MetastasesPhase 2

Active, not recruiting

Breast Cancer FemalePhase 2

Recruiting

Competition

Competitive Landscape

706 competitors in Breast Cancer

#DrugCompanyPhaseTrials

T-DM1

SSichuan Baili Pharmaceutical Co., Ltd.

Phase 3

18 2

Adenocard

Astellas

Preclinical

2 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

Lexiscan

Astellas

Preclinical

1 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

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-Positive Breast Cancer

NCT02326974

Phase 3Recruiting

HER2-Positive Breast Cancer

NCT07673029

Phase 3Active, not recruiting

Breast Cancer

NCT06968585

Clinical

Trials by Indication[1]

Breast Cancer18 trials

ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer

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

T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer

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

Show 15 more trials

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 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

Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer

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

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

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

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

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

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

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

HER2-positive Breast Cancer5 trials

A Phase III, Multicenter, Open-label, Randomized Study to Compare DB-1303 Versus T-DM1 in Patients With HER2-positive Unresectable/Metastatic Breast Cancer Who Have Been Treated With Trastuzumab and a Taxane (Dynasty-Breast01)

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

The Impact of HER2 Heterogeneity on the Treatment of Early-stage HER2-positive Breast Cancer: a Phase II Study of T-DM1 in Combination With Pertuzumab in the Preoperative Setting

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT02326974·164 enrolled

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

Show 2 more trials

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

DM11 trial

Trastuzumab & Pertuzumab Followed by T-DM1 in MBC

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

2 more indications

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 Cancer18 trials

HER2-positive Breast Cancer5 trials

DM11 trial

Pembrolizumab1 trial

Neoadjuvant1 trial

Breast Cancer Female1 trial

Brain Metastases1 trial

References

Drug Info

Quick Facts

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