Disitamab Vedotin

Phase 3Antibody–drug conjugate

Disitamab Vedotin is an antibody–drug conjugate that works as a Receptor Tyrosine-Protein Kinase Erbb-2 Binding Agent; Tubulin Disrupting Agent.[2] It is being investigated across 22 indications, with its most advanced program in Phase 3.[1]

Disitamab Vedotin is one of 477 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

476

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerRecruiting

Breast NeoplasmsActive, not recruiting

Non Muscle Invasive Bladder CancerActive, not recruiting

MibcRecruiting

Bladder Urothelial CarcinomaRecruiting

Carcinoma, Non-Small-Cell LungActive, not recruiting

GlandNot yet recruiting

Advanced Breast CancerRecruiting

Efficacy and SafetyRecruiting

Locally Advanced Solid TumorRecruiting

Breast CancerPhase 3

Recruiting

Breast NeoplasmsPhase 2

Active, not recruiting

Non Muscle Invasive Bladder CancerPhase 2

Active, not recruiting

MibcPhase 3

Recruiting

Bladder Urothelial CarcinomaPhase 2

Recruiting

Carcinoma, Non-Small-Cell LungPhase 2

Active, not recruiting

GlandPhase 2

Not yet recruiting

Advanced Breast CancerPhase 2

Recruiting

Efficacy and SafetyPhase 2

Recruiting

Locally Advanced Solid TumorPhase 1

Recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Disitamab Vedotin

Pfizer

Phase 3

12 2

Adenocard

Astellas

Preclinical

2 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Vfend

PPrism Pharmaceuticals

Preclinical

—6

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 7

Tianeptine

Pfizer

Preclinical

1 8

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 9

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 10

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Breast Cancer

NCT06178159

Phase 2Not yet recruiting

Locally Advanced or Metastatic NSCLC

NCT06185400

Q1 2027

Phase 2Recruiting

Breast Cancer

NCT07446452

Phase 2Active, not recruiting

Non Muscle Invasive Bladder Cancer

NCT06187506

Phase 1Recruiting

Locally Advanced Solid Tumor

NCT05940896

Q3 2027

Phase 2Not yet recruiting

Gastric Cancer

NCT06492317

Clinical

Trials by Indication[1]

Breast Cancer12 trials

RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07065435·74 enrolled

DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer

Recruiting·RRemeGen Co., Ltd.·Phase 2·NCT06178159·40 enrolled

Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT07446452·37 enrolled

Show 9 more trials

Disitamab Vedotin(RC48) Combined With Penpulimab(AK105) for Neoadjuvant Treatment of HER2-low Breast Cancer

Unknown status·WWest China Hospital·Phase 2·NCT05726175·20 enrolled

RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure

Not yet recruiting·FFudan University·Phase 2/3·NCT07366840·268 enrolled

Disitamab Vedotin (RC48-ADC) in Breast Cancer

Recruiting·RRenJi Hospital··NCT05851677·45 enrolled

Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer

Recruiting·RRemeGen Co., Ltd.·Phase 2·NCT06642545·40 enrolled

RC48-ADC in HER2-low Advanced Breast Cancer

Recruiting·RRenJi Hospital·N/A·NCT05831878·36 enrolled

Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer

Withdrawn·RRemeGen Co., Ltd.·Phase 2·NCT06105008

Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 3·NCT05904964·288 enrolled

Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 3·NCT06278870·312 enrolled

A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER

Active, not recruiting· Pfizer logo

Pfizer·Preclinical·NCT06966453·74 enrolled

Gastric Cancer5 trials

Posterior-line Treatment With Disitamab Vedotin Plus PD-1 in Advanced HER2-low Expressing Gastric Cancer

Unknown status·SShanghai East Hospital·Phase 1·NCT06078982·39 enrolled

Conversion Therapy of Disitamab Vedotin Combined With Sintilimab and S-1 in HER2 Overexpression Gastric Cancer

Unknown status·TTianjin Medical University Cancer Institute and Hospital·Phase 2·NCT05627414·30 enrolled

RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer

Not yet recruiting·TThe First Affiliated Hospital of Zhengzhou University·Phase 2·NCT06492317·20 enrolled

Show 2 more trials

Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer

Recruiting·FFudan University·Phase 2·NCT07194005·30 enrolled

First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer

Active, not recruiting·QQilu Hospital of Shandong University·Phase 2·NCT05586061·55 enrolled

Urothelial Carcinoma4 trials

Probiotics in Advanced Urothelial Carcinoma

Recruiting·SSun Yat-sen University·Phase 2·NCT06904573·222 enrolled

A Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin Combined With PD-1 Inhibitor and Radiotherapy as Bladder-preserving Therapy in Patients With Localized HER2-high Expressing Muscle-invasive Bladder Urothelial Carcinoma Following Maximal Transurethral Resection

Not yet recruiting·RRenJi Hospital·Phase 2·NCT07142200·45 enrolled

An Open-label, Randomized, Controlled Phase 3 Study of Disitamab Vedotin in Combination With Pembrolizumab Versus Chemotherapy in Subjects With Previously Untreated Locally Advanced or Metastatic Urothelial Carcinoma That Expresses HER2 (IHC 1+ and Greater)

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT05911295·412 enrolled

Show 1 more trial

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

Recruiting· Pfizer logo

Pfizer·Phase 2·NCT04879329·372 enrolled

Gastroesophageal Junction Adenocarcinoma3 trials

DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy

Recruiting·RRemeGen Co., Ltd.·Phase 2/3·NCT06221748·90 enrolled

Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.

Recruiting·RRemeGen Co., Ltd.·Phase 2·NCT06155383·90 enrolled

A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.

Recruiting·RRemeGen Co., Ltd.·Phase 3·NCT07315750·555 enrolled

Prostate Cancer2 trials

Efficacy and Safety of Disitamab Vedotin Plus Abiraterone for Metastatic Castration-Resistant Prostate Cancer：a Phase II Study

Recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT07093866·20 enrolled

Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer

Recruiting·RRemeGen Co., Ltd.·Phase 2·NCT06227156·40 enrolled

22 more indications

Bladder Urothelial Carcinoma2 trials

A Prospective, Multicenter, Randomized Controlled Study of Disitamab Vedotin Plus Toripalimab With or Without Pelvic Lymph Node Dissection for Bladder-Sparing Treatment in Patients With cT2-3N0M0 Bladder Urothelial Carcinoma

Not yet recruiting·TTianjin Medical University Second Hospital·Preclinical·NCT07756008·114 enrolled

Study on Immunotherapy Enhancement Strategies for Muscle-invasive Bladder Cancer

Recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT07717242·80 enrolled

Pancreatic Cancer1 trial

A Study of the Treatment of Disitamab Vedotin in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT06233864·63 enrolled

Targeted Therapy1 trial

Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC

Not yet recruiting·Cchenxu·Phase 2·NCT07474064·146 enrolled

Bladder Cancer1 trial

Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

Not yet recruiting·SSun Yat-sen University·Phase 1/2·NCT06957561·30 enrolled

Advanced Solid Tumors1 trial

Real-world Study of HER2-overexpressed Advanced Solid Tumors After Progression of First-line Standard Therapy

Unknown status·SShen Lin··NCT05649163·306 enrolled

Locally Advanced or Metastatic NSCLC1 trial

RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations

Not yet recruiting·—·Phase 2·NCT06185400·108 enrolled

First-line Treatment1 trial

Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients

Recruiting·ZZhejiang Cancer Hospital·Phase 1/2·NCT06650332·90 enrolled

Cervical Cancer1 trial

A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer

Recruiting·RRemeGen Co., Ltd.·Phase 2·NCT06155396·116 enrolled

Not yet recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07159217·65 enrolled

Metastatic Colorectal Cancer1 trial

Pembrolizumab and Disitamab Vedotin in HER2-expressing Metastatic Colorectal Cancer

Unknown status·SShanghai Zhongshan Hospital·Phase 2·NCT05333809·30 enrolled

Locally Advanced Solid Tumor1 trial

RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression

Recruiting·RRemeGen Co., Ltd.·Phase 1·NCT05940896·24 enrolled

Bladder Carcinoma1 trial

Disitamab Vedotin Combined With Tislelizumab for Her2 Overexpressing High-Risk Non-Muscle-Invasive Urothelial Bladder Carcinoma Which is Not Completely Resectable

Unknown status·TTianjin Medical University Second Hospital·Phase 2·NCT05495724·176 enrolled

Efficacy and Safety1 trial

A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery

Recruiting·PPeking University First Hospital·Phase 2·NCT06210490·60 enrolled

HER2-positive Gastric Cancer1 trial

A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)

Recruiting·QQilu Hospital of Shandong University·Phase 2·NCT06730373·110 enrolled

Advanced Breast Cancer1 trial

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer：A Prospective, Open-label, Phase 2 Trial

Recruiting·FFudan University·Phase 2·NCT06649331·160 enrolled

Gland1 trial

A Single-Arm, Prospective Clinical Study of Sintilimab Combined With Disitamab Vedotin as Neoadjuvant Therapy for Locally Advanced Eyelid Sebaceous Gland Carcinoma

Not yet recruiting·WWest China Hospital·Phase 2·NCT07740993·25 enrolled

Breast Neoplasms1 trial

A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors

Active, not recruiting· Pfizer logo

Pfizer·Phase 2·NCT06157892·54 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A Phase 2 Basket Study of Disitamab Vedotin in Adult Subjects With Previously Treated, Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2

Active, not recruiting· Pfizer logo

Pfizer·Phase 2·NCT06003231·120 enrolled

Non Muscle Invasive Bladder Cancer1 trial

A Prospective, Open, Single-center Clinical Study of Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer

Active, not recruiting·FFudan University·Phase 2·NCT06187506·20 enrolled

Mibc1 trial

Neoadjuvant RC48 Plus Gemcitabine for HER2 1~3+ MIBC: A Prospective, Multicenter, Randomized, Controlled, Non-inferiority Study (GUARD-02)

Recruiting·ZZhiquan Hu·Phase 3·NCT07693959·170 enrolled

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Disitamab Vedotin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Disitamab Vedotin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Disitamab Vedotin. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Receptor Tyrosine-Protein Kinase Erbb-2 Binding Agent; Tubulin Disrupting Agent[2]
Modality: Antibody–drug conjugate[2]
Highest Phase: Phase 3[1]
Company: Pfizer

Disitamab Vedotin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Trials by Indication[1]

Breast Cancer12 trials

Gastric Cancer5 trials

Urothelial Carcinoma4 trials

Gastroesophageal Junction Adenocarcinoma3 trials

Prostate Cancer2 trials

Bladder Urothelial Carcinoma2 trials

Pancreatic Cancer1 trial

Targeted Therapy1 trial

Bladder Cancer1 trial

Advanced Solid Tumors1 trial

Locally Advanced or Metastatic NSCLC1 trial

First-line Treatment1 trial

Cervical Cancer1 trial

Colorectal Cancer1 trial