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 445 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

444

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaRecruiting

Biliary Tract CancerNot yet recruiting

Breast CancerNot yet recruiting

Pancreatic CancerNot yet recruiting

Prostate CancerRecruiting

Bladder CancerNot yet recruiting

Gastric CancerUnknown status

Cervical CancerRecruiting

Non Muscle Invasive Bladder CancerActive, not recruiting

Advanced Breast CancerRecruiting

Gastroesophageal Junction AdenocarcinomaPhase 3

Recruiting

Biliary Tract CancerPhase 2

Not yet recruiting

Breast CancerPhase 3

Not yet recruiting

Pancreatic CancerPhase 2

Not yet recruiting

Prostate CancerPhase 2

Recruiting

Bladder CancerPhase 2

Not yet recruiting

Gastric CancerPhase 2

Unknown status

Cervical CancerPhase 2

Recruiting

Non Muscle Invasive Bladder CancerPhase 2

Active, not recruiting

Advanced Breast CancerPhase 2

Recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Disitamab Vedotin

Pfizer

Phase 3

12 2

Blenoxane

Bristol-Myers Squibb

Preclinical

1 3

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 4

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 5

Tianeptine

Pfizer

Preclinical

1 6

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 7

Bisphosphonate

Amgen

Preclinical

2 8

Tc99m Sestamibi

MM.D. Anderson Cancer Center

Preclinical

2 9

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 10

Perflutren Lipid Microsphere

IImaRx Therapeutics

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

Q2 2027

Phase 2Recruiting

Non Muscle Invasive Bladder Cancer

NCT07646145

Clinical

Trials by Indication[1]

Breast Cancer12 trials

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

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

Show 9 more trials

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

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

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

RC48-ADC in HER2-low Advanced Breast Cancer

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

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

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

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

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

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

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

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

Show 2 more 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

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

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

Probiotics in Advanced Urothelial Carcinoma

Recruiting·SSun Yat-sen University·Phase 2·NCT06904573·222 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 Adenocarcinoma2 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

Bladder Cancer2 trials

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

Efficacy and Safety of Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer: A Single-Arm Clinical Study

Not yet recruiting·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 1·NCT07853053·20 enrolled

24 more indications

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

Non Muscle Invasive Bladder Cancer2 trials

Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Medium-high Risk Non-Muscle-Invasive Bladder Cancer: A Phase II Clinical Trial

Recruiting·SShanxi Province Cancer Hospital·Phase 2·NCT07646145·50 enrolled

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

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

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

Biliary Tract Cancer1 trial

Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer

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

Colorectal Cancer1 trial

Disitamab Vedotin Combined With Tislelizumab in Advanced HER2 Positive Colorectal Cancer

Unknown status·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT05493683·29 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