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 17 indications, with its most advanced program in Phase 3.[1]

Disitamab Vedotin is one of 431 small molecule programs targeting Gastroesophageal Junction Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

430

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastroesophageal Junction AdenocarcinomaActive, not recruiting

Colorectal NeoplasmActive, not recruiting

Breast NeoplasmActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Biliary Tract CancerActive, not recruiting

Breast CancerActive, not recruiting

Colorectal CancerActive, not recruiting

Pancreatic CancerActive, not recruiting

Prostate CancerActive, not recruiting

Ovarian CancerActive, not recruiting

Gastroesophageal Junction AdenocarcinomaPhase 2

Active, not recruiting

Colorectal NeoplasmPhase 2

Active, not recruiting

Breast NeoplasmPhase 1

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

Biliary Tract CancerPhase 2

Active, not recruiting

Breast CancerPhase 3

Active, not recruiting

Colorectal CancerPhase 2

Active, not recruiting

Pancreatic CancerPhase 2

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Ovarian CancerPhase 2

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Disitamab Vedotin

Pfizer

Phase 3

12 2

Tecentriq

Roche

Preclinical

36 3

Adriamycin

GGynecologic Oncology Group

Preclinical

87 4

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 5

MS Contin

Merck & Co.

Preclinical

2 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 8

Spravato

WWim Janssens

Preclinical

2 9

Acupan

YYonsei University

Preclinical

1 10

Paracetamol

GSK

Preclinical

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

Timeline

Expected Milestones

Q3 2026

N/ARecruiting

Breast Cancer

NCT05831878

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 2Recruiting

Bladder Cancer

NCT06187506

Phase 1Recruiting

Locally Advanced Solid Tumor

NCT05940896

Clinical

Trials by Indication[1]

Breast Cancer12 trials

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 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) 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

Show 9 more trials

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 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

Disitamab Vedotin (RC48-ADC) in Breast Cancer

Recruiting·RRenJi Hospital··NCT05851677·45 enrolled

RC48-ADC in HER2-low Advanced Breast Cancer

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

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

A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer

Recruiting· Pfizer logo

Pfizer·Phase 1/2·NCT06966453·100 enrolled

Gastric Cancer6 trials

First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

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

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

Recruiting·FFudan University·Phase 2·NCT07194005·30 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

Show 3 more trials

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

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

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

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

Urothelial Carcinoma2 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

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

17 more indications

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

Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer

Recruiting·FFudan University·Phase 2·NCT06187506·20 enrolled

Urothelial Cancer2 trials

A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

Recruiting· Pfizer logo

Pfizer·Phase 2·NCT04879329·372 enrolled

Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT05911295·412 enrolled