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Drug

Disitamab vedotin

Approved medicine
ClassTubulin disrupting agentResearchOngoing clinical research

Also known as RC48-ADC, Vedicitumomab, DisitamabVedotin.

RxNorm2622201ChEMBLCHEMBL5095273UNIIRB3U3A1S27
1
Research papers
39
Active clinical trials
16
Protein targets
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

An Open-label, Multicohort Phase I/II Study of the Cadonilimab (AK104) Combination Regimen as First-line Treatment for HER2-expressing, Unresectable Locally Advanced or Metastatic Gastric (G) or Gastroesophageal Junction (GEJ) Cancer

Clinical trial2026-08-10Primary completion · ClinicalTrials.gov

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

Clinical trial2026-07-22Results expected Q3 2029 · ClinicalTrials.gov

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

Clinical trial2026-07-22Results expected Q4 2026 · ClinicalTrials.gov

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

Clinical trial2026-07-20Status changed to Active, not recruiting · ClinicalTrials.gov

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

Clinical trial2026-07-09Results expected Q3 2028 · ClinicalTrials.gov

A Prospective, Single-center, Phase II Clinical Study of First-line Treatment for HER2 (Human Epidermal Growth Factor Receptor 2) Overexpressing Advanced Gastric Cancer With Disitamab Vedotin in Combination With Cadonilimab

Clinical trial2026-07-06Primary completion · ClinicalTrials.gov

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

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

First-Line Disitamab Vedotin, Tislelizumab, and S-1 in HER2-Overexpressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-Arm, Phase II Trial

Clinical trial2026-06-26Trial news · Journal of Clinical Oncology

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)

Clinical trial2026-06-15Results expected Q1 2027 · ClinicalTrials.gov

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

Clinical trial2026-06-12Results expected Q2 2027 · ClinicalTrials.gov

A Phase II, Multicenter, Open-Label Neoadjuvant Study to Evaluate the Safety and Efficacy of Disitamab Vedotin in Combination With Pertuzumab With or Without Toripalimab for HER2 Positive Breast Cancer

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

Efficacy and Safety of Disitamab Vedotin in Patients With Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Urothelial Carcinoma: A Combined Analysis of Two Phase II Clinical Trials.

Research2023-11-21Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Disitamab vedotin
Aliases & brands
RC48-ADCVedicitumomabDisitamabVedotin
RxNorm CUI
2622201
ChEMBL ID
CHEMBL5095273
UNII
RB3U3A1S27
Primary mechanism
Tubulin disrupting agent

Pharmacology & targets

16 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tubulin beta-4B chain
TUBB4B · P68371
DISRUPTING AGENTTubulin disrupting agent
Tubulin beta-1 chain
TUBB1 · Q9H4B7
DISRUPTING AGENTTubulin disrupting agent
Tubulin alpha-3C chain
TUBA3C · P0DPH7
DISRUPTING AGENTTubulin disrupting agent
Tubulin alpha-4A chain
TUBA4A · P68366
DISRUPTING AGENTTubulin disrupting agent
Tubulin beta-3 chain
TUBB3 · Q13509
DISRUPTING AGENTTubulin disrupting agent
Tubulin alpha-1A chain
TUBA1A · Q71U36
DISRUPTING AGENTTubulin disrupting agent
Tubulin beta-4A chain
TUBB4A · P04350
DISRUPTING AGENTTubulin disrupting agent
Tubulin beta-8 chain
TUBB8 · Q3ZCM7
DISRUPTING AGENTTubulin disrupting agent
Tubulin beta chain
TUBB · P07437
DISRUPTING AGENTTubulin disrupting agent
Tubulin alpha-1B chain
TUBA1B · P68363
DISRUPTING AGENTTubulin disrupting agent
Tubulin alpha-1C chain
TUBA1C · Q9BQE3
DISRUPTING AGENTTubulin disrupting agent
Tubulin alpha-3E chain
TUBA3E · Q6PEY2
DISRUPTING AGENTTubulin disrupting agent
Tubulin beta-2A chain
TUBB2A · Q13885
DISRUPTING AGENTTubulin disrupting agent
Tubulin beta-2B chain
TUBB2B · Q9BVA1
DISRUPTING AGENTTubulin disrupting agent
Tubulin beta-6 chain
TUBB6 · Q9BUF5
DISRUPTING AGENTTubulin disrupting agent
Receptor tyrosine-protein kinase erbB-2
ERBB2 · P04626
BINDING AGENTReceptor tyrosine-protein kinase erbB-2 binding agent

Clinical trials

70 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
70
registered trials across all phases
LATEST COMPLETION 2023
39
Active studies
34
Recruiting
13
Late-stage (III+)
6
Completed
25
Discontinued
PHASE DISTRIBUTIONn = 70
Phase 15Phase 1 / 25Phase 247Phase 2 / 34Phase 38Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Disitamab Vedotin in Combination With Pyrotinib Versus THP in the First-line Treatment for HER2-positive Advanced Breast Cancer, a Multicentre, Randomized, Double-blind Controlled, Phase III Trial

RecruitingPH IIISun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityn=3122031

A Prospective, Randomized Controlled Study of Perioperative Disitamab Vedotin Plus Immunotherapy Versus Chemotherapy Plus Immunotherapy in Patients With Resectable HER2-Expressing Muscle-Invasive Bladder Cancer (HOPE-07-MIBC Study)

Not yet recruitingPH II/IIIWest China Hospitaln=2402030

A Randomized Controlled Phase III Study to Evaluate the Combination of Disitamab Vedotin, Trastuzumab, and Tislelizumab Versus Chemotherapy (CAPOX) Combined With Trastuzumab With or Without Pembrolizumab as First-Line Treatment for Advanced Gastric/Gastroesophageal Junction Adenocarcinoma With HER2-high Expression

RecruitingPH IIIRemeGen Co., Ltd.n=5552030

Disitamab Vedotin or Endocrine Therapy for Patients With Metastatic Breast Cancer With Hormone Receptor-positive and HER2-low-expression

RecruitingPH IIISun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityn=2882030

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

RecruitingPH IIIZhiquan Hun=1702029

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer

CompletedPH IIRemeGen Co., Ltd.n=642023

An Open-label, Single-arm, Single-center, Phase II Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in Subjects With HER2-negative Metastatic or Unresectable Urothelial Cancer

CompletedPH IIRemeGen Co., Ltd.n=192023

A Multicenter, Open Label，Single Arm，Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in HER2 Overexpressing Local Advanced or Metastatic Gastric Cancer

CompletedPH IIRemeGen Co., Ltd.n=1272020

A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive

CompletedPH IRemeGen Co., Ltd.n=242020

A Tolerance, Safety and Pharmacokinetic Ascending Dose Phase I Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive Malignant in Advanced Malignant Solid Tumors

CompletedPH IRemeGen Co., Ltd.n=572019

A Multicenter, Open Label，Single Arm，Phase II Study to Evaluate the Effect and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer

CompletedPH IIRemeGen Co., Ltd.n=432018

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes6
Antibodies, Monoclonal1Carcinoma, Transitional Cell1Erb-b2 Receptor Tyrosine Kinases1Neutropenia1Oligopeptides1Urinary Bladder Neoplasms1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Fang J1
  • Guo H1
  • Guo J1
  • Han W1
  • He Z1
  • Hu C1
  • Hu Y1
  • Ji Z1
Leading institutions
free-text, unnormalised
  • Anhui Provincial Cancer Hospital1
  • Cancer Center1
  • Chinese Academy of Medical Sciences and Peking Union Medical College1
  • Chinese PLA General Hospital1
  • Chongqing University Cancer Hospital and Chongqing Cancer Institute and Chongqing Cancer Hospital1
  • Department of Cancer Centre1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials