Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist

Compiled from ClinicalTrials.gov registry records · Last verified 25 Sep 2026 · Editorial standards

At a glance

Disitamab Vedotin is named as an intervention in 53 current clinical trials in our China, USA, UK and Ireland registers. 35 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is RemeGen Co., Ltd (11). The most-studied condition is Breast Cancer.

Trials by status

Recruiting3566%
Not yet open1121%
Active, closed713%

Trials by phase

Phase 23464%
Phase 1/2713%
Phase 359%
Phase 2/336%
Not applicable24%
Phase EARLY_PHASE112%
Phase 112%

Clinical trials of Disitamab Vedotin

53 trials

Study	Phase	Status	Lead sponsor	Registers
Exploratory Study on the Safety and Efficacy of Disitamab Vedotin in Combination with Anlotinib Hydrochloride for the Treatment of HER-2-expressing Recurrent Platinum-resistant Ovarian Cancer. NCT06660511 · ClinicalTrials.gov ↗ · Ovarian Cancer Recurrent	Phase EARLY_PHASE1	Recruiting	Second Xiangya Hospital of Central South University	China
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma NCT05302284 · ClinicalTrials.gov ↗ · Urothelial Carcinoma, HER2-expressing	Phase 3	Recruiting	RemeGen Co., Ltd.	China
Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial) NCT05904964 · ClinicalTrials.gov ↗ · HR Positive/HER2 Low Expression Metastatic Breast Cancer	Phase 3	Recruiting	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	China
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. NCT07315750 · ClinicalTrials.gov ↗ · Gastric Carcinoma	Phase 3	Recruiting	RemeGen Co., Ltd.	China
Neoadjuvant RC48 Plus Gemcitabine in HER2-Expressing MIBC NCT07693959 · ClinicalTrials.gov ↗ · MIBC	Phase 3	Recruiting	Zhiquan Hu	China
DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy NCT06221748 · ClinicalTrials.gov ↗ · Gastric Cancer, Gastroesophageal Junction Adenocarcinoma	Phase 2/3	Recruiting	RemeGen Co., Ltd.	China
A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2 NCT04879329 · ClinicalTrials.gov ↗ · Urothelial Carcinoma	Phase 2	Recruiting	Seagen, a wholly owned subsidiary of Pfizer	UK, USA
Efficacy and Safety of Tislelizumab in Combination With Disitamab-vedotin as Neoadjuvant Therapy for HER2-positive High-risk Upper Tract Urothelial Carcinoma (UTUC) NCT05837806 · ClinicalTrials.gov ↗ · Neoadjuvant Immunotherapy	Phase 2	Recruiting	Tianjin Medical University Second Hospital	China
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects NCT05943379 · NMIBC	Phase 2	Recruiting	RemeGen Co., Ltd.	China
Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma. NCT06155383 · ClinicalTrials.gov ↗ · Gastric Cancer, Gastroesophageal Junction Adenocarcinoma	Phase 2	Recruiting	RemeGen Co., Ltd.	China
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer NCT06178159 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 2	Recruiting	RemeGen Co., Ltd.	China
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 NCT06210490 · ClinicalTrials.gov ↗ · Upper Urinary Tract Urothelial Carcinoma	Phase 2	Recruiting	Peking University First Hospital	China
To Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With Toripalimab Sequential Chemotherapy as Neoadjuvant Treatment in Patients With HR-positive, HER2-low Breast Cancer NCT06389006 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 2	Recruiting	RemeGen Co., Ltd.	China
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer NCT06642545 · ClinicalTrials.gov ↗ · Breast Cancer	Phase 2	Recruiting	RemeGen Co., Ltd.	China
Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer NCT06649331 · ClinicalTrials.gov ↗ · Advanced Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer (TNBC)	Phase 2	Recruiting	Fudan University	China
First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2) NCT06730373 · ClinicalTrials.gov ↗ · HER2-positive Gastric Cancer, Metastatic Gastric Cancer, Unresectable Gastric Carcinoma	Phase 2	Recruiting	Qilu Hospital of Shandong University	China
Neoadjuvant Envafolimab Plus Disitamab Vedotin and Carboplatin in Resectable HER2-Mutant Non-Small-Cell Lung Cancer NCT06734182 · ClinicalTrials.gov ↗ · Non-small Cell Lung Cancer	Phase 2	Recruiting	Guangdong Provincial People's Hospital	China
Disitamab Vedotin in Combination with Tislelizumab and Bevacizumab in a Phase II Clinical Study of Locally Advanced or Metastatic Non-small Cell Lung Cancer with HER2 Mutation/amplification/expression NCT06749860 · ClinicalTrials.gov ↗ · Lung Cancer	Phase 2	Recruiting	Shanghai Pulmonary Hospital, Shanghai, China	China
A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum NCT06791070 · ClinicalTrials.gov ↗ · Paget Disease, Extramammary, Scrotum Disease	Phase 2	Recruiting	Fujian Medical University Union Hospital	China
Probiotics in Advanced Urothelial Carcinoma NCT06904573 · ClinicalTrials.gov ↗ · Advanced Urothelial Carcinoma, Probiotics, Immunotherapy	Phase 2	Recruiting	Sun Yat-sen University	China
RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study NCT07065435 · ClinicalTrials.gov ↗ · HER2 + Breast Cancer	Phase 2	Recruiting	The First Affiliated Hospital with Nanjing Medical University	China
A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease NCT07117851 · ClinicalTrials.gov ↗ · Extramammary Paget Disease, Scrotum Disease	Phase 2	Recruiting	Fudan University	China
Conversion Therapy With RC48, Sintilimab, and SOX for HER2 1+/2+ Unresectable Gastric Cancer NCT07194005 · ClinicalTrials.gov ↗ · Gastric Cancer	Phase 2	Recruiting	Fudan University	China
Efficacy and Safety of Distamab Vedotin Combined With Carboplatin for Advanced Ovarian Cancer in the First Line Treatment NCT07285941 · ClinicalTrials.gov ↗ · Ovarian Cancer, HER2	Phase 2	Recruiting	Zhejiang Cancer Hospital	China
Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study NCT07446452 · ClinicalTrials.gov ↗ · HER2-low Breast Cancer	Phase 2	Recruiting	The First Affiliated Hospital with Nanjing Medical University	China
Disitamab Vedotin Combined With SOX Regimen Versus SOX Alone as Adjuvant Therapy for HER2-Moderate/High Expressing Stage Ⅲ Gastric Cancer: A Prospective, Multicenter, Randomized, Phase Ⅱ Clinical Trial NCT07474324 · ClinicalTrials.gov ↗ · GC/GEJC	Phase 2	Recruiting	The First Affiliated Hospital with Nanjing Medical University	China
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer NCT07646145 · ClinicalTrials.gov ↗ · Non-Muscle-Invasive Bladder Cancer (NMIBC)	Phase 2	Recruiting	Shanxi Province Cancer Hospital	China
Sun Yat-Sen Treatment Strategy for Enhancing Response in Muscle-invasive Bladder Cancer NCT07717242 · ClinicalTrials.gov ↗ · Bladder Urothelial Carcinoma, Bladder Cancer	Phase 2	Recruiting	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	China
RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2 NCT05403242 · ClinicalTrials.gov ↗ · Advanced Gastroesophageal Adenocarcinoma	Phase 1/2	Recruiting	Chinese PLA General Hospital	China
To Evaluate the Safety, Efficacy, and Pharmacokinetics of Intravesical Instiliations of Disitamab Vedotin in Patients With High-risk Non-muscular Invasive Bladder Cancer (NMIBC) That Express HER2 NCT06378242 · ClinicalTrials.gov ↗ · High-risk Non-muscle Invasive Bladder Cancer	Phase 1/2	Recruiting	RemeGen Co., Ltd.	China
Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens NCT06572319 · ClinicalTrials.gov ↗ · HER2-positive Gastric Cancer, HER2-positive Gastroesophageal Junction Adenocarcinoma	Phase 1/2	Recruiting	Zhejiang Cancer Hospital	China
Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients NCT06650332 · ClinicalTrials.gov ↗ · Metastatic HER2 Positive Gastroesophageal Junction Cancer	Phase 1/2	Recruiting	Zhejiang Cancer Hospital	China
RC48 Monotherapy or Combination With Envafolimab for CDK12 Alterations mCRPC With Standard Treatment Failure NCT06663007 · ClinicalTrials.gov ↗ · Prostate Cancer, CDK12 Gene Mutation	Phase 1/2	Recruiting	Tianjin Medical University Second Hospital	China
RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression NCT05940896 · ClinicalTrials.gov ↗ · Solid Tumor	Phase 1	Recruiting	RemeGen Co., Ltd.	China
RC48-ADC in HER2-low Advanced Breast Cancer NCT05831878 · ClinicalTrials.gov ↗ · Advanced Breast Cancer	Not applicable	Recruiting	RenJi Hospital	China
Bladder-Sparing Treatment With Disitamab Vedotin and Toripalimab With or Without Pelvic Lymph Node Dissection in Bladder Cancer NCT07756008 · ClinicalTrials.gov ↗ · Bladder Urothelial Carcinoma, Muscle-invasive Bladder Cancer, Bladder Cancer	Phase 2/3	Not yet open	Tianjin Medical University Second Hospital	China
RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer NCT06492317 · ClinicalTrials.gov ↗ · HER2-positive Gastric Cancer	Phase 2	Not yet open	The First Affiliated Hospital of Zhengzhou University	China
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 NCT07142200 · ClinicalTrials.gov ↗ · Bladder (Urothelial, Transitional Cell) Cancer	Phase 2	Not yet open	RenJi Hospital	China
Disitamab Vedotin Plus Lenvatinib and PD-1 Inhibitors for Treating HER2-positive Advanced Biliary Tract Cancer NCT07159217 · ClinicalTrials.gov ↗ · Biliary Tract Cancer, Disitamab Vedotin, Lenvatinib	Phase 2	Not yet open	Peking Union Medical College Hospital	China
The Efficacy and Safety RC48 Plus QL1706 in Second-Line Treatment of HER2-Expressing Recurrent CC NCT07172217 · ClinicalTrials.gov ↗ · Recurrent Cervical Cancer	Phase 2	Not yet open	Qilu Hospital of Shandong University	China
Probiotics Combined With Targeted Therapy Plus Immunotherapy in Bladder-Preserving Setting for Patients With MIBC NCT07474064 · ClinicalTrials.gov ↗ · Muscle Invasive Bladder Cancer (MIBC)	Phase 2	Not yet open	chenxu	China
Biomarker-Enriched Kidney-Preserving Strategy With Disitamab Vedotin Plus Tislelizumab in HER2-Positive High-Risk Upper Tract Urothelial Carcinoma NCT07584733 · ClinicalTrials.gov ↗ · Upper Tract Urothelial Carcinoma	Phase 2	Not yet open	RenJi Hospital	China
HERO-UTUC: Intravesical RC48 After RNU for HER2+ UTUC NCT07591805 · ClinicalTrials.gov ↗ · Upper Urinary Tract Urothelial Carcinoma	Phase 2	Not yet open	RenJi Hospital	China
A Single-Arm Study of Sintilimab and Disitamab Vedotin for Locally Advanced Eyelid Sebaceous Gland Carcinoma NCT07740993 · ClinicalTrials.gov ↗ · Sebaceous Gland Carcinoma	Phase 2	Not yet open	West China Hospital	China
Disitamab Vedotin Combined With Ivonescimab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer NCT06957561 · ClinicalTrials.gov ↗ · Bladder Cancer, Muscle-invasive Bladder Cancer	Phase 1/2	Not yet open	Sun Yat-sen University	China
Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis NCT06015113 · ClinicalTrials.gov ↗ · Breast Cancer	Not applicable	Not yet open	Xi'an International Medical Center Hospital	China
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 NCT05911295 · ClinicalTrials.gov ↗ · Urothelial Carcinoma	Phase 3	Active, closed	Seagen, a wholly owned subsidiary of Pfizer	Ireland, UK, USA, China
A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer NCT05980481 · ClinicalTrials.gov ↗ · Gastric Cancer	Phase 2/3	Active, closed	RemeGen Co., Ltd.	China
First-line Treatment with RC48 Plus Tislelizumab and S-1(RCTS) in Advanced Gastric Cancer NCT05586061 · ClinicalTrials.gov ↗ · HER2-positive Gastric Cancer	Phase 2	Active, closed	Qilu Hospital of Shandong University	China
A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2 NCT06003231 · Carcinoma, Non-Small-Cell Lung, Ovarian Neoplasms, Endometrial Neoplasms	Phase 2	Active, closed	Seagen, a wholly owned subsidiary of Pfizer	UK, USA
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors NCT06157892 · ClinicalTrials.gov ↗ · Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms	Phase 2	Active, closed	Seagen, a wholly owned subsidiary of Pfizer	UK, USA
Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer NCT06187506 · ClinicalTrials.gov ↗ · Non-muscle Invasive Bladder Cancer, HER-2 Protein Overexpression	Phase 2	Active, closed	Fudan University	China
A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer NCT06966453 · ClinicalTrials.gov ↗ · Breast Cancer, Breast Neoplasms	Phase 1/2	Active, closed	Pfizer	USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

Conditions studied with Disitamab Vedotin

61 conditions

Breast Cancer5 HER2-positive Gastric Cancer4 Gastric Cancer4 Urothelial Carcinoma3 Gastroesophageal Junction Adenocarcinoma3 Bladder Cancer3 Breast Neoplasms2Scrotum Disease2Bladder Urothelial Carcinoma2Muscle-invasive Bladder Cancer2Advanced Breast Cancer2Upper Urinary Tract Urothelial Carcinoma2

All 61 conditions

Condition (as registered)	Trials
Breast Cancer	5
HER2-positive Gastric Cancer	4
Gastric Cancer	4
Urothelial Carcinoma	3
Gastroesophageal Junction Adenocarcinoma	3
Bladder Cancer	3
Breast Neoplasms	2
Scrotum Disease	2
Bladder Urothelial Carcinoma	2
Muscle-invasive Bladder Cancer	2
Advanced Breast Cancer	2
Upper Urinary Tract Urothelial Carcinoma	2
Carcinoma, Non-Small-Cell Lung	1
Ovarian Neoplasms	1
Endometrial Neoplasms	1
Head and Neck Neoplasms	1
HER2 Low Breast Neoplasms	1
HER2 Positive Breast Neoplasms	1
Paget Disease, Extramammary	1
HER2 + Breast Cancer	1
Non-small Cell Lung Cancer	1
Biliary Tract Cancer	1
Disitamab Vedotin	1
Lenvatinib	1
Immune Checkpoint Inhibitors	1
High-risk Non-muscle Invasive Bladder Cancer	1
HER2-low Breast Cancer	1
Advanced Urothelial Carcinoma	1
Probiotics	1
Immunotherapy	1
Extramammary Paget Disease	1
Metastatic HER2 Positive Gastroesophageal Junction Cancer	1
Neoadjuvant Immunotherapy	1
MIBC	1
HER2-positive Gastroesophageal Junction Adenocarcinoma	1
Gastric Carcinoma	1
Metastatic Breast Cancer	1
Triple Negative Breast Cancer (TNBC)	1
HER2-negative Breast Cancer	1
Muscle Invasive Bladder Cancer (MIBC)	1
Non-Muscle-Invasive Bladder Cancer (NMIBC)	1
Ovarian Cancer Recurrent	1
Lung Cancer	1
Solid Tumor	1
HR Positive/HER2 Low Expression Metastatic Breast Cancer	1
Sebaceous Gland Carcinoma	1
Metastatic Gastric Cancer	1
Unresectable Gastric Carcinoma	1
Non-muscle Invasive Bladder Cancer	1
HER-2 Protein Overexpression	1
Bladder (Urothelial, Transitional Cell) Cancer	1
Upper Tract Urothelial Carcinoma	1
Recurrent Cervical Cancer	1
Ovarian Cancer	1
HER2	1
Prostate Cancer	1
CDK12 Gene Mutation	1
GC/GEJC	1
NMIBC	1
HER2-expressing	1
Advanced Gastroesophageal Adenocarcinoma	1

By country register

Register	Trials	Recruiting
Clinical trials in China	49	34
Clinical trials in USA	5	1
Clinical trials in UK	4	1
Clinical trials in Ireland	1	0

A trial with sites in more than one country appears in each of those registers.

Related compounds

Questions about Disitamab Vedotin trials

How many clinical trials are testing Disitamab Vedotin?

53 current trials in our China, USA, UK and Ireland registers name Disitamab Vedotin (also registered as RC48) as a drug or biological intervention, as of the registry sync on 25 September 2026. Completed and withdrawn studies are not counted.

Are Disitamab Vedotin trials recruiting patients?

Yes. 35 of the 53 trials are recruiting: 34 with sites in China, 1 with sites in USA and 1 with sites in UK. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Disitamab Vedotin clinical trials?

RemeGen Co., Ltd (11), Seagen, a wholly owned subsidiary of Pfizer (4), Fudan University (4) and RenJi Hospital (4), among 24 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Disitamab Vedotin works or whether it is effective, and it is not medical advice.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Disitamab Vedotin works or whether it is effective. Each trial links to its own record so you can check it yourself.

ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Disitamab Vedotin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 25 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.

Disitamab Vedotin clinical trials