Clinical trials: sponsored by RemeGen Co., Ltd.
High-risk Non-muscle Invasive Bladder Cancer
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
The purpose of this study is 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
- Trial name
- NCT06378242
- Testing
- Disitamab Vedotin for injection
- Where
- 6 sites in China
- Volunteers
- 24 people
- Sponsor
- RemeGen Co., Ltd.
Castration-resistant Prostate Cancer
Disitamab Vedotin in the Treatment With HER2- Expression, Subjects With Locally Advanced or Metastatic Castration-resistant Prostate Cancer
The purpose of this study is to evaluate the effectiveness of Disitamab Vedotin in the treatment of subjects with locally advanced or metastatic castration-resistant prostate cancer.
- Trial name
- NCT06227156
- Testing
- Disitamab Vedotin Injection
- Where
- 3 sites in China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer
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
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Toripalimab sequential chemotherapy as in patients with HR-positive, HER2-low breast cancer
- Trial name
- NCT06389006
- Testing
- Disitamab Vedotin for Injection, Toripalimab, Epirubicin
- Where
- China
- Volunteers
- 79 people
- Sponsor
- RemeGen Co., Ltd.
Advanced Solid Tumours
A Study of RC88 Combined With Sintilimab for Advanced Solid Tumours
This study will evaluate safety , clinical pharmacology and efficacy of intravenous RC88 combined with Sintilimab in advancedsolid tumours
- Trial name
- NCT05804526
- Testing
- RC88, Sintilimab Injection
- Where
- China
- Volunteers
- 82 people
- Sponsor
- RemeGen Co., Ltd.
NSCLC
RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC
an open, single-arm, multicenter phase Ib/II study
- Trial name
- NCT05821933
- Testing
- RC108
- Where
- China
- Volunteers
- 106 people
- Sponsor
- RemeGen Co., Ltd.
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction…
- Trial name
- NCT06221748
- Testing
- Disitamab Vedotin Injection, Cadonilimab Injection, Paclitaxel Injection
- Where
- 12 sites in China
- Volunteers
- 90 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer
Neoadjuvant Study of DV in Combination Toripalimab or Sequence Chemotherapy in HR-negative, HER2 Low-expressing Breast Cancer
The purpose of this study is to evaluate the Safety and Efficacy of Neoadjuvant study of DV in combination Toripalimab i or sequence chemotherapy in HR-negative, HER2 low-expressing Breast Cancer
- Trial name
- NCT06227117
- Testing
- Disitamab Vedotin Injection （18 weeks）, Toripalimab （18weeks）, Carboplatin
- Where
- 5 sites in China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
Cervical Cancer
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
This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or…
- Trial name
- NCT06155396
- Testing
- Disitamab Vedotin, Zimberelimab
- Where
- 12 sites in China
- Volunteers
- 116 people
- Sponsor
- RemeGen Co., Ltd.
Breast Neoplasms, Breast Diseases
A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human…
- Conditions
- Breast Neoplasms, Breast Diseases, Capecitabine, HER2-positive Breast Cancer
- Trial name
- NCT03500380
- Testing
- RC48-ADC, Lapatinib, Capecitabine
- Where
- 67 sites in China
- Volunteers
- 301 people
- Sponsor
- RemeGen Co., Ltd.
Melanoma, Stage II, HER2-positive
A Study of RC48-ADC in Advanced Melanoma Subjects With HER2 Variant (Mutation, Amplification, Overexpression)
This is a Phase IIa, single-arm, multicentre, open-label clinical trial aims to evaluate the effectiveness and safety of RC48-ADC in the treatment of HER2 Variant (Mutation, Amplification, Overexpression) advanced melanoma.
- Conditions
- Melanoma, Stage II, HER2-positive, Advanced Melanoma
- Trial name
- NCT05135715
- Testing
- RC48-ADC
- Where
- 4 sites in China
- Volunteers
- 50 people
- Sponsor
- RemeGen Co., Ltd.
Muscle Invasive Bladder Carcinoma
A Study of RC48-ADC Combined With JS001 For Perioperative Treatment of Muscle-Invasive Bladder Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in perioperative treatment of muscle-invasive bladder cancer.
- Trial name
- NCT05297552
- Testing
- RC48-ADC, JS001
- Where
- 3 sites in China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
Gastric Cancer, HER2 Overexpressing Gastric Carcinoma
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression
This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression…
- Trial name
- NCT04714190
- Testing
- RC48-ADC, Paclitaxel injection, Irinotecan Hydrochloride Injection
- Where
- 52 sites in China
- Volunteers
- 351 people
- Sponsor
- RemeGen Co., Ltd.
Biliary Tract Cancer
A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2 overexpressed biliary tract cancer who have failed first-line chemotherapy.
- Trial name
- NCT04329429
- Testing
- RC48-ADC
- Where
- 16 sites in China
- Volunteers
- 57 people
- Sponsor
- RemeGen Co., Ltd.
Non Small Cell Lung Cancer
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
This study will evaluate the efficacy and safety of RC48-ADC for injection in subjects with advanced non-small cell lung cancer with HER2 overexpression or HER2 mutation.
- Trial name
- NCT04311034
- Testing
- RC48
- Where
- China
- Volunteers
- 37 people
- Sponsor
- RemeGen Co., Ltd.
Gastric Cancer
To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG)
This is a single-center, open-label, dose-escalation phase I clinical study.This study aimed to evaluate the safety, tolerability, pharmacokinetics and preliminary clinical efficacy of RC48-ADC combined with RC98 in subjects with…
- Trial name
- NCT05514158
- Testing
- RC48-ADC, RC98
- Where
- China
- Volunteers
- 24 people
- Sponsor
- RemeGen Co., Ltd.
Urothelial Carcinoma, HER2-expressing
A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma
This is a Phase 3, Open-Label, Multicenter, Randomised, Controlled Study designed to compare RC48-ADC in Combination With JS001 to Chemotherapy Alone in Previously Untreated HER2-Expressing Unresectable Locally Advanced or…
- Trial name
- NCT05302284
- Testing
- RC48-ADC, Toripalimab, Gemcitabine
- Where
- 2 sites in China
- Volunteers
- 452 people
- Sponsor
- RemeGen Co., Ltd.
Gynecological Malignancy
A Study of RC48-ADC for the Treatment of HER2-expressing Gynecological Malignancies
This study will evaluate the effectiveness and safety of intravenous injection of RC48-ADC in the treatment of HER2 expression (HER2 positive and HER2 low expression) gynecological malignancies.
- Trial name
- NCT04965519
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
Urothelial Carcinoma
A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2-negative urothelial cancer.
- Trial name
- NCT04073602
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 19 people
- Sponsor
- RemeGen Co., Ltd.
Advanced Breast Cancer
A Study of RC48-ADC in Subjects With Advanced Breast Cancer
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection in subjects with advanced breast cancer with HER2 positive or HER2 low expression
- Trial name
- NCT03052634
- Testing
- RC48-ADC 1.5 mg/kg (HER2 Positive), RC48-ADC 2.0 mg/kg (HER2 Positive), RC48-ADC 2.5 mg/kg (HER2 Positive)
- Where
- 7 sites in China
- Volunteers
- 112 people
- Sponsor
- RemeGen Co., Ltd.
Diabetic Macular Edema
Evaluation of RC28-E Injection in Diabetic Macular Edema
This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with diabetic macular edema.
- Trial name
- NCT04782115
- Testing
- intravitreal injection of RC28-E, Conbercept
- Where
- 37 sites in China
- Volunteers
- 156 people
- Sponsor
- RemeGen Co., Ltd.