Clinical trials: sponsored by 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.
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.
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.
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.
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.
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.
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.
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.
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.
The purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable…
- Trial name
- NCT06155383
- Testing
- Capecitabine, oxaliplatin, Disitamab Vedotin
- Where
- 11 sites in China
- Volunteers
- 90 people
- Sponsor
- RemeGen Co., Ltd.
IgA Nephropathy
A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA…
- Trial name
- NCT04905212
- Testing
- Telitacicept 160mg, Telitacicept 240mg
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- RemeGen Co., Ltd.
Systemic Lupus Erythematosus
Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus
This is a multi-center, open-label, phase I study.
- Trial name
- NCT05247203
- Testing
- Telitacicept, standard therapy
- Where
- 19 sites in China
- Volunteers
- 92 people
- Sponsor
- RemeGen Co., Ltd.
Urothelial Carcinoma
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
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with HER2 overexpressing locally advanced or metastatic urothelial cancer.
- Trial name
- NCT03809013
- Testing
- RC48-ADC
- Where
- 8 sites in China
- Volunteers
- 64 people
- Sponsor
- RemeGen Co., Ltd.
Solid Tumors
A Study of RC98 in Subjects With Advanced Malignant Solid Tumors
This study will evaluate the safety, tolerability and pharmacokinetics of RC98 for injeciton in subjects with advanced malignant solid tumors.
- Trial name
- NCT04190823
- Testing
- RC98
- Where
- China
- Volunteers
- 63 people
- Sponsor
- RemeGen Co., Ltd.
Solid Tumor
RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression
To evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of Disitamab Vedotin(DV, RC48-ADC) intravenously combined with radiotherapy in the treatment of locally advanced solid tumors with…
- Trial name
- NCT05940896
- Testing
- Disitamab vedotin
- Where
- China
- Volunteers
- 24 people
- Sponsor
- RemeGen Co., Ltd.
Diabetic Retinopathy
Evaluation of RC28-E Injection in Diabetic Retinopathy
This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately…
- Trial name
- NCT04782128
- Testing
- RC28-E injection
- Where
- China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
Diabetic Macular Edema
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.
- Trial name
- NCT05885503
- Testing
- RC-28E, Aflibercept
- Where
- China
- Volunteers
- 316 people
- Sponsor
- RemeGen Co., Ltd.
Wet Age-related Macular Degeneration
Efficacy and Safety of RC28-E Versus Aflibercept
This is a randomized, double-masked, multicenter study comparing the the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) versus aflibercept in patients…
- Trial name
- NCT05727397
- Testing
- RC28-E, Aflibercept
- Where
- China
- Volunteers
- 432 people
- Sponsor
- RemeGen Co., Ltd.
Non-Muscle Invasive Bladder Cancer, HER2
RC48 Combined With Tislelizumab for Bladder Sparing Treatment in NMIBC With BCG Treatment Failure and HER2 Expression
This is a prospective, open, single-center clinical study of anti-HER2-ADC combined with PD-1 monoclonal antibody for bladder sparing treatment in non-muscular invasive bladder cancer (NMIBC) patients with HER2-expressing.
- Trial name
- NCT05957757
- Testing
- RC48, Tislelizumab
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- RenJi Hospital
HER2-Positive Solid Tumors
JS001 in Combination With RC48-ADC in Treatment of HER2-Positive Advanced Malignant Solid Tumors
This is a non-randomized, open-label, single-arm, multicenter Phase I clinical trial which will evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of RC48-ADC in combinaton with Anti-PD1 Monoclonal Antibody in…
- Trial name
- NCT04280341
- Testing
- RC48-ADC in combinaton with JS001
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking University
Non-muscle Invasive Bladder Cancer
RC48-ADC in Adjuvant/Salvage Treatment of HER2 Positive Non-muscle-invasive Bladder Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC in adjuvant/salvage treatment of HER2 positive high-risk non-muscle-invasive bladder cancer.
- Trial name
- NCT05996952
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 77 people
- Sponsor
- West China Hospital