Clinical trials: sponsored by 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.
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.
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.
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.
NMIBC
RC48-ADC in Combination With Gemcitabine in High Risk NMIBC Subjects
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in…
- Trial name
- NCT05943379
- Testing
- RC48-ADC in Combination with gemcitabine
- Where
- China
- Volunteers
- 85 people
- Sponsor
- RemeGen Co., Ltd.
Unresectable Solid Tumor, Metastatic Solid Tumor
A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours
This is a Phase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in Patients with Locally Advanced Unresectable/Metastatic Solid Tumours to determine the safety and tolerability of RC118, including the…
- Conditions
- Unresectable Solid Tumor, Metastatic Solid Tumor, Locally Advanced Solid Tumor
- Trial name
- NCT04914117
- Testing
- RC118 for injection
- Where
- 4 sites in Australia
- Volunteers
- 7 people
- Sponsor
- RemeGen Co., Ltd.
Systemic Lupus Erythematosus
Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE.
- Trial name
- NCT04082416
- Testing
- RC18 160 mg plus standard therapy
- Where
- China
- Volunteers
- 335 people
- Sponsor
- RemeGen Co., Ltd.
Gastric Cancer, HER2 Overexpressing Gastric Carcinoma
A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer Subjects With the Overexpression of HER2
This study will evaluate the efficacy and safety of intravenous RC48-ADC in local advanced or metastatic gastric patients with the overexpression of HER2.
- Trial name
- NCT03556345
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 127 people
- Sponsor
- RemeGen Co., Ltd.
Wet Age-Related Macular Degeneration
Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration
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 wet age-related macular degeneration by multiple…
- Trial name
- NCT04270669
- Testing
- intravitreal injection of RC28-E 0.5mg, intravitreal injection of RC28-E 1.0mg, intravitreal injection of RC28-E2.0mg
- Where
- China
- Volunteers
- 37 people
- Sponsor
- RemeGen Co., Ltd.
Neovascular Age-related Macular Degeneration
Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration
The purpose of this first-in-human study is to evaluate the safety, tolerability and pharmacokinetics of single intravitreous injections,single ascending doses, of RC28-E(a chimeric decoy receptor trap fusion protein by dual…
- Trial name
- NCT03777254
- Testing
- RC28-E
- Where
- China
- Volunteers
- 12 people
- Sponsor
- RemeGen Co., Ltd.
Solid Tumors
A Study of RC48-ADC in Subjects With HER2-Positive Advanced Malignant Solid Tumors
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
- Trial name
- NCT02881138
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 24 people
- Sponsor
- RemeGen Co., Ltd.
Solid Tumors
Study of RC48-ADC Administered Intravenously to Subjects With HER2-Positive in Advanced Malignant Solid Tumors
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.
- Trial name
- NCT02881190
- Testing
- RC48-ADC
- Where
- China
- Volunteers
- 57 people
- Sponsor
- RemeGen Co., Ltd.
Systemic Lupus Erythematosus
Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
The purpose of this study is to initially access the safety and effectivity of RC18 combined with standard treatment and Placebo combined with standard therapy in subjects with Moderate to severe SLE, Besides ,to provide dose…
- Trial name
- NCT02885610
- Testing
- RC18 80 mg plus standard therapy, RC18 160 mg plus standard therapy, RC18 240 mg plus standard therapy
- Where
- China
- Volunteers
- 249 people
- Sponsor
- RemeGen Co., Ltd.
Healthy
A Phase I Study of TACI-antibody Fusion Protein Injection (RC18) in Healthy Adult Chinese Subjects
to evaluate the pharmacokinetics, and pharmacodynamics of a single dose of Tai Ai injection in healthy adult Chinese subjects
- Trial name
- NCT04235933
- Testing
- Tai Ai(RC18) 80mg, Tai Ai(RC18) 160mg, RC18 240mg
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- RemeGen Co., Ltd.
Urothelial Carcinoma, Advanced Cancer
A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with local advanced or metastatic HER2 positive endothelial cancer.
- Trial name
- NCT03507166
- Testing
- RC48-ADC
- Where
- 2 sites in China
- Volunteers
- 43 people
- Sponsor
- RemeGen Co., Ltd.