Clinical trials: sponsored by RemeGen Co., Ltd.
Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line Therapy
Phase II Clinical Study of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer
RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer
- Trial name
- NCT07895355
- Testing
- RC148 plus Telisotuzumab adizutecan, Telisotuzumab adizutecan plus Bevacizumab
- Where
- China
- Volunteers
- 412 people
- Sponsor
- RemeGen Co., Ltd.
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148 as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
To Evaluate the Safety, Tolerability, and Preliminary Antitumor Efficacy of RC148 in Combination with Telisotuzumab adizutecan as First-line Treatment for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer
- Trial name
- NCT07874282
- Testing
- Telisotuzumab adizutecan plus RC148
- Where
- China
- Volunteers
- 200 people
- Sponsor
- RemeGen Co., Ltd.
Upper Tract Urothelial Carcinoma
Disitamab Vedotin Plus Radiotherapy for Adjuvant Treatment of HER2-Expressing Cisplatin-Ineligible Upper Tract Urothelial Carcinoma
This randomized, open-label, multicenter phase III study is designed to compare disitamab vedotin plus radiotherapy with gemcitabine plus carboplatin as adjuvant treatment in patients with HER2-expressing upper tract urothelial…
- Trial name
- LUXUS41 (NCT07498907)
- Testing
- Disitamab Vedotin (RC48), radiotherapy, Gemcitabine (1000 mg/m2)
- Where
- China
- Volunteers
- 192 people
- Sponsor
- Peking University First Hospital
Breast Cancer
A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2
This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens…
- Trial name
- NCT04400695
- Testing
- RC48-ADC, Paclitaxel Injection, Docetaxel Injection
- Where
- China
- Volunteers
- 366 people
- Sponsor
- RemeGen Co., Ltd.
Solid Tumors
A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC288 in the Treatment of Solid Tumors
The primary objective is to evaluate the safety and tolerability of RC288; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC288; and determine the recommended phase 2 dose (RP2D), and assess…
- Trial name
- NCT07537881
- Testing
- RC288 For Injection
- Where
- 14 sites in China
- Volunteers
- 326 people
- Sponsor
- RemeGen Co., Ltd.
Non-small Cell Lung Cancer
A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.
- Trial name
- NCT05745740
- Testing
- RC48-ADC, Pyrotinib
- Where
- China
- Volunteers
- 26 people
- Sponsor
- RemeGen Co., Ltd.
Previously Untreated Locally Advanced (IIIB/IIIC) or Metastatic (IV) e Nsq NSCLC Without Actionable Genomic Alterations
Phase III Study of RC148 Plus Chemotherapy Versus Tislelizumab Plus Chemotherapy as First-Line Treatment for Non-Squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations
To evaluate the efficacy and safety of RC148 plus platinum-based chemotherapy versus tislelizumab plus platinum-based chemotherapy in trial participants with previously untreated locally advanced (Stage IIIB/IIIC) or metastatic…
- Trial name
- NCT07829549
- Testing
- RC148 Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection, Tislelizumab Injection plus Pemetrexed Disodium for Injection and Carboplatin Injection
- Where
- China
- Volunteers
- 540 people
- Sponsor
- RemeGen Co., Ltd.
Gastric Carcinoma
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.
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Trastuzumab and Tislelizumab Versus Chemotherapy Combined with Trastuzumab with or without Pembrolizumab as First-Line Treatment…
- Trial name
- NCT07315750
- Testing
- Disitamab Vedotin, Tislelizumab, CAPOX (oxaliplatin/capecitabine)
- Where
- China
- Volunteers
- 555 people
- Sponsor
- RemeGen Co., Ltd.
Urothelial Carcinoma
Disitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2
This study will enroll participants with urothelial cancer (UC). UC can include cancer of the bladder, kidney, or the tubes that carry pee through the body (ureter, urethra).
- Trial name
- NCT05911295
- Testing
- disitamab vedotin, pembrolizumab, gemcitabine
- Where
- 268 sites in United States, Argentina and 22 more
- Volunteers
- 412 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood.
- Conditions
- Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms
- Trial name
- NCT06157892
- Testing
- disitamab vedotin, tucatinib
- Where
- 135 sites in United States, Australia and 8 more
- Volunteers
- 54 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Non-Small Cell Lung Cancer
RC148 Plus Platinum-Based Chemotherapy vs Tislelizumab Plus Platinum-Based Chemotherapy for First-Line Squamous Non-Small Cell Lung Cancer (sqNSCLC)
This study aims to evaluate the efficacy and safety of RC148 combined with platinum-based chemotherapy versus Tislelizumab combined with platinum-based chemotherapy in participants with locally advanced or metastatic Squamous…
- Trial name
- NCT07416474
- Testing
- RC148 plus Carboplatin and Paclitaxel, Tislelizumab plus Carboplatin and Paclitaxel
- Where
- 78 sites in China
- Volunteers
- 574 people
- Sponsor
- RemeGen Co., Ltd.
Systemic Myasthenia Gravis
A Study of TACI（Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor）-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with systemic myasthenia gravis.
- Trial name
- NCT04302103
- Testing
- RC18 160mg, RC18 240 mg
- Where
- 24 sites in China
- Volunteers
- 29 people
- Sponsor
- RemeGen Co., Ltd.
Primary Sjögren's Syndrome
A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.
- Trial name
- NCT04078386
- Testing
- RC18 240 mg, RC18 160 mg
- Where
- 14 sites in China
- Volunteers
- 42 people
- Sponsor
- RemeGen Co., Ltd.
Colorectal (Colon or Rectal) Cancer
A Phase Ⅱ/Ⅲ Clinical Trial of RC148 Plus Chemotherapy as 1L Therapy for Unresectable or Metastatic Colorectal Cancer
This is a Phase Ⅱ/Ⅲ study. The purpose of this study is to evaluate the efficacy and safety of RC148 combined with chemotherapy for the first-line treatment of unresectable metastatic colorectal cancer (CRC)
- Trial name
- NCT07462143
- Testing
- RC148 (Dose 1) plus Capecitabine and Oxaliplatin, RC148 (Dose 2) plus Capecitabine and Oxaliplatin
- Where
- 19 sites in China
- Volunteers
- 80 people
- Sponsor
- RemeGen Co., Ltd.
Neuromyelitis Optica Spectrum Disorders
A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Neuromyelitis Optica Spectrum Disorders.
- Trial name
- NCT03330418
- Testing
- RC18 160 mg
- Where
- China
- Volunteers
- 178 people
- Sponsor
- RemeGen Co., Ltd.
Multiple Sclerosis, Relapsing-Remitting
RC18 in Patients With Relapsing Remitting Multiple Sclerosis：a Phase II Trial
To observe the safety and effectivity of a Recombinant Human B Lymphocyte Stimulator Receptor : Immunoglobulin G( IgG ) Fc Fusion Protein for injection (RC18) in patients with relapsing remitting multiple sclerosis, analyze the…
- Trial name
- NCT04625153
- Testing
- RC18 160mg, RC18 240mg
- Where
- China
- Volunteers
- 8 people
- Sponsor
- RemeGen Co., Ltd.
CTD-ILD
Phase III Clinical Trial of Telitacicept Injection in the Treatment of Patients With Connective Tissue Disease-related Interstitial Lung Disease
Interstitial lung disease (ILD) is a common pulmonary manifestation in chronic tissue diseases (CTD), significantly affecting patient's prognosis.
- Trial name
- NCT07495033
- Testing
- Telitacicept
- Where
- China
- Volunteers
- 260 people
- Sponsor
- RemeGen Co., Ltd.
Myasthenia Gravis, Ocular
A Study of Telitacicept in Patients With Ocular Myasthenia Gravis (OMG)
This is a Phase III, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Telitacicept for the treatment of Ocular Myasthenia Gravis (OMG).Approximately 120 eligible…
- Trial name
- NCT07249632
- Testing
- Telitacicept
- Where
- China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
Gastric Adenocarcinoma
A Study of Disitamab Vedotin, Tunlametinib, and PD-1 Antibody for Advanced Gastric Cancer
The goal of this clinical trial is to learn if the combination of disitamab vedotin, tunlametinib, and a PD-1 antibody works to treat HER2-overexpressing advanced gastric cancer in patients who have already received at least two…
- Trial name
- DTP-HER2 (NCT07507526)
- Testing
- Tunlametinib+PD-1 mAb
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Sun Yat-sen University
Systemic Lupus Erythematosus
A Study of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus
This is a multi-center, open-label, phase 1 study.
- Trial name
- NCT05687526
- Testing
- Telitacicept
- Where
- 12 sites in China
- Volunteers
- 16 people
- Sponsor
- RemeGen Co., Ltd.