Clinical trials: sponsored by RemeGen Co., Ltd.
Digestive Cancer
A Study of RC108-ADC in Subjects With Advanced Digestive System Malignant Tumor
A multi-center, open-label, study designed to evaluate the preliminary efficacy, safety and pharmacokinetics of RC108 in patients with c-Me-positive advanced digestive system malignancies.
- Trial name
- NCT05628857
- Testing
- RC108
- Where
- China
- Volunteers
- 29 people
- Sponsor
- RemeGen Co., Ltd.
Advanced Solid Tumours
A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours
The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies
- Trial name
- NCT05508334
- Testing
- RC88
- Where
- 2 sites in China
- Volunteers
- 41 people
- Sponsor
- RemeGen Co., Ltd.
Primary IgA Nephropathy
A Study of Telitacicept for IgA Nephropathy (TELIGAN)
The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal disease(ESRD), despite maximum tolerated treatment with…
- Trial name
- NCT05799287
- Testing
- Telitacicept
- Where
- 101 sites in China
- Volunteers
- 318 people
- Sponsor
- RemeGen Co., Ltd.
Solid Tumors
A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors
The primary objective is to evaluate the safety and tolerability of RC278; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC278; and determine the recommended phase 2 dose (RP2D)， and assess…
- Trial name
- NCT07105215
- Testing
- RC278
- Where
- 39 sites in China
- Volunteers
- 312 people
- Sponsor
- RemeGen Co., Ltd.
Primary Sjogren's Syndrome
A Study to Evaluate the Efficacy and Safety of Telitacicept in Subjects With Active Primary Sjogren's Syndrome
The purpose of this study is to evaluate the efficacy and safety of subcutaneous Telitacicept versus placebo in subjects with active primary Sjogren's Syndrome.
- Trial name
- NCT05673993
- Testing
- Telitacicept 80 mg, Telitacicept 160 mg
- Where
- 78 sites in China
- Volunteers
- 381 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer
DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin in combination with Pertuzumab with or without Toripalimab neoadjuvant therapy in patients with HER2-positive breast cancer.
- Trial name
- NCT06178159
- Testing
- Disitamab Vedotin Injection, Pertuzumab Injection, Toripalimab
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
Gastric Cancer
A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
This is a Phase II/III, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of RC48-ADC combine with Toripalimab and chemotherapy or RC48-ADC combine with Toripalimab and Trastuzumab as…
- Trial name
- NCT05980481
- Testing
- RC48-ADC（2.5mg/kg）, Trastuzumab, Toripalimab
- Where
- China
- Volunteers
- 201 people
- Sponsor
- RemeGen Co., Ltd.
Non-Small Cell Lung Cancer
A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC
- Trial name
- NCT06962865
- Testing
- RC108, Furmonertinib Mesilate Tablets Monotherapy
- Where
- 34 sites in China
- Volunteers
- 80 people
- Sponsor
- RemeGen Co., Ltd.
Myasthenia Gravis, Generalized
Study of Telitacicept in Generalized Myasthenia Gravis
The purpose of this study is to evaluate the efficacy and safety of Telitacicept in the treatment of patients with generalized myasthenia gravis.
- Trial name
- NCT05737160
- Testing
- Telitacicept
- Where
- 51 sites in China
- Volunteers
- 114 people
- Sponsor
- RemeGen Co., Ltd.
Gastric Carcinoma
A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin combined with Tislelizumab and CAPOX versus Tislelizumab combined with CAPOX as first-line treatment for patients with HER2-low advanced…
- Trial name
- NCT06944496
- Testing
- Disitamab Vedotin+Tislelizumab+Oxaliplatin+Capecitabine, Tislelizumab+Oxaliplatin+Capecitabine
- Where
- China
- Volunteers
- 616 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally…
- Trial name
- NCT06642545
- Testing
- Disitamab Vedotin, RC148, Albumin-bound Paclitaxone
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
Advanced Solid Tumor
A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors
This is an open, multi-center, dose escalation and expansion phase I/II study. The Phase I study will explore the tolerability and safety of RC118 in combination with Toripalimab for the treatment of patients with Claudin…
- Trial name
- NCT06038396
- Testing
- RC118, Toripalimab, RC148
- Where
- 18 sites in China
- Volunteers
- 48 people
- Sponsor
- RemeGen Co., Ltd.
Advanced Solid Tumor
A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
In Phase I, This study will explore the tolerability and safety of RC118 in patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression, and determine the maximum…
- Trial name
- NCT05205850
- Testing
- RC118-ADC
- Where
- 2 sites in China
- Volunteers
- 135 people
- Sponsor
- RemeGen Co., Ltd.
Solid Tumor
A Study of RC148 As a Single Agent and Combination Therapy in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid…
- Trial name
- NCT06016062
- Testing
- RC148 Monotherapy, RC148+docetaxel Combination Therapy, RC148+RC48 Combination Therapy
- Where
- 31 sites in China
- Volunteers
- 221 people
- Sponsor
- RemeGen Co., Ltd.
Moderate and Severe RheumatoId Arthritis
A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects with Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.
The purpose of this study is to initially access the safety and effectivity of RC18 combined with methotrexate (MTX) in comparison with the use of methotrexate alone in participants with moderate to severe Rheumatoid Arthritis…
- Trial name
- NCT03016013
- Testing
- RC18 160 mg plus MTX
- Where
- China
- Volunteers
- 479 people
- Sponsor
- RemeGen Co., Ltd.
Lupus Nephritis
A Study of Telitacicept in Lupus Nephritis
The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.
- Trial name
- NCT05680480
- Testing
- Telitacicept 240 mg, Telitacicept 160 mg
- Where
- 45 sites in China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
Primary IgA Nephropathy
A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy
To evaluate the safety and efficacy of Tai Ai(Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection) in the treatment of IgA nephropathy.
- Trial name
- NCT04291781
- Testing
- RC18 160mg, RC18 240mg
- Where
- China
- Volunteers
- 44 people
- Sponsor
- RemeGen Co., Ltd.
Breast Neoplasms
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast…
- Trial name
- NCT06105008
- Testing
- Disitamab Vedotin, Toripalimab
- Where
- 3 sites in China
- Sponsor
- RemeGen Co., Ltd.
Melanoma, Urothelial Carcinoma
A RC198 Study in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors
Safety study of RC198 in Subjects with Solid Tumors.
- Conditions
- Melanoma, Urothelial Carcinoma, Renal Cell Carcinoma, Non-small Cell Lung Cancer
- Trial name
- NCT05867303
- Testing
- RC198 Injection
- Where
- 5 sites in Australia, China
- Volunteers
- 48 people
- Sponsor
- RemeGen Co., Ltd.
Healthy
A Single Dose Study to Investigate the Pharmacokinetics (PK) of Telitacicept Pre-filled Injection and Freeze-dried Powder Injection in Chinese Healthy Subjects
This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to evaluate the Pharmacokinetics and safety of Telitacicept Pre-filled Injection and Freeze-dried…
- Trial name
- NCT06549959
- Testing
- Telitacicept Pre-filled Injection 80mg, Telitacicept Freeze-dried powder Injection 80mg
- Where
- 3 sites in China
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- RemeGen Co., Ltd.