Clinical trials: sponsored by Lepu Biopharma Co., Ltd.
Squamous Cell Carcinoma of Head and Neck (SCCHN)
Becotatug Vedotin Plus Pucotenlimab in Locally Advanced Head and Neck Squamous Cell Carcinoma With Suboptimal Response to Induction Immunochemotherapy
Patients with locally advanced head and neck squamous cell carcinoma (HNSCC) may receive chemotherapy combined with immunotherapy before surgery to reduce tumor size.
- Trial name
- NCT07915258
- Testing
- Becotatug Vedotin (MRG003), Pucotenlimab
- Where
- 4 sites in China
- Volunteers
- 22 people
- Sponsor
- Sun Yat-sen University
Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 and the combination of MRG003 and HX008 in patients with recurrent or metastatic squamous cell carcinoma of head and…
- Trial name
- NCT04868162
- Testing
- MRG003, MRG003+HX008
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Advanced or Metastatic Gastric Cancer, Advanced or Metastatic Gastroesophageal Junction Carcinoma
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Advanced Gastric Cancer.
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with EGFR-positive, HER2-negative, inoperable locally advanced or metastatic gastric cancer.
- Trial name
- NCT05188209
- Testing
- MRG003
- Where
- 5 sites in China
- Volunteers
- 6 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Advanced or Metastatic Biliary Tract Cancer
A Study of MRG003 in the Treatment of EGFR-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 as single agent in EGFR-positive unresectable locally advanced or metastatic biliary tract cancer patients who have…
- Trial name
- NCT04838964
- Testing
- MRG003
- Where
- 7 sites in China
- Volunteers
- 15 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Carcinoma, Non-Small-Cell Lung
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With EGFR-Positive Advanced Non-Small Cell Lung Cancer
The objective of this study is to assess the efficacy, safety of MRG003 as single agent in EGFR-positive advanced non-small cell lung cancer
- Trial name
- NCT04838548
- Testing
- MRG003
- Where
- China
- Volunteers
- 87 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Advanced Solid Tumors
A Study of MRG003 in the Treatment of Patients With EGFR-positive Advanced or Metastatic Solid Tumors
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in combination with HX008 in patients with EGFR-positive advanced or metastatic solid tumors.
- Trial name
- NCT05688605
- Testing
- MRG003+HX008
- Where
- 2 sites in China
- Volunteers
- 18 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Squamous Cell Carcinoma of the Head and Neck
A Study to Evaluate MRG003 vs Cetuximab/Methotrexate in in the Treatment of Patients With RM-SCCHN
The objective of this study is to compare the efficacy and safety of MRG003 versus cetuximab/methotrexate as second/third line of therapy in patients with RM-SCCHN who have previously failed PD-1 (L1) inhibitors and…
- Trial name
- NCT05751512
- Testing
- MRG003, Cetuximab injection, Methotrexate Injection
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Recurrent or Metastatic Nasopharyngeal Carcinoma
A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
This is a randomized, open-label, multi-center, phase III study to evaluate the efficacy and safety, and immunogenicity of MRG003 in combination with pucotenlimab in patients with recurrent or metastatic nasopharyngeal carcinoma.
- Trial name
- Magic-C002 (NCT06976190)
- Testing
- MRG003 + Pucotenlimab, Gemcitabine, Docetaxel, or Capecitabine
- Where
- China
- Volunteers
- 446 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Recurrent or Metastatic Nasopharyngeal Carcinoma
A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma
The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG003 in patients with recurrent metastatic nasopharyngeal carcinoma.
- Trial name
- NCT05126719
- Testing
- MRG003, Capecitabine tablets, Docetaxel injection
- Where
- 23 sites in China
- Volunteers
- 238 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Advanced Solid Tumors
A Study of MRG003 in Patients With Advanced Solid Tumors
The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG003, as well as immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG003 in patients with advanced solid tumors…
- Trial name
- NCT04868344
- Testing
- MRG003
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Oral Squamous Cell Carcinoma, Head and Neck Cancer
Neoadjuvant Presurgical Becotatug Vedotin (MRG003) Plus Pucotenlimab (HX008) in Oral Cavity Squamous Cell Carcinoma
This is a phase 2, open-label, single-arm clinical trial evaluating neoadjuvant therapy with Becotatug vedotin (MRG003) combined with Pucotenlimab (HX008) in patients with previously untreated, resectable stage III-IVA oral…
- Conditions
- Oral Squamous Cell Carcinoma, Head and Neck Cancer, Locally Advanced Head and Neck Cancer, Neoadjuvant Therapy
- Trial name
- NCT07766889
- Testing
- Becotatug Vedotin (MRG003), Pucotenlimab
- Where
- 2 sites in China
- Volunteers
- 32 people
- Sponsor
- Sun Yat-sen University
Locally Advanced or Metastatic Solid Tumors, Colorectal Cancer
A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
This is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.
- Conditions
- Locally Advanced or Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer
- Trial name
- NCT07066657
- Testing
- MRG007, MRG007 and Bevacizumab
- Where
- 21 sites in United States, China
- Volunteers
- 572 people
- Sponsor
- ArriVent BioPharma, Inc.
Advanced Colorectal Cancer
A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer
This is a Phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of MRG007 combination therapy in patients with advanced colorectal cancer.
- Trial name
- NCT07737600
- Testing
- MRG007, 5-Fluorouracil / Leucovorin Calcium, Bevacizumab
- Where
- China
- Volunteers
- 316 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Hepatocellular Carcinoma
MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II)
This is an open-label, multicenter, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of MRG006A in combination with immune checkpoint inhibitors and targeted…
- Trial name
- NCT07479485
- Testing
- MRG006A, Pucotenlimab, Bevacizumab
- Where
- 8 sites in China
- Volunteers
- 160 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Advanced Refractory Solid Tumors, EGFR Gene Overexpression
Phase II Study of Becotatug Vedotin Plus Pucotenlimab for Advanced Refractory Solid Tumors With EGFR-Positive
This phase II trial evaluates the combination of Becotatug Vedotin (MRG003), an EGFR-targeting ADC, and Pucotenlimab (HX008), a PD-1 inhibitor, in patients with high EGFR expressing advanced refractory solid tumors.
- Trial name
- NCT07712029
- Testing
- Becotatug Vedotin, Pucotenlimab
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Tianjin Medical University Second Hospital
Head and Neck Squamous Cell Carcinoma
Pucotenlimab Plus Becotatug Vedotin in Perioperative Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma
A multicenter, randomized, double-blind, phase II clinical study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of Becotatug Vedotin for Injection in combination with PD-1 in patients with locally…
- Trial name
- NCT07586124
- Testing
- Becotatug Vedotin for Injection, Pucotenlimab Injection
- Where
- 15 sites in China
- Volunteers
- 80 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Advanced or Metastatic Solid Tumors
A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors
The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic solid tumors.
- Trial name
- NCT04843709
- Testing
- MRG004A
- Where
- 9 sites in United States, China
- Volunteers
- 39 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Advanced Pancreatic Cancer
A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer
This is a randomized, double-blind, multi-center, phase III study to evaluate the efficacy and safety, pharmacokinetic profile and immunogenicity of MRG004A in patients with advanced pancreatic cancer.
- Trial name
- NCT07138846
- Testing
- MRG004A plus best supportive care
- Where
- China
- Volunteers
- 231 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer
Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin
This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.
- Trial name
- NCT07283835
- Testing
- Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside
- Where
- 14 sites in China
- Volunteers
- 16 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Cutaneous Squamous Cell Carcinoma (CSCC)
Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma
Study Design The study plans to enroll 38 patients. A Simon's two-stage design is employed. Based on historical data, the objective response rate (ORR) for patients meeting the inclusion criteria and receiving PD-1 inhibitor…
- Trial name
- NCT07394244
- Testing
- Pucotenlimab, Becotatug Vedotin
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Fudan University