Clinical trials: sponsored by Shanghai Henlius Biotech
Health Adult Subjects
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®
The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent…
- Trial name
- NCT07495930
- Testing
- HLX319, EU-Phesgo
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Breast Cancer (Triple Negative Breast Cancer (TNBC))
Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with…
- Trial name
- NCT07487519
- Testing
- HLX43 DOSE 1 IN ≥2L TNBC, HLX43 DOSE 2 IN ≥2L TNBC, HLX43 DOSE 1 + HLX10
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Shanghai Henlius Biotech
HER2 + Breast Cancer
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer
- Trial name
- NCT07294508
- Testing
- HLX87 + HLX22, HLX87 + Pertuzumab, T-Dxd + Pertuzumab
- Where
- China
- Volunteers
- 706 people
- Sponsor
- Shanghai Henlius Biotech
Healthy Adult Male
A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects
The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.
- Trial name
- NCT07484893
- Testing
- recombinant human hyaluronidase
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Advanced/Metastatic Solid Tumors
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX97 (a KAT6A/B Inhibitor) in Patients With Advanced/Metastatic Solid Tumor
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profiles, and preliminary efficacy of HLX97 ( KAT6A/B inhibitor) in patients with advanced/metastatic solid…
- Trial name
- NCT07480681
- Testing
- HLX97, Fulvestrant
- Volunteers
- 138 people
- Sponsor
- Shanghai Henlius Biotech
Hepatocellular Carcinoma (HCC)
Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma
This is a multicenter, randomized, double-blind, parallel-controlled, phase I clinical study to evaluate the PK characteristics, safety, efficacy, and immunogenicity of HLX13 and US-sourced YERVOY® in patients with unresectable…
- Trial name
- NCT07176650
- Testing
- HLX13, Yervoy, OPDIVO
- Where
- 51 sites in United States, China
- Volunteers
- 246 people
- Sponsor
- Shanghai Henlius Biotech
Hormone Receptor Positive HER-2 Negative Breast Cancer
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care.
- Trial name
- NCT07459738
- Testing
- HLX43
- Volunteers
- 60 people
- Sponsor
- Shanghai Henlius Biotech
Carcinoma of Head and/or Neck
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
- Trial name
- NCT06857279
- Testing
- HLX43 DOSE 1, HLX43 DOSE 2, HLX43 DOSE 3
- Where
- 2 sites in China
- Volunteers
- 167 people
- Sponsor
- Shanghai Henlius Biotech
Advanced/Metastatic Solid Tumors, NSCLC
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX37 in Advanced/Metastatic Solid Tumors
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX37 in patients with advanced/metastatic solid tumors.
- Trial name
- NCT07274813
- Testing
- HLX37
- Where
- 2 sites in China
- Volunteers
- 254 people
- Sponsor
- Shanghai Henlius Biotech
Gastroesophageal-junction Cancer, Monoclonal Antibody
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with…
- Conditions
- Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT06532006
- Testing
- HLX22, Pembrolizumab, Trastuzumab
- Where
- 208 sites in United States, Argentina and 15 more
- Volunteers
- 550 people
- Sponsor
- Shanghai Henlius Biotech
Colon Cancer Adenocarcinoma
A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer
This study is a phase Ib/II study to evaluate the efficacy, safety and tolerance of HLX43 combined with HLX07 or Serplulimab in patients with advanced or metastatic colorectal cancer failed or intolerance to standard first-line…
- Trial name
- NCT07358585
- Testing
- HLX43 dose 1 + HLX07, HLX43 dose 2 + HLX07, HLX43 dose 3 + Serplulimab
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Shanghai Henlius Biotech
Limited-Stage Small Cell Lung Cancer
A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in…
- Trial name
- NCT05353257
- Testing
- HLX10, carboplatin/cisplatin-etoposide, Thoracic radiotherapy
- Where
- 129 sites in United States, Austria and 9 more
- Volunteers
- 511 people
- Sponsor
- Shanghai Henlius Biotech
Squamous NSCLC
A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer
The study consists of two parts: Part I is a randomized, double-blind, multicenter, parallel-controlled phase II clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus…
- Trial name
- NCT07318883
- Testing
- HLX07, Serplulimab, Pembrolizumab
- Where
- China
- Volunteers
- 720 people
- Sponsor
- Shanghai Henlius Biotech
Pancreatic Ductal Adenocarcinoma (PDAC)
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Pancreatic Cancer
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Pancreatic ductal adenocarcinoma (PDAC)
- Trial name
- NCT07301229
- Testing
- HLX43 DOSE 1 (2.5 mg/kg), HLX43 DOSE 2 (3.0 mg/kg)
- Volunteers
- 100 people
- Sponsor
- Shanghai Henlius Biotech
HER2 + Breast Cancer
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer
The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.
- Trial name
- NCT07294534
- Testing
- HLX87+HX22, HLX87 + Pertuzumab, TCbHP
- Volunteers
- 817 people
- Sponsor
- Shanghai Henlius Biotech
Extensive Stage Small Cell Lung Cancer
A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell…
- Trial name
- NCT04063163
- Testing
- HLX10, carboplatin and etoposide
- Where
- 5 sites in Georgia, Poland and 3 more
- Volunteers
- 585 people
- Sponsor
- Shanghai Henlius Biotech
Nasopharyngeal Carcinoma (NPC)
A Phase II Study to Evaluate HLX43 in Subjects With Recurrent/Metastatic Nasopharyngeal Carcinoma Failed or Intolerance to Second-line Therapy
The study is to explore the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in patients with recurrent/metastatic Nasopharyngeal Carcinoma (NPC) who failed or are intolerant to…
- Trial name
- NCT06839066
- Testing
- HLX43 DOSE 1, HLX43 DOSE 2, HLX43 DOSE 3
- Where
- 15 sites in China
- Volunteers
- 70 people
- Sponsor
- Shanghai Henlius Biotech
Membranous Nephropathy, Lupus Nephritis (LN)
A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis
The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis.
- Trial name
- NCT07038382
- Where
- 17 sites in China
- Volunteers
- 24 people
- Sponsor
- Shanghai Henlius Biotech
Gastric or Gastroesophageal Junction Adenocarcinoma
Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- Trial name
- NCT07115485
- Testing
- HLX43 DOSE 1, HLX43 DOSE 2, HLX43 DOSE 3
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shanghai Henlius Biotech
Colorectal Cancer (CRC)
Phase II, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) in Subjects With Advanced Colorectal Cancer
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Colorectal Cancer (CRC)
- Trial name
- NCT07106892
- Testing
- HLX43 Dose 1;, HLX43 Dose 2;, HLX43 Dose 3;
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Shanghai Henlius Biotech