Clinical trials: sponsored by Shanghai Henlius Biotech
Solid Tumor Cancer, Non Small Cell Lung Cancer
A Phase Ib/II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Patients With Advanced/Metastatic Solid Tumors
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in…
- Trial name
- NCT06848699
- Testing
- HLX43 dose 1, HLX43 dose 2, HLX43 dose 3
- Where
- 3 sites in China
- Volunteers
- 105 people
- Sponsor
- Shanghai Henlius Biotech
Extensive Stage Small Cell Lung Cancer
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC.
- Trial name
- NCT05468489
- Testing
- Serplulimab + chemotherapy (carboplatin-etoposide), Atezolizumab + chemotherapy (carboplatin-etoposide)
- Where
- 67 sites in United States
- Volunteers
- 200 people
- Sponsor
- Shanghai Henlius Biotech
Solid Tumor and NSCLC
A Study of HLX42 in Advanced/Metastatic Solid Tumors
This study is an open-label first-in-human phase I clinical study to evaluate the safety and tolerability of HLX42.
- Trial name
- NCT06210815
- Testing
- HLX42
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Shanghai Henlius Biotech
IPF
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects
The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and…
- Trial name
- NCT06310746
- Testing
- GARP/TGF-β1 monoclonal antibody
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Plaque Psoriasis
Study of Efficacy and Safety of HLX03 in Subjects With Moderate to Severe Plaque Psoriasis
This is a multicenter, randomized, double-blind, positive drug parallel-group controlled clinical study in China to evaluate efficacy, safety, tolerability and immunogenicity of HLX03 and adalimumab (Humira) in subjects with…
- Trial name
- NCT03316781
- Testing
- HLX03, adalimumab
- Where
- China
- Volunteers
- 262 people
- Sponsor
- Shanghai Henlius Biotech
NSCLC Stage IV
A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously…
- Trial name
- NCT05787613
- Testing
- HLX26, Serplulimab, Chemotherapy drug
- Where
- 3 sites in China
- Volunteers
- 132 people
- Sponsor
- Shanghai Henlius Biotech
Cancer, mCRC
Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects.
- Trial name
- NCT06980454
- Testing
- HLX05, EU-Erbitux®, US-Erbitux®
- Where
- 2 sites in China
- Volunteers
- 322 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
HER2-low Hormone Receptor Positive Breast Cancer
A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients
This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression or Intolerable Adverse…
- Trial name
- NCT06832202
- Testing
- HLX22, Trastuzumab Deruxtecan
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Henlius Biotech
Breast Cancer, Breast Neoplasms
A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
This is a phase III, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer
- Trial name
- NCT05346224
- Testing
- HLX11, EU-Perjeta®
- Where
- 79 sites in China, Hungary and 2 more
- Volunteers
- 900 people
- Sponsor
- Shanghai Henlius Biotech
Newly Diagnosed Multiple Myeloma
A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma
This is a randomized, double-blind, parallel-controlled, multicenter, phase III study to compare the efficacy and safety of HLX15-IV in combination with Rd (HLX15-IV-Rd) versus DARZALEX® in combination with Rd (D-Rd) in patients…
- Trial name
- NCT06895512
- Testing
- HLX15-IV, Darzalex
- Where
- China
- Volunteers
- 386 people
- Sponsor
- Shanghai Henlius Biotech
Age Related Macular Degeneration
Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD
this study will compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD.
- Trial name
- NCT05003245
- Testing
- HLX04-O，recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection, Lucentis
- Where
- 41 sites in China
- Volunteers
- 407 people
- Sponsor
- Shanghai Henlius Biotech
Carcinoma, Hepatocellular
A Phase II Clinical Study to Evaluate HLX43 in Patients With Locally Advanced or Metastatic HCC Failed or Intolerance to Standard Therapy
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 Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) Failed…
- Trial name
- NCT06742892
- Testing
- HLX43 DOSE 1, HLX43 DOSE 2, HLX43 DOSE 3
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Shanghai Henlius Biotech
Non-Squamous Non-Small Cell Lung Cancer
A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs.
- Trial name
- NCT06847334
- Testing
- HLX17, US-sourced Keytruda®, EU-sourced Keytruda®
- Volunteers
- 772 people
- Sponsor
- Shanghai Henlius Biotech
Hepatocellular Carcinoma (HCC)
A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma
This is a multicenter, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the efficacy, safety, PK, and immunogenicity of HLX13 and YERVOY® in patients with unresectable hepatocellular…
- Trial name
- NCT06841185
- Testing
- HLX13, US-sourced YERVOY®, EU-sourced YERVOY®
- Volunteers
- 656 people
- Sponsor
- Shanghai Henlius Biotech
Healthy Male Volunteers
Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects
Part I of the study： This is a randomised, single-dose, subcutaneous injection, parallel study designed to compare the PK of HLX14 and EU-sourced Prolia® in healthy Chinese adult male subjects, and to assess the safety…
- Trial name
- NCT04534582
- Testing
- HLX14, EU-Prolia®, US-Prolia®
- Where
- China
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Age Related Macular Degeneration
A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD
This study will compare the efficacy and safety of HLX04-O administered by intravitreal injection (IVT) with ranibizumab in patients with active wAMD.
- Trial name
- NCT04740671
- Testing
- HLX04-O, ranibizumab
- Where
- 126 sites in United States, Australia and 13 more
- Volunteers
- 410 people
- Sponsor
- Shanghai Henlius Biotech
Metastatic Colorectal Cancer (mCRC)
A Clinical Study to Compare the Efficacy, Safety and Immunogenicity of HLX04 and Bevacizumab Combined XELOX or mFOLFOX6 in the First-line Treatment of mCRC
This trial is conducted in patients with the recurrent lesion(s) post-surgery or the untreated mCRC. After stratification with respect to ECOG PS score, chemo regimen, primary tumor location and KRAS and BRAF genotype (complete…
- Trial name
- NCT03511963
- Testing
- HLX04 100 mg in 4 ml Injection, Avastin 100 mg in 4 ml Injection
- Where
- China
- Volunteers
- 677 people
- Sponsor
- Shanghai Henlius Biotech
Carcinoma, Hepatocellular
A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With…
- Trial name
- NCT06349980
- Testing
- HLX53 (1000mg), HLX53 (2000mg), HLX10
- Where
- China
- Volunteers
- 117 people
- Sponsor
- Shanghai Henlius Biotech
Metastatic Colorectal Cancer
A Clinical Study to Evaluate Efficacy and Safety of Serplulimab（HLX10） Combined With Bevacizumab（HLX04) and Chemotherapy (XELOX) in Patients With Metastatic Colorectal Cancer (mCRC)
This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the clinical efficacy of Serplulimab (HLX10) in Combination With Bevacizumab and Chemotherapy (XELOX) Versus Placebo in Combination…
- Trial name
- NCT04547166
- Testing
- HLX10, HLX04、
- Where
- 5 sites in China, Japan
- Volunteers
- 568 people
- Sponsor
- Shanghai Henlius Biotech
Colorectal Cancer Metastatic
Evaluate the Efficacy, Safety and Tolerability of HLX26 and Serplulimab in Patients with MCRC
This study is a phase II study to evaluate the efficacy, safety and tolerability of HLX26 and HLX10 in the treatment of patients with metastatic colorectal carcinoma that had received 3 prior therapies.
- Trial name
- NCT05584137
- Testing
- HLX26, HLX10
- Where
- 2 sites in China
- Volunteers
- 2 people
- Sponsor
- Shanghai Henlius Biotech