Pharmaceutical sponsor
Shanghai Henlius Biotech Clinical Trials
Studies where Shanghai Henlius Biotech is the lead sponsor: its pipeline by phase, what is enrolling now and where. Studies it supports as a collaborator are in the search.
In numbers
Open to volunteers: recruiting, not yet recruiting or enrolling by invitation. Active adds studies under way that have stopped recruiting.
Open to volunteers
All 47Health Adult Subjects
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult…
- Trial name
- NCT07776132
- Testing
- HLX29, HLX11
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Advanced/Metastatic Malignant Solid Tumors
A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 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 HLX43 in patients with advanced/metastatic solid tumors.
- Trial name
- NCT06115642
- Testing
- HLX43, HLX10
- Where
- 14 sites in United States, China and 1 more
- Volunteers
- 367 people
- Sponsor
- Shanghai Henlius Biotech
NSCLC (Advanced Non-small Cell Lung Cancer)
A Study to Learn the Safety and Efficacy of HLX37 in Combination With Chemotherapy for First-line Treatment in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This is a Randomized, Double-Blind, Multicenter, Phase II/III Study to Evaluate HLX37 (Recombinant Human Anti-PD-L1 and Anti-VEGF Bispecific Antibody) in Combination with Chemotherapy Versus Pembrolizumab in Combination with…
- Trial name
- NCT07865910
- Testing
- Investigational drug: HLX37 dose1, IV, Q3W, PEMBROLIZUMAB (alone or when added to a regimen above), Carboplatin (Investigator discretion)
- Where
- 16 sites in China
- Volunteers
- 1,438 people
- Sponsor
- Shanghai Henlius Biotech
Non Small Cell Lung Cancer
A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)
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 Non-small Cell Lung Cancer (NSCLC)
- Trial name
- NCT06907615
- Testing
- HLX43 DOSE 1 (2.0 mg/kg), HLX43 DOSE 2 (2.5 mg/kg)
- Where
- 2 sites in United States, China
- Volunteers
- 243 people
- Sponsor
- Shanghai Henlius Biotech
Multiple Myeloma (MM)
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in…
- Trial name
- NCT07477587
- Testing
- HLX15-SC-Rd, US-DARZALEX FASPRO®-Rd
- Where
- 84 sites in United States, Australia and 3 more
- Volunteers
- 258 people
- Sponsor
- Shanghai Henlius Biotech
HER2 + Breast Cancer
A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients
This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously…
- Trial name
- NCT07824869
- Testing
- HLX22, Trastuzumab, Capecitabine
- Volunteers
- 90 people
- Sponsor
- Shanghai Henlius Biotech
mCRPC or Advanced/Metastatic Solid Tumors
A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tumours
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3902 in patients with mCRPC and other advanced solid tumours.
- Trial name
- NCT07533708
- Testing
- HLX3902
- Where
- 5 sites in China
- Volunteers
- 48 people
- Sponsor
- Shanghai Henlius Biotech
Esophageal and/or Cardia Cancer, Melanoma
A Study of HLX18 vs. OPDIVO® in Multiple Resected Solid Tumors
This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal…
- Conditions
- Esophageal and/or Cardia Cancer, Melanoma, Urothelial Carcinoma (UC)
- Trial name
- NCT07518043
- Testing
- HLX18, OPDIVO®
- Where
- 7 sites in China
- Volunteers
- 174 people
- Sponsor
- Shanghai Henlius Biotech
Non Small Cell Lung Cancer, Small Cell Lung Cancer
A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer
The study is to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients…
- Trial name
- NCT07253142
- Testing
- HLX43 dose 1, HLX43 dose 2
- Where
- 10 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai Henlius Biotech
SCLC, NEC
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HLX3901 in Patients With Advanced SCLC or NEC
This study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX3901 in patients with Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma.
- Trial name
- NCT07416695
- Testing
- HLX3901
- Where
- 2 sites in China
- Volunteers
- 138 people
- Sponsor
- Shanghai Henlius Biotech
Completed, with results posted
All 2Extensive 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
Breast Cancer
Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer
This is a Phase III, double-blind, randomized multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of HLX02 and European Union (EU)-sourced Herceptin® in patients with human epidermal growth…
- Trial name
- NCT03084237
- Testing
- HLX02, Herceptin®, docetaxel
- Where
- 88 sites in China, Philippines and 1 more
- Volunteers
- 652 people
- Sponsor
- Shanghai Henlius Biotech