Clinical trials: sponsored by Shanghai Henlius Biotech
Health 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
Non-small Cell Lung Cancer, Melanoma
A Phase I Clinical Study to Evaluate the PK Profile, Efficacy, Safety and Immunogenicity of HLX17 vs. Keytruda® 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 HLX17 vs.
- Conditions
- Non-small Cell Lung Cancer, Melanoma, Renal Cell Carcinoma
- Trial name
- NCT07160335
- Testing
- HLX17, US-sourced Keytruda®
- Where
- 69 sites in United States, China and 2 more
- Volunteers
- 174 people
- 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
Advanced/Metastatic Solid Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and PK of HLX48 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 HLX48 in patients with advanced/metastatic solid tumors.
- Trial name
- NCT07473726
- Testing
- HLX48
- Where
- 7 sites in Australia, China
- Volunteers
- 72 people
- Sponsor
- Shanghai Henlius Biotech
Non Small Cell Lung Cancer
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC
The study is being conducted to to explore the reasonable dosage and evaluate the efficacy and safety of HLX43 (Anti-PD-L1 ADC) in Combination with Serplulimab (Anti-PD-1 Recombinant Humanized Monoclonal Antibody) as Neoadjuvant…
- Trial name
- NCT07269782
- Testing
- HLX43 DOSE 1, HLX43 DOSE 2, Serplulimab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shanghai Henlius Biotech
Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
This is a randomized, open-label, multi-center, global phase II/III clinical study to evaluate the efficacy and safety of HLX43 monotherapy or HLX43 in combination with HLX07 vs.
- Trial name
- NCT07459751
- Testing
- HLX43, HLX43+HLX07, Docetaxel
- Where
- China
- Volunteers
- 706 people
- Sponsor
- Shanghai Henlius Biotech
Advanced/Metastatic Solid Tumors
A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors
This study is an open-label, first-in-human Phase I clinical study to evaluate the safety, tolerability, PK characteristics, and preliminary antitumor activity of HLX316 in participants with advanced/metastatic solid tumors.
- Trial name
- NCT07541534
- Testing
- HLX316
- Where
- 5 sites in China
- Volunteers
- 41 people
- Sponsor
- Shanghai Henlius Biotech
HER2 + Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .
- Trial name
- NCT07601620
- Testing
- HLX319, EU-Phesgo®
- Volunteers
- 258 people
- Sponsor
- Shanghai Henlius Biotech
SCLC, Extensive Stage
A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC
Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients…
- Trial name
- NCT06812260
- Testing
- HLX10+chemo
- Where
- Japan
- Volunteers
- 26 people
- Sponsor
- Shanghai Henlius Biotech
Esophageal Cancer
A Phase II Clinical Study to Evaluate HLX43 in Patients With Recurrent/Metastatic ESCC Failed or Intolerance to Standard Therapy
The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Recurrent/Metastatic Esophageal Squamous Cell Carcinomar (ESCC) Failed or…
- Trial name
- NCT06769113
- Testing
- HLX43
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Shanghai Henlius Biotech
mCRC
A Phase I Multicentre Randomized Double-Blind Parallel-Controlled Study of HLX05-N vs. ERBITUX® in Metastatic Colorectal Cancer
This is a multicentre, randomized, double-blind, parallel-controlled Phase 1 clinical study designed to evaluate the pharmacokinetic (PK) similarity, efficacy, safety, and immunogenicity of HLX05-N compared with US-sourced…
- Trial name
- PK similarity (NCT07543471)
- Testing
- Cetuximab, mFOLFOX6
- Volunteers
- 387 people
- Sponsor
- Shanghai Henlius Biotech
Cervical Cancer, Ovarian Cancer
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) in Patients With Advanced Gynecological Malignant 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 patients with recurrent/metastatic cervical cancer or ovarian cancer failed or…
- Trial name
- NCT06769152
- Testing
- HLX43
- Where
- China
- Volunteers
- 190 people
- Sponsor
- Shanghai Henlius Biotech