Clinical trials: sponsored by Shanghai Henlius Biotech
Small-cell Lung Cancer
A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer
This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide)…
- Trial name
- NCT05354700
- Testing
- HLX07, HLX10, carboplatin and etoposide
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Henlius Biotech
Advanced Hepatocellular Carcinoma
HLX07 Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma
This study is conducted in patients with advanced hepatocellular carcinoma (HCC). This study includes three arms: A, B, and C. Arm A will receive HLX07 combination therapy with HLX10 and HLX04 as first line treatment.
- Trial name
- NCT05290220
- Testing
- HLX07, HLX10, HLX04
- Volunteers
- 60 people
- Sponsor
- Shanghai Henlius Biotech
Advanced Melanoma
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation
- Trial name
- NCT05114603
- Testing
- HLX208
- Where
- 7 sites in China
- Volunteers
- 30 people
- Sponsor
- Shanghai Henlius Biotech
Brain Tumor, Primary
The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation
- Trial name
- NCT05092802
- Testing
- HLX208
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Henlius Biotech
CRC
Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC
This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody…
- Trial name
- NCT05239650
- Testing
- HLX07, HLX10, mFOLFOX6
- Volunteers
- 50 people
- Sponsor
- Shanghai Henlius Biotech
Gastric Cancer (GC) Gastroesophageal Junction Cancer (GEJ)
HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer
This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B.
- Trial name
- NCT05246982
- Testing
- HLX07+HLX10+oxaliplatin+capecitabine, HLX07
- Where
- 2 sites in China
- Volunteers
- 40 people
- Sponsor
- Shanghai Henlius Biotech
NSCLC
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Non-small Cell Lung Cancer Patients With BRAF V600 Mutation
Evaluate the efficacy，safety and pharmacokinetics of HLX208 in advanced non-small cell lung cancer patients with BRAF V600 mutation
- Trial name
- NCT05065398
- Testing
- HLX208
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Henlius Biotech
Hepatocellular Carcinoma
A Clinical Study Evaluating the Use of HLX10 in Combination With HLX04 for the Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients
This trial is a single-arm, open, multicenter phase II clinical study.Subjects can only enter this study after they meet the inclusion and exclusion criteria.Into subjects will accept HLX10 + HLX04 intravenous infusion, every two…
- Trial name
- NCT03973112
- Testing
- HLX10 3mg/kg, HLX04 5mg/kg, HLX04 10mg/kg
- Where
- China
- Volunteers
- 123 people
- Sponsor
- Shanghai Henlius Biotech
CD20-positive Follicular Lymphoma, With Low Tumour Burden
Evaluate the Efficacy and Safety of HLX01 Versus Mabthera in Patients With Low Tumour Burden Follicular Lymphoma.
The study is a Phase 3 multi-centre, randomised, double-blind, parallel-arm study to evaluate the efficacy and safety of HLX01 versus European Union (EU)-sourced Mabthera® as first line treatment in patients with low tumour…
- Trial name
- NCT04671420
- Testing
- HLX01, Mabthera®
- Sponsor
- Shanghai Henlius Biotech
Triple Negative Breast Cancer
to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)
This study is a randomized, double-Blind,international multi-Centre, phase III clinical study to evaluate efficacy and safety of HLX10 in combination with chemotherapy versus placebo in combination with chemotherapy as…
- Trial name
- NCT04301739
- Testing
- HLX10, nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide
- Volunteers
- 522 people
- Sponsor
- Shanghai Henlius Biotech
Solid Tumor
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Anti-PD-1 Antibody (HLX10) in Combination With Avastin Biosimilar (HLX04) in Patients With Advanced Solid Tumors
This is a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX10-HLX04 combination therapy in patients with advanced solid tumors after failure of standard of care.
- Trial name
- NCT03757936
- Testing
- HLX04, HLX10
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Henlius Biotech