Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

HLX10

HLX04 is an recombinant anti-VEGF humanized monoclonal antibody ，developed by Shanghai Henlius Biotech, Inc.

HLX04

Sorafenib is a multi-target, multi-kinase inhibitor capable.The standard treatment of HCC.

This study is a randomized, double-blind, multicenter, phase III clinical study to compare the efficacy and safety of HLX10 + HLX04 vs Sorafenibas as the First-line Treatment in Patients with Locally Advanced or Metastatic HCC

Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:

Arm A (treatment group): HLX10 + HLX04 Arm B (control group): sorafenib Randomization is stratified by: region (Asia (excluding Japan) vs. others), HBV infection vs. HCV infection vs. no HBV or HCV infection, portal vein invasion or/and extrahepatic spread (with vs.without), and ECOG (0 vs. 1).

A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC

A Randomized, Open-Label, Controlled, Multicenter, Phase III Clinical Study to Compare the Efficacy and Safety of HLX10 (Anti-PD-1 Antibody) in Combination With HLX04 (Anti-VEGF Antibody) Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC)

Overall survival (OS): defined as a period from randomization to death of the subject for any reason.

Progression-free survival (PFS) (assessed by the independent radiology review committee \[IRRC\] based on Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)

Shanghai Henlius Biotech

HLX10, at three dose levels (1, 3, 10 mg/kg), to be intravenously injected once every two weeks; HLX04, at a fixed dose of 5 mg/kg, intravenously injected once every two weeks; Study drugs given in combination for up to 2 years or until the disease gets worse, whichever comes first.

Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection

Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection

Joanne Wang

Jin Li, MD

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.

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

A Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection (HLX10) in Combination With Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection (HLX04) in Patients With Advanced Solid Tumors

The MTD is the dose with toxicity rate (estimated by isotonic regression) most approximate to the target one (30%).

DLT is defined as the occurrence of the following adverse events (unless judged by the investigator to be definitely unrelated to HLX04 or HLX10) within Cycle 1 (i.e., from Cycle 1 Day 1 to Cycle 1 Day 28)

Peak Plasma Concentration (Cmax) for single dose and multiple doses

Area under the plasma concentration versus time curve (AUC) for single dose and multiple doses

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

HLX53+ HLX10+ HLX04 will be administered every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Placebo+ HLX10+ HLX04 will be administered every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

HLX53 will be administered by IV infusion at a fixed dose of 1000 mg on Day 1 of each 21-day cycle.

HLX53 (1000mg)

HLX53 will be administered by IV infusion at a fixed dose of 2000 mg on Day 1 of each 21-day cycle.

HLX53 (2000mg)

HLX10 will be administered by IV infusion at a fixed dose of 300 mg on Day 1 of each 21-day cycle.

HLX04 will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

Placebo matching HLX53 will be administered by IV infusion on Day 1 of each 21-day cycle.

Placebo

Jia Fan, Dr

Huichuan Sun, Dr

Jia Fan

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 or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

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.

A Randomized, Double-blind, Multi-center, Phase II Study to Evaluate the Anti-tumor Efficacy, Safety and Tolerability of HLX53 (an Anti-TIGIT Fc Fusion Protein) Combined With Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) Compared to Placebo + Serplulimab + HLX04, in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients.

Objective response rate (ORR) (assessed by the IRRC according to the RECIST v1.1 criteria)

Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC according to the RECIST v1.1 criteria.

Objective response rate (ORR) (assessed by INV according to the RECIST v1.1 criteria)

Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by INV according to the RECIST v1.1 criteria.

severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version \[v\] 5.0, vital signs and clinical laboratory test results

Lenvatinib

HLX07 1500 mg + HLX10 300 mg + HLX04 15mg/kg iv q3w

HLX07 1500 mg iv Q3w + Lenvatinib 12 mg (BW≥60 kg) or 8 mg (BW \<60 kg) po qd

HLX07

lenvatinib

Zhenggang Ren

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. Arm B will receive HLX07 combination therapy with lenvatinib as second line treatment. Arm C will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

HLX07 Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (A Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma (HCC)

Objective response rate by INV assessment per RECIST

Progression-free survival by INV assessment per RECIST

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC	NCT04465734	Hepatocellular ...	HLX10 HLX04 Sorafenib	18 Years - 75 Years	Shanghai Henlius Biotech
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	NCT03757936	Solid Tumor	HLX04 HLX10	18 Years -	Shanghai Henlius Biotech
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.	NCT06349980	Carcinoma, Hepa...	HLX53 (1000mg) HLX53 (2000mg) HLX10 HLX04 Placebo	18 Years -	Shanghai Henlius Biotech
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	NCT03757936	Solid Tumor	HLX04 HLX10	18 Years -	Shanghai Henlius Biotech
HLX07 Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma	NCT05290220	Advanced Hepato...	HLX07 HLX10 HLX04 lenvatinib	18 Years - 75 Years	Shanghai Henlius Biotech
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.	NCT06349980	Carcinoma, Hepa...	HLX53 (1000mg) HLX53 (2000mg) HLX10 HLX04 Placebo	18 Years -	Shanghai Henlius Biotech

Spots Global Cancer Trial Database for hlx04

Every month we try and update this database with for hlx04 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hlx04

Every month we try and update this database with for hlx04 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hlx04 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.