Symptoms and General Pathology

All Conditions

Recurrence

All Drugs and Chemicals

Antiemetics

Dermatologic Agents

Gastrointestinal Agents

Anti-Inflammatory Agents

Antineoplastic Agents

Antipyretics

Analgesics

Anti-Allergic Agents

Central Nervous System Depressants

Antibodies

Antibodies, Monoclonal

Ondansetron

Dexamethasone

Acetaminophen

Dexamethasone acetate

BB 1101

Immunoglobulins

Diphenhydramine

Promethazine

Serotonin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Analgesics, Non-Narcotic

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Each cycle of treatment consists of 4 weeks. Patients who enroll into this study will receive weekly infusion of assigned dose of HLX07. No intra-patient dose escalation is allowed.The proposed dose escalation sequence is 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg.

Acetaminophen 500 mg PO 30 minutes before the infusion of HLX07, followed by dexamethasone 10 mg intravenous infusion for 10 minutes, and followed by diphenhydramine 30 mg intravenous infusion for 10 minutes. If the patient experience grade 2 or 3 nausea and vomiting during the first infusion of HLX07, the addition of 5-HT3 inhibitor may be included in the premedication before subsequent infusions.

recombinant human anti-EGFR monoclonal antibody against cancers

HLX07

Acetaminophen 500 mg PO 30 minutes before the infusion of HLX07.

dexamethasone 10 mg intravenous infusion for 10 minutes before the infusion of HLX07.

dexamethasone

diphenhydramine 30 mg intravenous infusion for 10 minutes before the infusion of HLX07.

diphenhydramine

If the patient experience grade 2 or 3 nausea and vomiting during the first infusion of HLX07, the addition of 5-HT3 inhibitor may be included in the premedication before subsequent infusions.

5-HT3 inhibitor

Weidong Jiang, Ph.D.

This study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of humanized anti-EGFR monoclonal antibody, HLX07, in patients with epithelial cancer who have failed standard therapy and deemed unamenable by conventional therapy. This study will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX07 and explore the potential prognostic and predictive biomarkers.

The role of EGFR in carcinogenesis led to the development and extensive evaluation of EGFR-blocking agents for cancer treatment. Two EGFR-targeted approaches have been explored: (a) small-molecule tyrosine kinase inhibitors targeting the intracellular EGFR tyrosine kinase domain and (b). mAbs targeting the EGFR extra-cellular domain.

Small-molecule tyrosine kinase inhibitors have been widely used in lung cancer with EGFR mutations. However, the results of using small molecule inhibitors for cancer with overexpressed wildtype EGFR have been unsatisfactory.

The best-studied of the anti-EGFR mAbs in cancer is cetuximab (Erbitux®), and panitumumab (Vectibix®). Necitumumab, another humanized anti-EGFR mAb is currently under investigation is multiple cancers. Both cetuximab and panitumumab have been approved in colorectal cancer and head/neck cancer.

Cetuximab is chimeric human-murine IgG1 mAb, and blocks ligand binding to EGFR, thereby diminishing receptor dimerization and autophosphorylation and inducing EGFR downregulation. The immunoglobulin IgG1 isotype of cetuximab may also engage hose immune functions such as antibody-dependent cellular cytotoxicity (ADCC). Cetuximab is approved to be used in combination with chemotherapy and has been shown to improve the survival of patients with advanced colorectal cancer. Cetuximab, when used in combination with radiotherapy has also improved response rate in patients with locally advanced head/neck cancer. However, the use of cetuximab has been associated with rare anaphylactic reactions, which is likely to be related to the specific glycosylation in the molecules and possibly its mouse/human chimeric structure.

Panitumumab is a human IgG2 mAb that targets EGFR. But unlike cetuximab, it mediates its effects through mechanisms other than ADCC, which has a different binding site on EGFR extracellular domain from that of cetuximab, is also approved for colorectal cancer and head/neck cancer. However, the side effects, especially skin reactions, is more pronounced in patients receiving panitumumab, which also limiting its clinical use.

Although cetuximab and panitumumab target EGFR, clinical studies of cetuximab and panitumumab have shown that the levels of EGFR expression in cancer cells do not affect the efficacy of the drug.So far there is unclear why it is so. However, several retrospective studies have shown that the presence of K-ras, and B-raf mutations predicts the poor response to either cetuximab or panitumumab. Likewise, there is no clear answer for such phenomenon. Therefore, in this study, the investigators will examine the expression of EGFR in the cancer cells of enrolled patients, but will not use its expression for enrollment. But, in this study, the investigators will exclude patients whose cancer cells harbor either K-ras, or B-raf mutations, since the investigators in vivo study also demonstrated that HLX07 is not effective in cancer cells with K-ras mutations.

HLX07 is an improved version of anti-EGFR monoclonal antibody. There are several important improvements in the development of HLX07. First, the investigators re-engineered the Fab portion of the antibody to modify the glycosylation pattern of this antibody- to make less immunogenic and have better binding affinity. Second, the investigators produced an antibody using CHO cell system, which lead to cleaner glycosylation profile and better yield. Therefore, the investigators expect that the results can provide a better and more affordable option for patients with advanced cancer.

The investigators in vitro and in vivo animal studies have demonstrated that the anti-cancer effect of HLX07 at the same dose level is either equal or superior to those of cetuximab. In the toxicokinetic studies on monkey, the toxicity profile of HLX07 was better than that of cetuximab. Therefore, the investigators are confident that HLX07 will be a better solution for patients who benefit from anti-EGFR monoclonal antibody therapy.

However, HLX07 has not been tested in human yet. Therefore, the investigators propose this first-in-human phase 1 study. In this study, the investigators intend to investigate the safety, and tolerability of HLX07 in humans, and hope to identify the maximum tolerated dose, and determine the recommended phase 2 dose in future study. At the same time, the investigators would like to gain information of the pharmacokinetics and pharmacodynamics of this drug and its potential immunogenicity.

To minimize the risk of patients who volunteer to receive this experimental drug, the investigators will choose 50 mg flat dose as the initial starting dose. The selection of starting dose is based on the repeat-dose toxicology study on monkey. In the 3-month repeat-dose study, the highest non-severely toxic dose (HNSTD) is weekly 60 mg/kg. The human equivalent dose for this HNSTD is 20 mg/kg. One-sixth of 20 mg/kg in an adult of 70 kilogram is 233 mg. In order to provide sufficient safety factor in the FIH study, the investigators will select 50 mg flat dose as the starting dose in this study.

To investigate the dose required to reach maximal effect, the investigators propose a dose escalation sequence. The purpose of the dose escalation is to obtain the pharmacokinetics and pharmacodynamics of HLX07 at different dose levels, and investigate its relationship with adverse reactions. Also, the investigators intend to identify the MTD and determine the dose required to reach 90% saturation of clearance. The information from the dose escalation is crucial to determine the optimal dose in future studies and potential indications for HLX07.

Prospective, open-label, dose-escalation study of HLX07 ,3+3 design

An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers

A Prospective,Open-label, Dose Escalation Phase 1 Study to Investigate the Safety, and Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of a HLX07, in Patients With Advanced Solid Cancers.

Patients will receive CT/MRI imaging studies every 8 weeks for treatment response until disease progression, withdrawal from the study or death, whichever occurs first.

Henlix, Inc

Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Gemcitabine

Cisplatin

HLX10

placebo

gemcitabine 1000 mg/m2, D1,D8; cisplatin 80 mg/m2,D1；Q3W, up to 6 cycles

chemotherapy

Li Zhang

A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC

A Randomized, Double-Blind, Multi-Center Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) + Serplulimab (HLX10, Recombinant Anti-PD-1 Humanized Monoclonal Antibody) +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

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 and INV according to the RECIST v1.1 criteria.

Shanghai Henlius Biotech

Digestive System Diseases

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Carcinoma, Adenosquamous

Fluorouracil

EGFR H score ≥ 200, as third-line or above therapy

EGFR H score \<200, as third-line or above therapy

HLX07 1000mg + HLX10 200mg + Cisplatin 50 mg/m2 + 5-FU 2400mg/m2

HLX07+HLX10+ Cisplatin+5-FU

Jing Huang

Wu Zhuang

Feng Ye

Ying wang

Tao Wu

Zhenbo Tan

Ning Li

Zhenyang Liu

Guochun Cao

Lianke Liu

Yuan Yuan

Bo Liu

Junye Wang

Jiayan Chen

Mudan Yang

Jin Zhou

qing Bi

This study is conducted in patients with Locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma. This study includes three arms: A, B1, and B2. Arm A will receive HLX07 combination therapy with HLX10 and Chemotherapy (Cisplatin+5-FU) as first line treatment. Arm B (Patients with EGFR expression H score ≥ 200) and Arm C (Patients with EGFR expression H score \< 200) 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).

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC

An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 ( Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Monotherapy in Patients With Locally Advanced, Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

Objective response rate by IRRC/INV assessment per RECIST

Progression-free survival by IRRC/INV assessment per RECIST

This study uses the "3+3" design to investigate the safety and determine the MTD of HLX07. Four dose levels of 800 mg, 1200 mg, 1500 mg and 1800 mg are planned for dose finding. Enrollment will continue until a maximum of 24 patients are enrolled.

A Recombinant Humanized Anti-EGFR Monoclonal Antibody, HLX07 will be administered as a single intravenous (IV) infusion on Day 1 in each 3-week cycle

Xuhui Hu, MD

Jian Zhang, MD

This Phase1, open-label and dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX07 administered as a single-agent by IV infusion every 3 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available.

HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors

A Phase I Clinical Study To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) in Patients With Advanced or Metastatic Solid Tumors

Respiratory Tract (Lung and Bronchial) Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Carboplatin

Etoposide

Etoposide phosphate

Enzyme Inhibitors

HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)

HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.

HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.

carboplatin and etoposide

Ying Cheng, MD

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) as first-line 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).

A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer

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 Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)

Objective response rate by investigator assessment per RECIST 1.1

Progression-free survival by investigator assessment per RECIST v1.1

Carcinoma, Hepatocellular

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Lenvatinib

Protein Kinase Inhibitors

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

HLX04

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

HLX07 \* 1000 mg+HLX10\* 200mg +mFOLFOX6, IV, Q2W

OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2

mFOLFOX6

Peng Junjie

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 Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.

Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC

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 Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer

Objective response rate (assessed by investigator per RECIST V1.1)

Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 )

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Capecitabine

Oxaliplatin

Antimetabolites

HER2 negative and PD-L1 CPS≥5, as first-line therapy

HLX07 1500mg+HLX10 300mg+oxaliplatin 130mg/m2+capecitabine 1000mg/m2 q3w

HLX07+HLX10+oxaliplatin+capecitabine

Dazhi Xu, MD

Peng Nie, MD

This study is conducted in patients with advanced metastatic gastric cancer including gastroesophageal junction cancer. This study includes two arms: A and B. Arm A (patients with HER2 negative and PD-L1 CPS≥5 ) will receive HLX07 combination therapy with HLX10 and chemotherapy (oxaliplatin+capecitabine) as first-line treatment. Arm B 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+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer

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 Injection) + Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer

Objective response rate by IRRC assessment per RECIST 1.1

Progression-free survival by IRRC assessment per RECIST 1.1

Objective response rate by INV assessment per RECIST 1.1

Duration of response by IRRC/INV assessment per RECIST 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers	NCT02648490	Solid Tumour	HLX07 Acetaminophen dexamethasone diphenhydramine 5-HT3 inhibitor	18 Years -	Henlix, Inc
Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC	NCT05513573	Nasopharyngeal ...	HLX07 HLX10 placebo chemotherapy	18 Years -	Shanghai Henlius Biotech
An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers	NCT02648490	Solid Tumour	HLX07 Acetaminophen dexamethasone diphenhydramine 5-HT3 inhibitor	18 Years -	Henlix, Inc
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC	NCT05221658	ESCC or Esophag...	HLX07+HLX10+ Ci... HLX07	18 Years - 75 Years	Shanghai Henlius Biotech
HLX07(Anti-EGFR mAb) in Patients With Advanced or Metastatic Solid Tumors	NCT05360368	Solid Tumor	HLX07	18 Years - 75 Years	Shanghai Henlius Biotech
A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer	NCT05354700	Small-cell Lung...	HLX07 HLX10 carboplatin and...	18 Years -	Shanghai Henlius Biotech
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC	NCT05221658	ESCC or Esophag...	HLX07+HLX10+ Ci... HLX07	18 Years - 75 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
Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC	NCT05239650	CRC	HLX07 HLX10 mFOLFOX6	18 Years - 75 Years	Shanghai Henlius Biotech
HLX07+HLX10+Chemotherapy or HLX07 Monotherapy in Patients With Advanced Metastatic Gastric Cancer	NCT05246982	Gastric Cancer ...	HLX07+HLX10+oxa... HLX07	18 Years - 75 Years	Shanghai Henlius Biotech

Spots Global Cancer Trial Database for hlx07

Every month we try and update this database with for hlx07 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 hlx07

Every month we try and update this database with for hlx07 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 hlx07 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.