Clinical Trials List
Protocol NumberHLX06-001
NCT Number(ClinicalTrials.gov Identfier)否
2017-09-30 - 2022-09-30
Phase I
Terminated3
ICD-10C80.1
Malignant (primary) neoplasm, unspecified
A Phase 1 Study of HLX06, a Fully Human Monoclonal Antibody Targeting Human Vascular Endothelial Growth Factor Receptor-2 in Patients with Advanced Solid Tumors Refractory to Standard Therapy
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Trial Applicant
MITHRA BIOTECHNOLOGY INC.
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Sponsor
HENLIUS BIOTECH CO., LTD.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chih-Ming Chou Division of Hematology & Oncology
- Han-Lin Hsu Division of Thoracic Medicine
- Chia-Lun Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Tsu-Yi Chao Division of Hematology & Oncology
- Wei-Hong Cheng Division of Hematology & Oncology
- Yao-Yu Hsieh Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
3 Stop recruiting
Audit
CRO
Co-Principal Investigator
- Kai-Ling Lee Division of Thoracic Medicine
- Pai-Chien Chou Division of Thoracic Medicine
- Huey-En Tzeng Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Patients with Advanced Solid Tumors Refractory to Standard Therapy
Objectives
Primary objective
To identify safety and the maximum tolerated dose (MTD) of HLX06 in patients with
advanced or metastatic tumors refractory to standard therapy.
Secondary objectives
• The pharmacokinetics of HLX06 at different doses in patients.
• The pharmacodynamics of HLX06 at different doses in patients.
• The immunogenicity of HLX06 in human beings.
• The anti-tumor effects of HLX06 in patients.
• The potential prognostic and predictive biomarkers of HLX06 for advanced solid
tumors.
Test Drug
HLX06
Active Ingredient
Dosage Form
Injection
Dosage
10 mg/mL, 10 mL/vial (100 mg/vial)
250, 500, 750, 900, 1200, 1500 mg
250, 500, 750, 900, 1200, 1500 mg
Endpoints
Primary endpoints:
• Numbers and percentage of patients with adverse events (AEs).
• Maximum tolerated dose of HLX06.
Secondary endpoints:
• Maximum concentration (Cmax) in different cohorts.
• Minimum concentration (Cmin) in different cohorts.
• Area under concentration (AUC0-tau) in different cohorts.
• Half-life (T1/2) of HLX06 in different cohorts.
• Clearance (CL) rate of HLX06 in different cohorts.
• Volume of distribution (Vss) at steady state in different cohorts.
• The presence and percentage of anti-HLX06 antibody (immunogenicity).
• Disease control rate
• Overall response rate.
• Duration of response
• Numbers and percentage of patients with adverse events (AEs).
• Maximum tolerated dose of HLX06.
Secondary endpoints:
• Maximum concentration (Cmax) in different cohorts.
• Minimum concentration (Cmin) in different cohorts.
• Area under concentration (AUC0-tau) in different cohorts.
• Half-life (T1/2) of HLX06 in different cohorts.
• Clearance (CL) rate of HLX06 in different cohorts.
• Volume of distribution (Vss) at steady state in different cohorts.
• The presence and percentage of anti-HLX06 antibody (immunogenicity).
• Disease control rate
• Overall response rate.
• Duration of response
Inclution Criteria
Eligible patients must be 18-years of age or older or per local regulations.
Patients with histologically-proven measurable or evaluable advanced or metastatic solid tumors who have failed standard therapy or for whom no standard therapy is available. (For patients with hepatocellular carcinoma, the diagnosis needs to be supported by dynamic CT/MRI, if pathological confirmation is not attainable.)
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at the time of study entry.
Able to provide informed consent.
A life expectancy longer than three months.
Adequate hematologic functions, as defined by: absolute neutrophil counts ≥ 1500/mm3; a hemoglobin level ≥ 10 gm/dL; a platelet count ≥ 100,000/mm3.
Adequate hepatic function defined by: a total bilirubin level ≤ 1.5x of upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x of ULN or ≤ 5x of ULN in known hepatic metastases or with primary hepatocellular carcinoma.
Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute by Cockcroft-Gault formula.
Adequate cardiac function defined as left ventricular ejection fraction (LVEF)≥ 50%.
Use of effective contraceptive measures if procreative potential exists.
At least 28 days from prior major surgery, prior cytotoxic chemotherapy, or prior therapy with investigational agents (or medical device) or local radiotherapy before 1st infusion of HLX06.
For patients with hepatocellular carcinoma, their Child-Pugh score has to be A.
Able to be followed up as required by the study protocol.
Patients with histologically-proven measurable or evaluable advanced or metastatic solid tumors who have failed standard therapy or for whom no standard therapy is available. (For patients with hepatocellular carcinoma, the diagnosis needs to be supported by dynamic CT/MRI, if pathological confirmation is not attainable.)
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at the time of study entry.
Able to provide informed consent.
A life expectancy longer than three months.
Adequate hematologic functions, as defined by: absolute neutrophil counts ≥ 1500/mm3; a hemoglobin level ≥ 10 gm/dL; a platelet count ≥ 100,000/mm3.
Adequate hepatic function defined by: a total bilirubin level ≤ 1.5x of upper limit of normal (ULN); aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤ 2.5 x of ULN or ≤ 5x of ULN in known hepatic metastases or with primary hepatocellular carcinoma.
Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute by Cockcroft-Gault formula.
Adequate cardiac function defined as left ventricular ejection fraction (LVEF)≥ 50%.
Use of effective contraceptive measures if procreative potential exists.
At least 28 days from prior major surgery, prior cytotoxic chemotherapy, or prior therapy with investigational agents (or medical device) or local radiotherapy before 1st infusion of HLX06.
For patients with hepatocellular carcinoma, their Child-Pugh score has to be A.
Able to be followed up as required by the study protocol.
Exclusion Criteria
Patients with large centrally located pulmonary lesions adjacent to or invading large blood vessels.
Hemoptysis more than ½ teaspoon (approximately 2-3 mL) of red blood per day.
Patients who still have ≥ grade 2 toxicities from prior therapies.
Concurrent unstable or uncontrolled medical conditions with either of the followings:
o Active systemic infections;
o Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg), or poor compliance with anti-hypertensive agents;
o Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class III or IV of New York Heart Association [NYHA]) or acute myocardial infarction within 6 months;
o Uncontrolled diabetes or poor compliance with hypoglycemics;
o The presence of chronically unhealed wound or ulcers
o Other chronic diseases, which, in the opinion of the investigator, could compromise safety of the patient or the integrity of study.
Newly-diagnosed or symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids for brain edema). Anticonvulsants are allowed.
Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 3 years are allowed to participate).
Pregnancy (confirmed by serum beta human chorionic gonadotropin [ßHCG]) or breast-feeding (for female patients only).
A known history or clinical evidence of a deep vein or arterial thrombosis, or pulmonary embolism within 6 months of first infusion of HLX06.
Less than six weeks from last infusion of ramucirumab, or any other anti-VEGF monoclonal antibody therapy (last treatment with other monoclonal antibodies targeting proteins other than anti-angiogenic factors is permitted if ≥ 4 weeks prior to the first infusion of HLX06).
Proteinuria ≥ 2+ in routine urinalysis (patients with a protein value of ≤500 mg confirmed by a 24-hour urine collection are eligible).
Known history of human immunodeficiency virus infection (HIV).
The patient is the investigator, sub-investigator or any one directly involved in the conduct of the study.
Hemoptysis more than ½ teaspoon (approximately 2-3 mL) of red blood per day.
Patients who still have ≥ grade 2 toxicities from prior therapies.
Concurrent unstable or uncontrolled medical conditions with either of the followings:
o Active systemic infections;
o Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg), or poor compliance with anti-hypertensive agents;
o Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class III or IV of New York Heart Association [NYHA]) or acute myocardial infarction within 6 months;
o Uncontrolled diabetes or poor compliance with hypoglycemics;
o The presence of chronically unhealed wound or ulcers
o Other chronic diseases, which, in the opinion of the investigator, could compromise safety of the patient or the integrity of study.
Newly-diagnosed or symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids for brain edema). Anticonvulsants are allowed.
Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 3 years are allowed to participate).
Pregnancy (confirmed by serum beta human chorionic gonadotropin [ßHCG]) or breast-feeding (for female patients only).
A known history or clinical evidence of a deep vein or arterial thrombosis, or pulmonary embolism within 6 months of first infusion of HLX06.
Less than six weeks from last infusion of ramucirumab, or any other anti-VEGF monoclonal antibody therapy (last treatment with other monoclonal antibodies targeting proteins other than anti-angiogenic factors is permitted if ≥ 4 weeks prior to the first infusion of HLX06).
Proteinuria ≥ 2+ in routine urinalysis (patients with a protein value of ≤500 mg confirmed by a 24-hour urine collection are eligible).
Known history of human immunodeficiency virus infection (HIV).
The patient is the investigator, sub-investigator or any one directly involved in the conduct of the study.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
0 participants
