Clinical Trials List
Protocol NumberHLX10-001
2018-01-01 - 2020-06-30
Phase I
Recruiting5
ICD-10C80.1
Malignant (primary) neoplasm, unspecified
A PHASE 1 STUDY OF HLX10, A HUMANIZED MONOCLONAL ANTIBODY TARGETING PROGRAMMED DEATH-1 (PD-1) PROTEIN IN PATIENTS WITH ADVANCED SOLID TUMORS
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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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
- 戴明燊 Division of Hematology & Oncology
- 陳佳宏 Division of Hematology & Oncology
- 張平穎 Division of Hematology & Oncology
- 葉人華 Division of Hematology & Oncology
- 陳宇欽 Division of Hematology & Oncology
- 黃子權 Division of Hematology & Oncology
- 吳宜穎 Division of Hematology & Oncology
- 賴學緯 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Min Yeh 無
- 蘇文 彬 無
- Nai-Jung Chiang Division of General Internal Medicine
- Wen-Pin Su Division of General Internal Medicine
- 姜乃榕 Division of General Internal Medicine
- Wu-Chou Su 無
- Jui-Hung Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yao-Yu Hsieh Division of Hematology & Oncology
- Tsu-Yi Chao Division of Hematology & Oncology
- 蘇勇誠 Division of Hematology & Oncology
- Wei-Hong Cheng Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
5 Recruiting
Audit
None
Co-Principal Investigator
- Ming-Shun Wu Division of Hematology & Oncology
- Han-Lin Hsu Division of Hematology & Oncology
- Chih-Ming Chou Division of Hematology & Oncology
- Ming-Hung Hu Division of Hematology & Oncology
- Chih-Shiang Chang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
solid tumor
Objectives
Primary Objective:
To identify safety and the maximum tolerated dose (MTD) of HLX10 in patients with advanced
or metastatic tumors refractory to standard therapy.
Secondary Objectives:
• The pharmacokinetics of HLX10 at different doses in patients.
• The pharmacodynamics of HLX10 at different doses in patients.
• The immunogenicity of HLX10 in human beings.
• The anti-tumor effects of HLX10 and its duration of response in patients.
• The potential predictive and prognostic biomarkers of HLX10 for advanced solid
tumors.
Test Drug
HLX10
Active Ingredient
HLX10
Dosage Form
intravenous injection
Dosage
10 mg/mL, 10 mL/vial
Endpoints
Primary endpoints:
• Numbers and percentage of patients with adverse events (AEs).
• Maximum tolerated dose of HLX10.
Secondary endpoints:
• The pharmacokinetic parameters of HLX10 at different doses in patients with advanced
solid tumors, including but not limited to:
o Maximum concentration (Cmax) of HLX10 in different cohorts.
o Minimum concentration (Cmin) of HLX10 in different cohorts.
o Area under concentration (AUC0-tau) in different cohorts.
o Half-life (T1/2) of HLX10 in different cohorts.
o Clearance (CL) rate of HLX10 in different cohorts.
o Volume of distribution (Vss) at steady state in different cohorts.
• The pharmacodynamics of HLX10 at different doses in patients with advanced solid
tumors.
o Receptor occupancy of PD-1 on human T cells.
o Target engagement assessed by measuring the IL-2 stimulation.
• The presence and percentage of anti-HLX10 antibody (immunogenicity).
• Disease control rate.
• Overall response rate.
• Duration of response.
• Potential predictive and prognostic biomarkers.
• Numbers and percentage of patients with adverse events (AEs).
• Maximum tolerated dose of HLX10.
Secondary endpoints:
• The pharmacokinetic parameters of HLX10 at different doses in patients with advanced
solid tumors, including but not limited to:
o Maximum concentration (Cmax) of HLX10 in different cohorts.
o Minimum concentration (Cmin) of HLX10 in different cohorts.
o Area under concentration (AUC0-tau) in different cohorts.
o Half-life (T1/2) of HLX10 in different cohorts.
o Clearance (CL) rate of HLX10 in different cohorts.
o Volume of distribution (Vss) at steady state in different cohorts.
• The pharmacodynamics of HLX10 at different doses in patients with advanced solid
tumors.
o Receptor occupancy of PD-1 on human T cells.
o Target engagement assessed by measuring the IL-2 stimulation.
• The presence and percentage of anti-HLX10 antibody (immunogenicity).
• Disease control rate.
• Overall response rate.
• Duration of response.
• Potential predictive and prognostic biomarkers.
Inclution Criteria
1. Eligible patients must be 18 years of age or older or per local regulations.
2. Patients with histologically-proven measurable or evaluable advanced (systemically or locally progressive) or metastatic solid tumors who have failed or are intolerant to standard therapy or for whom no standard therapy is available or the locally advanced disease is not amenable to local therapy. (For patients with hepatocellular carcinoma, the diagnosis needs to be supported by dynamic CT/MRI, if pathological confirmation is not attainable)
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at the time of study entry.
4. Able to provide informed consent.
5. A life expectancy longer than three months.
6. Adequate hematologic functions, as defined by: absolute neutrophil counts ≥ 1500/mm3 ; a hemoglobin level ≥ 10 gm/dL; a platelet count ≥ 100,000/mm3 .
7. 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.
8. Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute by Cockcroft-Gault formula.
9. Adequate cardiac function defined as left ventricular ejection fraction (LVEF)≥ 50%.
10.Use of effective contraceptive measures if procreative potential exists .
11.At least 28 days from prior major surgery or medical device or local radiotherapy or prior therapy with investigational agents, or five half-lives from prior cytotoxic chemotherapy, and at least 42 days from the last infusion of immune check point inhibitors (including anti-PD-1 or anti-PD-L1) before the first infusion of investigational product
12.For patients with hepatocellular carcinoma, their Child-Pugh score has to be A.
13.Able to be followed up as required by the study protocol.
2. Patients with histologically-proven measurable or evaluable advanced (systemically or locally progressive) or metastatic solid tumors who have failed or are intolerant to standard therapy or for whom no standard therapy is available or the locally advanced disease is not amenable to local therapy. (For patients with hepatocellular carcinoma, the diagnosis needs to be supported by dynamic CT/MRI, if pathological confirmation is not attainable)
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 at the time of study entry.
4. Able to provide informed consent.
5. A life expectancy longer than three months.
6. Adequate hematologic functions, as defined by: absolute neutrophil counts ≥ 1500/mm3 ; a hemoglobin level ≥ 10 gm/dL; a platelet count ≥ 100,000/mm3 .
7. 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.
8. Adequate renal function, as defined by the creatinine clearance rate ≥ 50 mL/minute by Cockcroft-Gault formula.
9. Adequate cardiac function defined as left ventricular ejection fraction (LVEF)≥ 50%.
10.Use of effective contraceptive measures if procreative potential exists .
11.At least 28 days from prior major surgery or medical device or local radiotherapy or prior therapy with investigational agents, or five half-lives from prior cytotoxic chemotherapy, and at least 42 days from the last infusion of immune check point inhibitors (including anti-PD-1 or anti-PD-L1) before the first infusion of investigational product
12.For patients with hepatocellular carcinoma, their Child-Pugh score has to be A.
13.Able to be followed up as required by the study protocol.
Exclusion Criteria
1. Patients who still have persistent ≥ grade 2 toxicities from prior therapies.
2. Concurrent unstable or uncontrolled medical conditions. Either of the followings:
. Active systemic infections;
. Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg), or poor compliance with anti-hypertensive agents;
. 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;
. Uncontrolled diabetes or poor compliance with hypoglycemic agents;
. The presence of chronically unhealed wound or ulcers
. Other chronic diseases, which, in the opinion of the investigator, could compromise safety of the patient or the integrity of study.
3. 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.
4. 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).
5. Pregnancy (confirmed by serum beta human chorionic gonadotropin [ßHCG]) or breast-feeding.
6. Known history of human immunodeficiency virus infection (HIV).
7. Patient who has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroid (more than 10 mg per day) or immunosuppressive agents.
8. Patient who has active hepatitis B (HBsAg reactive) or hepatitis C (defined anti-HCV reactive)
9. Patient who has a history of interstitial lung disease
10. The patient is the investigator, sub-investigator or any one directly involved in the conduct of the study.
11. Patient has a history or current evidence of any condition or disease that could confound the results of the study, or is not the best interest of the patient to participate, in the opinion of Investigator.
2. Concurrent unstable or uncontrolled medical conditions. Either of the followings:
. Active systemic infections;
. Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg), or poor compliance with anti-hypertensive agents;
. 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;
. Uncontrolled diabetes or poor compliance with hypoglycemic agents;
. The presence of chronically unhealed wound or ulcers
. Other chronic diseases, which, in the opinion of the investigator, could compromise safety of the patient or the integrity of study.
3. 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.
4. 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).
5. Pregnancy (confirmed by serum beta human chorionic gonadotropin [ßHCG]) or breast-feeding.
6. Known history of human immunodeficiency virus infection (HIV).
7. Patient who has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroid (more than 10 mg per day) or immunosuppressive agents.
8. Patient who has active hepatitis B (HBsAg reactive) or hepatitis C (defined anti-HCV reactive)
9. Patient who has a history of interstitial lung disease
10. The patient is the investigator, sub-investigator or any one directly involved in the conduct of the study.
11. Patient has a history or current evidence of any condition or disease that could confound the results of the study, or is not the best interest of the patient to participate, in the opinion of Investigator.
The Estimated Number of Participants
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Taiwan
70 participants
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Global
0 participants
