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Evaluate Safety, Tolerability and Pharmacokinetics of HLX22 in Patients With Advanced Solid Tumors Overexpressing HER2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03916094
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : May 5, 2022
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Brief Summary:
a single-center, open-label, dose-escalation Phase I clinical trial to evaluate the safety and the tolerability of HLX22 in patients with advanced solid tumors overexpressing HER2 after failure of standard of care.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: HLX22 Phase 1

Detailed Description:

This study is an open-label and dose escalation study aimed at exploring the safety and MTD of HLX22.

three dose levels are designed for HLX22 in this study: 3, 10, and 25 mg/kg/3 weeks. The 3 mg/kg/3 weeks will serve as the starting dose. The study will use a 3+3 design to assign doses to the patients, and thereby determine the MTD of HLX22.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of HLX22 Monoclonal Antibody Injection (HER2 Monoclonal Antibody) in Patients With Advanced Solid Tumours Overexpressing HER2
Actual Study Start Date : July 31, 2019
Actual Primary Completion Date : January 4, 2021
Actual Study Completion Date : December 27, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: HLX22 group
HLX22, at four dose levels (3, 10, 25mg/kg), to be intravenously injected once every three weeks; Study drugs given until disease progression, one year of treatment, withdrawal from the study or death
Drug: HLX22
Humanized Anti-Human Epidermal Growth Factor Receptor-2 Monoclonal Antibody
Other Name: HER2 Monoclonal Antibody

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of HLX22 in patients with advanced solid tumors overexpressing HER2 [ Time Frame: from day1 to day 42(cycle 1 and cycle2 ,each cycle is 21days) ]
    The MTD is the dose with toxicity rate (estimated by isotonic regression) most approximate to the target one (30%).

Secondary Outcome Measures :
  1. the pharmacokinetic characteristics of HLX22 at different doses in patients. [ Time Frame: cycle1 to cycle 8 ,and 28-day follow-up visit after the last infusion (if possible),(each cycle is 21 days). ]
    Area under the plasma concentration versus time curve (AUC) for single dose and multiple doses

  2. the pharmacodynamic characteristics of HLX22 at different doses in patients [ Time Frame: cycle 1 to cycle 6 (each cycle is 21 days) ]
    the concentration of soluble HER1 and HER2 in serum

  3. the immunogenicity of HLX22 in humans [ Time Frame: cycle 1 to cycle 6 (each cycle is 21 days) ]
    anti-HLX22 antibodies in serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with child-bearing potential must agree to and be able to use effective contraceptive measures.

At least 28 days from prior major surgery, prior cytotoxic chemotherapy, prior hormonal therapy (except for androgen-deprivation therapy in patients with prostate cancer), prior therapy with investigational products (or medical device) or local radiotherapy, at least 42 days from prior chemotherapy with nitrosoureas or mitomycin C, and at least 42 days from prior immunotherapy before the first dose of HLX22.

At least one bi-dimensionally measurable lesion to be used as the basis for evaluation.

ECOG performance status of ≤ 1 at study entry. Patients with histologically-proven HER2-positive advanced or metastatic solid tumours who are either non-responsive or intolerant to standard therapies.

HER2-positive tumours that are confirmed by immunohistochemistry (IHC) and:

  1. HER2 mutation of at least 3+ (+++) or
  2. HER2 mutation of at least 2+ (++) and fluorescence in situ hybridization (FISH) test positive.

Adequate haematologic functions Adequate hepatic functions Adequate renal functions Adequate cardiac functions For patients with hepatocellular carcinoma, Child-Pugh score has to be A. Able to receive treatment and examinations as required by the study protocol. Life expectancy > 3 months. Exclusion Criteria Patients with history of alcohol or drug abuse, or positive for alcohol breath test before dosing.

Patients who still have ≥ Grade 2 toxicities from prior therapies (except for Grade 2 alopecia).

Concurrent unstable or uncontrolled medical conditions with either of the following:

  • Active systemic infections requiring intravenous antibiotic;
  • Poorly controlled hypertension, or poor compliance with anti-hypertensive agents;
  • Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (New York Heart Association [NYHA] Grade III or IV) or acute myocardial infarction within 6 months;
  • Uncontrolled diabetes mellitus or poor compliance with hypoglycemics;
  • NCI CTCAE Grade ≥ 2 hypercalcemia;
  • Presence of chronically unhealed wound or ulcers;
  • Other chronic diseases which, in the opinion of the Investigator, may compromise the safety of the patient or the integrity of the study.

Patients with history of interstitial lung disease. Patients with newly diagnosed or symptomatic brain metastases 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 can participate).

Patients have received a cumulative dose of doxorubicin (or equivalent) of ≥ 360 mg/m2.

Patients have participated in another clinical study within 4 weeks (in the case of a clinical study of a monoclonal antibody drug, 3 months or 5 half-lives, whichever is longer) prior to the enrolment, or patients have intended to participate in another clinical study during the period of the study.

Female patients in pregnancy (confirmed by ß-HCG test) or breastfeeding. Known history of human immunodeficiency virus (HIV) infection. Patients with active hepatitis B (positive for hepatitis B core antibody [HBcAb], or hepatitis B surface antigen [HBsAg], along with hepatitis B virus [HBV] DNA titre > the limit of normal defined by the study site), or hepatitis C (positive for hepatitis C antibody).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916094

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China, Jilin
First Hospital of Jilin University
Changchun, Jilin, China
Sponsors and Collaborators
Shanghai Henlius Biotech
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Principal Investigator: Yanhua Ding The First Hospital of Jilin University
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT03916094    
Other Study ID Numbers: HLX22-001
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Henlius Biotech:
overexpressing HER2
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents