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

NCT ID: NCT03916094

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2021-12-27

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.

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

HLX22

Intervention Type: DRUG

Humanized Anti-Human Epidermal Growth Factor Receptor-2 Monoclonal Antibody

Interventions

HLX22

Humanized Anti-Human Epidermal Growth Factor Receptor-2 Monoclonal Antibody

Intervention Type: DRUG

Other Intervention Names

HER2 Monoclonal Antibody

Eligibility Criteria

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.

Exclusion Criteria

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).

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

HLX22-001

Identifier Type: -

Identifier Source: org_study_id