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

NCT03916094 | Completed Phase 1

• 1 other identifier: HLX22-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Keywords

overexpressing HER2

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of HLX22 in patients with advanced solid tumors overexpressing HER2

  The MTD is the dose with toxicity rate (estimated by isotonic regression) most approximate to the target one (30%).

  from day1 to day 42(cycle 1 and cycle2 ,each cycle is 21days)

Secondary Outcomes (3)

• the pharmacokinetic characteristics of HLX22 at different doses in patients.

  cycle1 to cycle 8 ,and 28-day follow-up visit after the last infusion (if possible),(each cycle is 21 days).

• the pharmacodynamic characteristics of HLX22 at different doses in patients

  cycle 1 to cycle 6 (each cycle is 21 days)

• the immunogenicity of HLX22 in humans

  cycle 1 to cycle 6 (each cycle is 21 days)

Study Arms (1)

HLX22 group

EXPERIMENTAL

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

Interventions

HLX22 DRUG

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

Also known as: HER2 Monoclonal Antibody

HLX22 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, China

Location

Related Publications (1)

• Zhu X, Ding Y, Wang Q, Yang G, Zhou L, Wang Q. HLX22, an anti-HER-2 monoclonal antibody, in patients with advanced solid tumors overexpressing human epidermal growth factor receptor 2: an open-label, dose-escalation, phase 1 trial. Invest New Drugs. 2023 Jun;41(3):473-482. doi: 10.1007/s10637-023-01338-7. Epub 2023 May 4.

  PMID: 37140695 DERIVED

MeSH Terms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yanhua Ding

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 16, 2019
• Study Start: July 31, 2019
• Primary Completion: January 4, 2021
• Study Completion: December 27, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)