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Solid TumorPhase 1NCT03916094

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

A Phase 1 study testing HLX22 in people with Solid Tumor, run by Shanghai Henlius Biotech at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
HLX22
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteChina
Study dates
31 Jul 2019to 27 Dec 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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).
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Hospital of Jilin University

    Changchun, Jilin

Other trials in China

About this study

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

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.

Read the 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
Being tested
HLX22
Keywords
overexpressing HER2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLX22Drug

    Also called HER2 Monoclonal Antibody

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

Study groups in NCT03916094
Study groupRoleWhat they receive
HLX22 groupExperimentalHLX22, 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
Receives: Drug: HLX22

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%).

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

Secondary outcomes (3)

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

    Area under the plasma concentration versus time curve (AUC) for single dose and multiple doses

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

  2. the pharmacodynamic characteristics of HLX22 at different doses in patients

    the concentration of soluble HER1 and HER2 in serum

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

  3. the immunogenicity of HLX22 in humans

    anti-HLX22 antibodies in serum

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start31 Jul 2019
  3. Primary completion4 Jan 2021
  4. Study completion27 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03916094
Sponsor's protocol ID
HLX22-001
Status last verified
Apr 2022
First submitted
4 Apr 2019
Last updated
5 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37140695

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX22 in people with Solid Tumor, run by Shanghai Henlius Biotech at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03916094, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.

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