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Advanced/Metastatic Solid TumorsPhase 1NCT05394168

A Phase I Clinical Study of HLX53 in Advanced/Metastatic Solid Tumors

A Phase 1 study testing HLX53 in people with Advanced/Metastatic Solid Tumors, run by Shanghai Henlius Biotech at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This phase I, first-in-human, open-label clinical study will evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HLX53 (an anti-TIGIT Fc fusion protein) in patients with advanced/metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced/Metastatic Solid Tumors
What is being tested?
HLX53
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
9 Dec 2022to 4 Mar 2025
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

  • Voluntary participation in clinical studies, full understanding of the trial, and signing of informed consent, willingness to follow and ability to complete the study in accordance with the requirements of the trial protocol.
  • histologically or cytologically confirmed advanced/metastatic solid tumors or lymphoma, failure of standard therapy, or no standard therapy.
  • Age ≥ 18 years and ≤ 75 years at the time of informed consent.
  • Eastern Cooperative Oncology Group (ECOG) score 0 or 1.
  • At least one measurable lesion according to RECISTv1.1 or 2014 Lugano (lymphoma) response evaluation criteria.
  • Life expectancy of more than three months.
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  • Adequate hematological function.
  • Adequate liver function.
  • Adequate renal function
  • Adequate cardiac function.
  • Male and female subjects of childbearing potential must agree to use at least 1 highly effective method of contraception during the trial and for at least 6 months after the last dose of study drug.

Who cannot join

  • Known history of serious allergy to the components of HLX53 or to any monoclonal antibody.
  • Prior treatment with anti-TIGIT or antibody to the relevant target CD155, CD112, or CD113.
  • Unresolved toxicity after prior antineoplastic therapy, i.e., not resolved to baseline, Grade 0-1 per NCI-CTCAE 5.0 (except alopecia).
  • Coexisting unstable or controlled medical conditions.
  • Spinal cord compression with clinical symptoms.
  • Prior allogeneic bone marrow transplant or solid organ transplant.
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  • History of primary immunodeficiency.
  • History of eczema or asthma that cannot be controlled by topical corticosteroids.
  • History of any second malignancy within 2 years, except for curatively treated early malignancies (carcinoma in situ or stage I tumors) such as non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, ductal carcinoma in situ of the breast, papillary thyroid cancer.
  • Vaccination with a live attenuated vaccine within 4 weeks prior to the first dos.e
  • Use of immunosuppressive drugs within 2 weeks prior to initial administration.
  • Received major surgery, anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy or biological therapy) within 4 weeks prior to the first dose.
  • Known to have active infectious disease such as active HBV, HCV infection.
  • History of human immunodeficiency virus (HIV) infection.
  • Pregnancy or lactation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX53 (an Anti-TIGIT Fc Fusion Protein) in Patients With Advanced/Metastatic Solid Tumors

This phase I, first-in-human, open-label clinical study will evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HLX53 (an anti-TIGIT Fc fusion protein) in patients with advanced/metastatic solid tumors.

Read the detailed description

This study is an open-label phase I clinical study to evaluate the safety, tolerability , PK/PD and preliminary efficacy of HLX53 in patients with advanced/metastatic solid tumor. 11-30 subjects with advanced or metastatic solid tumors will be enrolled. The accelerated titration and traditional 3 + 3 dose escalation design will be implemented. Subjects will receive intravenous infusion of HLX53 at different doses according to the order of enrollment. There are 5 preset dose groups, namely 30mg/QW, 150mg/QW, 400mg/QW, 1000mg/Q3W and 2000mg/Q3W, administered by intravenous infusion. Observation period of DLT will last for 21 days after the first administration of HLX53. Maximum tolerated dose (MTD) definition: The highest dose level at which no more than 1 of 6 DLT-evaluable subjects developed DLT. At the MTD dose, at least 6 subjects were evaluable for DLT. When the MTD is determined, the MTD is usually used as the RP2D, or the RP2D is determined based on safety, PK/PD/ADA/NAb characteristics, and potential clinical efficacy.

Being tested
HLX53

What participants receive

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

  • HLX53Biological

    There are 5 preset dose groups, namely 30mg/QW, 150mg/QW, 400mg/QW, 1000mg/Q3W and 2000mg/Q3W, administered by intravenous infusion.

Study groups in NCT05394168
Study groupRoleWhat they receive
HLX53Experimentalan anti-TIGIT Fc fusion protein
Receives: Biological: HLX53

What is being measured

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

  1. Adverse event

    Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 for patients receiving study drug.

    Measured: Through study completion, assessed up to 2 years.

  2. Incidence of DLT

    Ratio of the number of patients with DLT events in each dose group to the number of patients in the dose group during the DLT evaluation period.

    Measured: Up to 3 weeks.

  3. MTD

    The maximum tolerated dose (MTD) of HLX53

    Measured: Up to 3 weeks

  4. RP2D

    The recommended phase II dose (RP2D) of HLX53

    Measured: Through study completion, assessed up to 2 years.

Secondary outcomes (8)

  1. Cmax

    Peak concentration of HLX53

    Measured: From baseline to 30 days after the last administration, assessed up to 7 months

  2. Tmax

    Time to reach peak concentration of HLX53

    Measured: From baseline to 30 days after the last administration, assessed up to 7 months

  3. t1/2

    Elimination half-life of HLX53

    Measured: From baseline to 30 days after the last administration, assessed up to 7 months

  4. TIGIT Receptor Occupancy

    TIGIT Receptor Occupancy of HLX53 on Peripheral Circulating T Cells

    Measured: From baseline to 30 days after the last administration，assessed up to 7 months

  5. ADA

    Incidence of anti-drug antibodies (ADA)

    Measured: From baseline to 30 days after the last administration，assessed up to 7 months

  6. Objective response rate (ORR)

    Percentage of patients with complete response or partial response determined by investigators according to RECIST v1.1, iRECIST 2017 (solid tumors), or Lugano 2014 (lymphoma).

    Measured: Through study completion, assessed up to 2 years.

  7. Progression-free survival (PFS)

    PFS is defined as the time from the first administration of HLX53 to the first occurrence of disease progression or death due to any cause, whichever occurs first.

    Measured: From date of the first HLX53 administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.

  8. Overall survival(OS)

    OS is defined as the time from the first administration of HLX53 to death due to any cause.

    Measured: From date of the first HLX53 administration until the date of death from any cause, whichever came first, assessed up to 2 years.

Timeline

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

  1. First posted27 May 2022
  2. Study start9 Dec 2022
  3. Primary completion4 Dec 2024 (estimated)
  4. Study completion4 Mar 2025 (estimated)

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05394168
Sponsor's protocol ID
HLX53-FIH101
Status last verified
Mar 2024
First submitted
29 Apr 2022
Last updated
1 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX53 in people with Advanced/Metastatic Solid Tumors, 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 11 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. 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?

Results are not available in the source record.

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?

Adverse event (time frame: Through study completion, assessed up to 2 years.). The study lists 4 primary outcomes in all. 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 NCT05394168.

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 1 Apr 2024.

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