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Solid Tumor and LymphomaPhase 1NCT05606380

A Phase I Study to Investigate the Safety, Tolerability and PK of HLX60 (Anti-GARP Monoclonal Antibody) in Subjects With Solid Tumors or Lymphoma

A Phase 1 study testing HLX60 in people with Solid Tumor and Lymphoma, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 trial is an open, dose escalation phase I clinical study. Subjects can only enter this study after they meet the inclusion and exclusion criteria.Into subjects will accept HLX60 intravenous infusion, every 3 weeks, treatment until lose clinical benefit, toxicity, death, revocation of informed consent. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor and Lymphoma
What is being tested?
HLX60
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
2 Dec 2022to Feb 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

  • Aged ≥ 18, ≤75 years at the time of signing the ICF;
  • Patients with histologically or cytologically confirmed advanced malignant solid tumor or lymphoma, who have failed or cannot receive the standard treatment;
  • With at least one evaluable lesion according to RECIST V1.1 (for solid tumors) or the Lugano criteria (for lymphomas);
  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at enrollment;
  • Expected survival > 3 months;
  • Have appropriate organ functions;
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  • The first administration of the investigational product must be: at least 28 days apart from the previous major surgery, medical device treatment, or local radiotherapy; at least 21 days apart from the previous cytotoxic chemotherapy, immunotherapy, and biological agent therapy; at least 14 days apart from the previous hormone therapy and surgical operation; at least 21 days or 5 half-lives apart from the administration of small molecule targeted drugs, whichever is longer; at least 14 days apart from the traditional Chinese medicine for tumor indications;
  • For patients with hepatocellular carcinoma, Child-Pugh score has to be A;
  • Male and female subjects with child-bearing potential must agree to use at least one highly effective contraception method during the study and within at least 6 months after the last administration of the investigational product.

Who cannot join

  • Have had other malignant tumors within 3 years before enrollment, except: (a) those with cured cervical carcinoma in situ or non-melanoma skin cancer; (b) those with cured second primary cancer without recurrence within 3 years; (c) those with double primary cancers believed to be able to benefit from this study; (d) those whose metastasis has been clearly excluded from a certain primary tumor source;
  • A history of (non-infectious) interstitial lung disease (ILD) requiring steroid use, current ILD, or a suspicion of ILD cannot be ruled out by imaging at screening; Note: Patients with radiation pneumonitis judged to be mild by the investigator can be enrolled.
  • The adverse reactions (except alopecia and other adverse reactions determined by the investigator to have no safety risk) of previous anti-tumor therapy have not yet recovered to ≤ grade 1 (CTCAE V5.0);
  • Those who are known to have severe anaphylaxis (grade 4 or greater in CTCAE V5.0) to macromolecular protein preparations/monoclonal antibodies or to any component of the investigational product;
  • Patients with any of the following unstable or poorly controlled diseases:1)Active systemic infectious diseases requiring intravenous antibiotics within 2 weeks before the first administration of the investigational product;2)Any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited (1) NYHA Class II or greater cardiac failure or left ventricular ejection fraction (LVEF) <50%;（2）unstable angina pectoris； (3) myocardial infarction and cerebral infarction within 6 months, (4) clinically significant supraventricular or ventricular arrhythmia without clinical intervention or poorly controlled after clinical intervention;3)Other chronic diseases which, in the opinion of the investigator, may compromise the safety of the patient or the integrity of the study;
  • Assessed as unsuitable for inclusion by the investigator, due to brain metastases, spinal cord compression, or cancerous meningitis with clinical symptoms, or uncontrolled brain or spinal cord metastases that have been evidenced; Note: Patients with asymptomatic or stable brain metastases, spinal cord compression, or carcinomatous meningitis as judged by the investigator were eligible for enrollment.
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  • Those who have received anti-GARP or anti-GARP/TGF-β antibody therapy;
  • Have active autoimmune diseases (including but not limited to the following diseases or syndromes, such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism), except: vitiligo or cured childhood asthma/allergy that does not need any intervention in adulthood, autoimmune mediated hypothyroidism treated with stable dose of thyroid replacement hormone, and type I diabetes treated with stable dose of insulin; those in a stable condition and requiring no systemic immunosuppressant therapy (including corticosteroid hormone) are allowed to be enrolled;
  • Have received systemic corticosteroids (prednisone > 10 mg/d or equivalent dose of similar drug) or other immunosuppressants within 14 days before the first administration; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; those with short term use of corticosteroids for prophylaxis, such as contrast agents;
  • Patients in pregnancy [confirmed by serum beta-human chorionic gonadotropin (ß-HCG) test] or breastfeeding;
  • With a history of immunodeficiency, including human immunodeficiency virus (HIV)-positive or other acquired or congenital immunodeficiencies, or a history of organ transplantation;
  • Have active tuberculosis。
  • Active HBV, HCV infection or co-infection;
  • Have received live vaccines within 28 days prior to the first administration;
  • Patients whose medical history or any other evidence suggests that participation in the study may confuse the results, or subjects for whom the investigator believes the study is not in their best interest.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First Affiliated Hospital, College of medicine, Zhejiang University

    Hangzhou

Other trials in China

About this study

Official title: A Phase I Clinical Study to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of HLX60 (Anti-GARP Monoclonal Antibody) in Subjects With Advanced/Metastatic Solid Tumors or Lymphoma

This trial is an open, dose escalation phase I clinical study. Subjects can only enter this study after they meet the inclusion and exclusion criteria.Into subjects will accept HLX60 intravenous infusion, every 3 weeks, treatment until lose clinical benefit, toxicity, death, revocation of informed consent.

Being tested
HLX60
Medical subject headings
Lymphoma

What participants receive

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

  • HLX60Drug

    HLX60(anti-GARP Monoclonal Antibody）have 5 dose cohorts: 0.5, 2, 5, 15, 25mg/kg, intravenous infusion, every 3 weeks.

Study groups in NCT05606380
Study groupRoleWhat they receive
HLX60 GroupExperimentalThe initial dose of HLX60 is 0.5mg/kg, and 5 dose levels are designed: 2mg/kg, 5mg/kg, 15mg/kg and 25mg/kg (Q3W). Patients will receive the treatment until without any clinical benefit, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first)
Receives: Drug: HLX60

What is being measured

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

  1. DLT

    The Dose-Limiting Toxicity (DLT) of HLX60 within 3 weeks after the first Administration in patients with Advanced/Metastatic Solid Tumors or Lymphomas

    Measured: from day1 to day 21

  2. MTD

    The Maximum Tolerated Dose (MTD) of HLX60 within 3 weeks after the first Administration in patients with Advanced/Metastatic Solid Tumors or Lymphomas

    Measured: from day1 to day 21

Timeline

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

  1. First posted4 Nov 2022
  2. Study start2 Dec 2022
  3. Primary completionAug 2024 (estimated)
  4. Study completionFeb 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
11 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05606380
Sponsor's protocol ID
HLX60-102
Status last verified
Aug 2023
First submitted
1 Nov 2022
Last updated
16 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX60 in people with Solid Tumor and Lymphoma, 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 9 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 16 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?

DLT (time frame: from day1 to day 21). The study lists 2 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 NCT05606380.

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 16 Apr 2024.

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