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Adult Solid TumorPhase 1NCT05400265

Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HLX26 and HLX10 in Patients With Advanced/Metastatic Solid Tumor

A Phase 1 study testing HLX26 and HLX10 in people with Adult 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

This study is a open-label, phase I, dose escalation clinical study to evaluate the safety and tolerability of HLX26 and HLX10 in the treatment of 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
Adult Solid Tumor
What is being tested?
HLX26 and HLX10
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
26 Jul 2022to 31 Jan 2024
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

  • Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
  • Aged ≥ 18 years and ≤75 years at the time of signing the ICF;
  • Patients with histologically or cytologically confirmed advanced malignant solid tumor who have failed or cannot receive the standard treatment;
  • With at least one measurable lesion according to RECIST V1.1 (for solid tumors);
  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at enrollment;
  • Expected survival > 3 months;
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  • Patients with Non-Small Cell Lung Cancer had no EGFR sensitivity mutation or gene rearrangement or jump of ALK, ROS1, RET and METex14;
  • For patients with hepatocellular carcinoma, Child-Pugh score has to be A;
  • Have appropriate hematological functions: no blood transfusion or Treatment for hemocytopenia within 14 days before the first administration; absolute neutrophil count ≥ 1500/μL; haemoglobin ≥ 9 g/dL; platelet count ≥ 90,000/μL;
  • Have appropriate coagulation functions: activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; prothrombin time (PT) ≤ 1.5 × ULN; international normalized ratio (INR) ≤ 1.5 × ULN;
  • Have appropriate liver functions: total bilirubin level ≤ 1.5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN (AST and ALT ≤ 5 × ULN for patients with known liver metastasis or primary hepatocellular carcinoma);
  • Have appropriate renal functions: blood creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (calculated by Cockcroft-Gault formula);
  • 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 28 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; at least 14 days apart from the endocrine therapy; For any drug with antitumor effect not listed above, at least 5 half lives shall be separated before administration of the first study drug;
  • 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

  • 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 to: (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;
  • Previous grade 3 or greater irAEs in immunotherapy;
  • Have had other malignant tumors within 5 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 5 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;
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  • those who have received anti-LAG-3 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;
  • Patients with active HBV or HCV infection (HBV DNA ≥ 10*4 copies/mL or positive HCV RNA, but patients with HBV DNA < 10*4 copies / mL after treatment will be excluded); Subjects with co-infection of hepatitis B and hepatitis C (HBsAg or HBcAb positive, and HCV antibody positive);
  • Have received live vaccines within 28 days prior to the first administration;
  • Interstitial pneumonia occurred during previous anti-tumor treatment;
  • 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;
  • Participating in other clinical studies or less than 14 days from the end of the treatment of the previous clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu

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 HLX26 Monoclonal Antibody Injection in Combination With HLX10 Monoclonal Antibody Injection in Patients With Advanced/Metastatic Solid Tumor

This study is a open-label, phase I, dose escalation clinical study to evaluate the safety and tolerability of HLX26 and HLX10 in the treatment of patients with advanced/metastatic solid tumors.

Read the detailed description

This study is a open-label, phase I, dose escalation clinical study to evaluate the safety and tolerability of HLX26 and HLX10 in the treatment of patients with advanced/metastatic solid tumors. In this study, a 3 + 3 dose escalation design was used. The patients will be given different doses(500mg, 800mg Q3W) of HLX26 Plus fixed dose of HLX10(300mg) intravenously. Observation period of DLT lasts for 3 weeks after the first administration of HLX26.

Being tested
HLX26, HLX10
Keywords
LAG-3

What participants receive

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

  • HLX26Drug

    Also called Anti-LAG-3 Monoclonal Antibody

    Humanized Anti-Lymphocyte Activation Gene-3 Monoclonal Antibody

  • HLX10Drug

    Also called Anti-PD-1 Humanized Monoclonal Antibody, SERPLULIMAB

    Humanized Anti-Programmed Death-1 Monoclonal Antibody

Study groups in NCT05400265
Study groupRoleWhat they receive
Dose Cohort 1ExperimentalIn this cohort, the dose of HLX26 is 500mg. HLX26 will be intravenously administered every 3 weeks. HLX10 will be intravenously administered every 3 weeks with the fixed dose of 300mg. Patients will receive the treatment until they have been in therapy for 2 years, develop progressive disease (PD) without any clinical benefit, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first).
Receives: Drug: HLX26; Drug: HLX10
Dose Cohort 2ExperimentalIn this cohort, the dose of HLX26 is 800mg. HLX26 will be intravenously administered every 3 weeks. HLX10 will be intravenously administered every 3 weeks with the fixed dose of 300mg. Patients will receive the treatment until they have been in therapy for 2 years, develop progressive disease (PD) without any clinical benefit, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first).
Receives: Drug: HLX26; Drug: HLX10
Dose Cohort 3ExperimentalIn this cohort, the dose of HLX26 is 1600mg. HLX26 will be intravenously administered every 3 weeks. HLX10 will be intravenously administered every 3 weeks with the fixed dose of 300mg. Patients will receive the treatment until they have been in therapy for 2 years, develop progressive disease (PD) without any clinical benefit, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first).
Receives: Drug: HLX26; Drug: HLX10

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 HLX26 in combination with HLX10 within 3 weeks after the first Administration in patients with Advanced/Metastatic Solid Tumors

    Measured: from day1 to day 21

  2. MTD

    The Maximum Tolerated Dose (MTD) of HLX26 in combination with HLX10 within 3 weeks after the first Administration in patients with Advanced/Metastatic Solid

    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 posted1 Jun 2022
  2. Study start26 Jul 2022
  3. Primary completion31 Aug 2023
  4. Study completion31 Jan 2024

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05400265
Sponsor's protocol ID
HLX26-002
Status last verified
Feb 2024
First submitted
23 May 2022
Last updated
6 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liu R, Jing H, Chen Y, Gao S, Zhang J, Cao X, Li K, Liu Y, Meng M, Chen C, Sun C, Yu H, Wang Q, Li J, Wu Y, Zhang J. Phase I Studies of HLX26, A Novel Anti-LAG-3 Antibody, Monotherapy or Combination Therapy in Patients with Advanced Solid Tumors. BioDrugs. 2026 Mar;40(2):335-348. doi: 10.1007/s40259-025-00751-z. Epub 2026 Jan 15.

    PubMed 41538111

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLX26 and HLX10 in people with Adult 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 14 inclusion and 16 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 6 Feb 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?

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?

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 NCT05400265, 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 6 Feb 2024.

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