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Advanced Hepatocellular CarcinomaPhase 2NCT05290220

HLX07 Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma

A Phase 2 study testing HLX07, HLX10 and HLX04 in people with Advanced Hepatocellular Carcinoma, run by Shanghai Henlius Biotech.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is conducted in patients with advanced hepatocellular carcinoma (HCC). This study includes three arms: A, B, and C. Arm A will receive HLX07 combination therapy with HLX10 and HLX04 as first line treatment. Arm B will receive HLX07 combination therapy with lenvatinib as second line treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
HLX07, HLX10 and HLX04
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Aug 2022to 15 Dec 2024
Phase
Phase 2
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

  • Subjects who meet all of the following criteria are allowed to be enrolled into this study:
  • Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures.
  • Age ≥ 18 years and ≤ 75 years when ICF is signed.
  • Histopathologically or cytologically confirmed diagnosis of advanced hepatocellular carcinoma (HCC), Or the clinical diagnosis meets the american association for the study of liver diseases (AASLD) diagnostic criteria for HCC.
  • prior therapy: Arm A: Never received systemic anti-tumor drug therapy before. Arm B: Patient has a contraindication or intolerance to, or has failed treatment with 1-line systemic anti-tumor therapy (PD-1 /L1 -based combination therapies). Arm C: Previously received second or greater lines of systemic therapy. （Including： 1. PD-1/L1-based therapy 2. Lenvatinib or Sorafenib).
  • According to the curative effect evaluation criteria in solid tumors (RECIST) v1.1, assessed by the investigator with at least one measurable lesions. Measurable target lesions cannot be selected from the site of previous radiotherapy.
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  • (lesions located in the usual radiation area, if confirm progress, can also be selected as the target lesion).
  • Child-pugh liver function rating within 7 days before the first administration of the study drug : grade A and good grade B (≤ 7 points).
  • Arm B,C: The end of previous systematic treatment() must be ≥ 2 weeks before the first administration of the study drug, and the treatment-related AE should be restored to the level of NCI -CTCAE ≤ 1 (except hair loss).
  • The patient with HCC has liver surgery or local treatment (hepatic artery embolization, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) , Arm A and B : treatment was received ≥ 4 weeks prior to the first administration of this study. Arm C: treatment was received ≥ 2 weeks prior to the first administration of this study; The palliative radiotherapy for bone metastases was received ≥ 2 weeks prior to the first administration of this study; The diagnostic liver puncturewas received ≥ 1weeks prior to the first administration of this study. AEs related to previous local therapy should be recovered to the level of NCI -CTCAE ≤ 1.
  • The ECOG physical performance score within 7 days before the first administration of the study drug was 0 or 1.
  • Expected survival ≥ 12 weeks.
  • If HBsAg (+) or HBcAb (+), HBV-DNA must be<2500 copy/ml or ≤ 500 IU/mL or <ULN to be included in the group, and those with elevated HBV-DNA must agree to receive nucleoside anti-hepatitis b virus treatment. Subjects with negative HCV antibody (-) or HCV-RNA were admitted. If HCV-RNA is positive, must agree to receive standard of anti-virus treatment, and subjects must have ALT and AST ≤ 3×ULN to be enrolled. Subjects with co-infection of hepatitis b and c should be excluded.
  • The functions of the vital organs meet the following requirements (no blood transfusion, albumin, colony-stimulating factor, or platelet raising drugs are allowed within 14 days before the first use of the study drugs); Absolute neutrophil count (ANC) ≥1.5×109/L platelet≥ 100×109/L; Hemoglobin≥ 90g/ L; Serum albumin≥ 30g/L; Total bilirubin≤ 1.5 ULN, ALT, AST≤ 5 ULN(exclude the HCV-RNA is positive patients);Serum creatinine≤1.5 ULN or creatinine clearance > 50 mL/min (Cockcroft-Gault formula);APTT, INR and PT ≤1.5 ULN; Qualitative analysis of proteinuria≤1+; If ≥2+, 24-hour urine protein test is required, and the subject must have<1g to be enrolled.
  • For fertile female subjects, the serum pregnancy test must be negative within 7 days before the first dose.Subject agrees to use effective contraception.

Who cannot join

  • Subjects who meet any of the following criteria are not allowed to be enrolled in this study:
  • Hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma are known.
  • Hepatic encephalopathy within 6 months before the first administration of the study drug.
  • According to the images, portal vein invasion, inferior vena cava or cardiac involvement of HCC main portal branch (Vp4) were present. Patients with cancer thrombus in main portal vein but smooth blood flow in contralateral branch can be enrolled.
  • Other active malignancies within 3 years prior to the first administration of the study drug.Curable localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma in situ of the prostate, cervical carcinoma in situ, and carcinoma in situ of the breast, can be included in the group.
  • People who are ready to undergo or have received organ or bone marrow transplants.
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  • After appropriate intervention, uncontrollable pleural effusion, pericardial effusion or ascites still need to be drained frequently (once a month or more frequently).
  • Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
  • Cerebrovascular accident, Pulmonary embolism, deep vein thrombosis or any other serious thromboembolism, myocardial infarction, unstable angina pectoris and poorly controlled arrhythmia occurred within half a year (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women) (QTc interval was calculated by Fridericia formula).
  • According to the New York heart association (NYHA) standard levels Ⅲ or Ⅳ cardiac insufficiency or heart colour to exceed examination: LVEF(left ventricular ejection fraction) < 50%.
  • Human immunodeficiency virus (HIV) infection.
  • Active tuberculosis.Patients with previous and current cases of interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, and severe impairment of lung function that may interfere with the detection and management of suspected drug-related lung toxicity.
  • Within 14 days prior to the first administration of the study drug, any active infection requiring systematic anti-infective treatment occurs.
  • Major surgery was performed within 28 days prior to the first administration of the study drug. Major surgery in this study was defined as the minimum recovery time of 3 weeks after surgery before the surgery treated in this study could be performed.
  • Within 14 days prior to the first administration of the study drug, participating in other clinical studies.
  • Subjects requiring systemic treatment with corticosteroids (> 10 mg/ day or equivalent dose of prednisone) or other immunosuppressants within 14 days prior to or during the study.In the absence of active autoimmune disease, the inhalation or topical use of steroids, or adrenal hormone replacement at doses less than 10 mg/ day of prednisone efficacy, is permitted.
  • Patients who have previously received systemic anti-EGFR monoclonal antibody therapy.
  • History of severe hypersensitivity to any monoclonal antibody or study drug excipient.
  • Pregnant or lactating women.

Trial locations and contacts

No sites are listed yet.

Zhenggang Ren contact

13681971302

ren.zhenggang@zs-hospital.sh.cn

About this study

Official title: An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (A Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Motherapy in Patient With Advanced Hepatocellular Carcinoma (HCC)

This study is conducted in patients with advanced hepatocellular carcinoma (HCC). This study includes three arms: A, B, and C. Arm A will receive HLX07 combination therapy with HLX10 and HLX04 as first line treatment. Arm B will receive HLX07 combination therapy with lenvatinib as second line treatment. Arm C will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Being tested
HLX07, HLX10, HLX04, lenvatinib

What participants receive

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

  • HLX07Drug

    1500 mg

  • HLX10Drug

    300 mg

  • HLX04Drug

    15mg/kg

  • lenvatinibDrug

    12 mg (BW≥60 kg) or 8 mg (BW <60 kg)

Study groups in NCT05290220
Study groupRoleWhat they receive
Arm A: As first-line therapyExperimentalHLX07 1500 mg + HLX10 300 mg + HLX04 15mg/kg iv q3w
Receives: Drug: HLX07; Drug: HLX10; Drug: HLX04
Arm B: As second-line therapyExperimentalHLX07 1500 mg iv Q3w + Lenvatinib 12 mg (BW≥60 kg) or 8 mg (BW <60 kg) po qd
Receives: Drug: HLX07; Drug: lenvatinib
Arm C:As third-line or above therapyExperimentalHLX07 1500 mg iv Q3w
Receives: Drug: HLX07

What is being measured

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

  1. ORR

    Objective response rate by INV assessment per RECIST

    Measured: up to 2 years

  2. PFS

    Progression-free survival by INV assessment per RECIST

    Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years

Secondary outcomes (2)

  1. OS

    Overall survival

    Measured: from the date of first dose unitl the date of death from any cause, assessed up to 2 years

  2. DOR

    Duration of response

    Measured: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),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 posted22 Mar 2022
  2. Study start1 Aug 2022 (estimated)
  3. Primary completion15 Dec 2023 (estimated)
  4. Study completion15 Dec 2024 (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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05290220
Sponsor's protocol ID
HLX07-HCC201
Status last verified
Mar 2022
First submitted
7 Mar 2022
Last updated
3 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HLX07, HLX10 and HLX04 in people with Advanced Hepatocellular Carcinoma, run by Shanghai Henlius Biotech.

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 15 inclusion and 19 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Zhenggang Ren (13681971302, ren.zhenggang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: up to 2 years). 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 NCT05290220.

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 3 May 2022.

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