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Head and Neck Squamous Cell CarcinomaPhase 2NCT06378177

A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)

A Phase 2 study testing LVGN6051 Monoclonal Antibody Injection, toripalimab Injection and Paclitaxel injection in people with Head and Neck Squamous Cell Carcinoma, run by Lyvgen Biopharma Holdings Limited at 16 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to assess the safety and efficacy of LVGN6051 (4-1BB agonistic antibody) combined with toripalimab (anti-PD-1 antibody) and paclitaxel (anti-tubulin chemotherapy) in patients with recurrent/metastatic head and neck squamous cell carcinoma who rapidly progress from previous neoadjuvant… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
LVGN6051 Monoclonal Antibody Injection, toripalimab Injection and Paclitaxel injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
16 sitesChina
Study dates
21 Jun 2024to 31 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of 18 years or older on the date of signing the informed consent.
  • Understand and be willing to sign a written informed consent.
  • Patients with recurrent/metastatic head and neck squamous cell carcinoma confirmed by histology or cytology (the primary tumor is located in the oral cavity, oropharynx, hypopharynx, or larynx) that cannot be resected and cannot be cured by local treatment.
  • The status of head and neck squamous cell carcinoma meets one of the following requirements: a. There is still residual tumor, local recurrence, or metastatic cancer within 6 months after platinum-containing neoadjuvant treatment, adjuvant treatment, or curative concurrent chemoradiotherapy, or b. Any residual tumor, local recurrence, or metastatic cancer should receive first-line systemic therapy, but this first-line systemic therapy is not suitable for platinum-containing regimens.
  • Have measurable lesions as defined by the RECIST 1.1.
  • ECOG PS 0 or 1.
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  • Life expectancy estimated at ≥3 months.
  • The functions of important organs within 1 week before the first dose meet all the following requirements: a. Hb ≥9.0 g/dL (90 g/L), b. ANC ≥1500/μL (1.5×109/L), c. Platelet count (PLT) ≥100,000/μL (100×109/L), d. Total bilirubin ≤ upper limit of normal laboratory value (ULN), e. AST ≤1.5× ULN and ALT ≤1.5× ULN, f. International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤1.5× ULN, g. Serum amylase and lipase ≤1.5× ULN, h. serum albumin ≥3.0 g/dL (30 g/L), and i. CCR ≥30 ml/min.
  • Female patients of childbearing potential should have a negative blood pregnancy test or urine pregnancy test within 72 hours before the first dose of study treatment.
  • Male patients should agree to take adequate contraceptive measures from the first dose of study treatment to 180 days after the last dose.

Who cannot join

  • Have received drug treatment targeting CD137 (4-1BB) or paclitaxel injection.
  • Subjects who are suitable to receive curative-intent local treatment.
  • Have received any systemic anti-tumor treatment after disease recurrence or metastasis.
  • Failed to fully recover from the adverse events caused by the previous anti-tumor treatment within 2 weeks before receiving the first dose of study treatment (i.e., ≤ grade 1 or baseline).
  • At the first dose of study treatment, it is still within 5 half-lives of previous anti-cancer agents.
  • Have risk of rapidly progressive disease, immediate risk of massive bleeding, airway obstruction, or uncontrolled significant tumor pain that, in the opinion of the investigator, may impair compliance with study treatment.
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  • Diagnosed with immunodeficiency or receiving systemic steroids or any other immunosuppressive treatments within 7 days before the first dose of study treatment. The use of inhaled, topical, or physiologic doses of corticosteroids is allowed, i.e., ≤10 mg/day of prednisone or equivalent.
  • Have other malignant tumors diagnosed and/or treated within 5 years before the first dose of study treatment, except for cured basal cell carcinoma of the skin, cured squamous cell carcinoma of the skin, resected uterine cervical carcinoma in situ, resected breast cancer in situ. Other exceptions can be discussed with the sponsor.
  • Known occurrence of active central nervous system (CNS) metastases and/or cancerous meningitis.
  • Have an active autoimmune disease that has required systemic treatment, such as disease-modifying agents, corticosteroids, or immunosuppressive drugs in the past 2 years. Replacement therapies (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for hypothyroidism, adrenal insufficiency, pituitary insufficiency, etc.) are not considered systemic treatments.
  • Have previously received allogeneic tissue/organ transplantation or any cell therapy.
  • Currently suffering from active, non-infectious pneumonia or interstitial lung disease that requires treatment with oral or intravenous glucocorticoids.
  • Active infection requiring intravenous (IV) anti-infective drugs within the first 14 days before the first dose of study treatment or the presence of unhealed wounds or ulcers.
  • The investigator believes that any previous or existing medical condition, treatment, or laboratory test abnormality may affect the study results, interfere with the patient's participation in the entire study, or the study participation is not in the patient's best interest.
  • Female patients who are pregnant or nursing or who plan to become pregnant or give birth during the study period (i.e., from the beginning of the screening period to 180 days after the last treatment).
  • Patients known to have tested positive for human immunodeficiency virus (HIV) or known to have acquired immunodeficiency syndrome (AIDS).
  • Known to have active hepatitis B or hepatitis C.
  • Have received live virus vaccine within 30 days before the first dose of study treatment.
  • Have received systemic immune-stimulating drugs (e.g., IL-2, IFN-γ) within 4 weeks before the first dose of study treatment.
  • Clinically significant heart and CNS disorders, including acute myocardial infarction within 6 months before Cycle 1 Day 1, congestive heart failure as Class III or IV by the New York Heart Association, unstable angina, uncontrolled arrhythmias requiring further treatment, stroke, or brain hemorrhage. Subjects with arrhythmia who are treated with antiarrhythmic drugs and whose electrocardiogram (ECG) screening shows a controlled heart rhythm may be enrolled.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Patients with a history of severe allergies may be allergic to the ingredients of the investigational drugs.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Tongren Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100730

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan, 410011

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian cancer hospital

    Fuzhou, Fujian, 350014

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Anhui Cancer Hospital

    Hefei, Anhui, 230000

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

  • Shanghai Oriental Hospital

    Shanghai, Shanghai Municipality, 200123

  • Liaoning cancer hospital

    Shenyang, Liaoning, 110042

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • Henan cancer hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

Official title: A Phase 2 Study of LVGN6051 Combined With Toripalimab and Paclitaxel for Recurrent/Metastatic HNSCC Rapidly Progressed From Previous Platinum-containing Curative Treatment or Contraindicated for Platinum-containing Treatment

The purpose of this study is to assess the safety and efficacy of LVGN6051 (4-1BB agonistic antibody) combined with toripalimab (anti-PD-1 antibody) and paclitaxel (anti-tubulin chemotherapy) in patients with recurrent/metastatic head and neck squamous cell carcinoma who rapidly progress from previous neoadjuvant, curative, or adjuvant platinum-containing therapy, or who are currently contraindicated for platinum-containing treatment.

Read the detailed description

This is a multicenter, open-labeled, single-arm Phase 2 clinical study to evaluate the safety and efficacy of LVGN6051 in combination with toripalimab and paclitaxel in selected patients with recurrent/metastatic head and neck squamous cell carcinoma under the guidance of Good Clinical Practise(GCP).

This study comprises two parts. Part 1 (Safety run-in Phase) is designed to confirm the dose of combination therapy in Part 2. Part 1 includes a "3+3 dose-escalation design" for 2 dose levels, i.e., LVGN6051 1 mg/kg or LVGN6051 2 mg/kg with standard doses of toripalimab and paclitaxel (every 3 weeks for a treatment cycle). Part 1 will treat up to 12 DLT-evaluable patients, and the Data monitoring committee(DMC), based on the safety profile, will confirm the recommended dose for combination therapy in Part 2.

Part 2 (Efficacy Exploration Phase) will treat up to 52 patients with evaluable tumor response (efficacy) using the recommended dose of combination therapy determined in Part 1. The sample size for Part 2 is based on Simon's two-stage minimax design, which uses the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) objective response rate (ORR) as the primary efficacy endpoint. The first stage will include 28 patients with evaluable tumor response (efficacy). If 6 or more responses are observed, the second stage 2 will consist of an additional 24 patients with evaluable tumor response. Part 1 patients with the same dose level as Part 2, if they meet evaluable tumor response, can be included in the required 52 patients with evaluable tumor response.

Being tested
LVGN6051 Monoclonal Antibody Injection, toripalimab Injection, Paclitaxel injection
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • LVGN6051 Monoclonal Antibody InjectionBiological

    Also called LVGN6051

    LVGN6051 Monoclonal Antibody Injection:1 mg/kg or 2 mg/kg, every 3 weeks(Q3W) , on the first day of the treatment cycle for up to 2 years.

  • toripalimab InjectionBiological

    toripalimab Injection: 240mg fixed dose,Q3W, on the first day of the treatment cycle for up to 2 years.

  • Paclitaxel injectionDrug

    paclitaxel Injection:5ml:100 mg/m2(80 mg/m2 or 60 mg/m2 can be used if necessary),Q3W,on the first and eighth day of the treatment cycle for up to 2 years

Study groups in NCT06378177
Study groupRoleWhat they receive
LVGN6051combined with toripalimab and paclitaxelExperimentalLVGN6051 in combination with toripalimab and paclitaxel
Receives: Biological: LVGN6051 Monoclonal Antibody Injection; Biological: toripalimab Injection; Drug: Paclitaxel injection

What is being measured

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

  1. to determine treatment-related adverse events (TRAEs, the safety and tolerability of two preset dose levels )

    The safety and tolerability of two preset dose levels based on treatment-related adverse events (TRAEs), including dose-limiting toxicities(DLTs )and serious adverse events (SAEs), through a "safety run-in" to determine the Part 2 therapeutic dose of LVGN6051 in combination with toripalimab and paclitaxel. (Part 1)

    Measured: 6 months

  2. to determine objective response rate (ORR)

    The anti-tumor activity of LVGN6051 combined with toripalimab and paclitaxel will be evaluated by independent central review (ICR) according to RECIST 1.1 for objective response rate (ORR). (Part 2)

    Measured: through study completion, an average of 30 months

Timeline

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

  1. First posted22 Apr 2024
  2. Study start21 Jun 2024
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (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
Not applicable
Intervention model
Sequential
Model description
This is a multicenter, open-labeled, single-arm Phase 2 clinical study.This study comprises two parts. Part 1 (Safety Run-in Phase) is designed to confirm the dose of combination therapy in Part 2.
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06378177
Sponsor's protocol ID
LVGN6051-0402-HNSCC
Status last verified
May 2026
First submitted
12 Apr 2024
Last updated
19 May 2026
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 LVGN6051 Monoclonal Antibody Injection, toripalimab Injection and Paclitaxel injection in people with Head and Neck Squamous Cell Carcinoma, run by Lyvgen Biopharma Holdings Limited at 16 sites 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 10 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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 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?

This study is still under way. Results are not available in the source record yet.

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?

to determine treatment-related adverse events (TRAEs, the safety and tolerability of two preset dose levels ) (time frame: 6 months). 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 NCT06378177.

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 19 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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