A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)
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
1 other identifier
interventional
64
1 country
17
Brief 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, curative, or adjuvant platinum-containing therapy, or who are currently contraindicated for platinum-containing treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2024
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2024
CompletedFirst Posted
Study publicly available on registry
April 22, 2024
CompletedStudy Start
First participant enrolled
June 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2027
June 27, 2024
April 1, 2024
3.4 years
April 12, 2024
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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)
6 months
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)
through study completion, an average of 30 months
Study Arms (1)
LVGN6051combined with toripalimab and paclitaxel
EXPERIMENTALLVGN6051 in combination with toripalimab and paclitaxel
Interventions
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 Injection: 240mg fixed dose,Q3W, on the first day of the treatment cycle for up to 2 years.
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
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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).
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Anhui Cancer Hospital
Hefei, Anhui, 230000, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100730, China
Fujian cancer hospital
Fuzhou, Fujian, 350014, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Henan cancer hospital
Zhengzhou, Henan, 450008, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Liaoning cancer hospital
Shenyang, Liaoning, 110042, China
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, 200123, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ye Guo
Shanghai Oriental Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2024
First Posted
April 22, 2024
Study Start
June 21, 2024
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
October 31, 2027
Last Updated
June 27, 2024
Record last verified: 2024-04