Actively Recruiting
A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)
Led by Lyvgen Biopharma Holdings Limited · Updated on 2024-06-27
64
Participants Needed
17
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of LVGN6051 Combination Therapy in Patient With Head and Neck Squamous Cell Carcinoma (HNSCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able and willing to sign informed consent
- Histologically or cytologically confirmed recurrent/metastatic head and neck squamous cell carcinoma not resectable or curable by local treatment
- Disease progressed within 6 months after platinum-containing neoadjuvant, adjuvant, or curative chemoradiotherapy, or unsuitable for platinum-containing first-line systemic therapy
- Measurable lesions per RECIST 1.1 criteria
- ECOG performance status 0 or 1
- Life expectancy of at least 3 months
- Adequate organ function within 1 week before first dose, including hemoglobin, neutrophil and platelet counts, liver enzymes, coagulation tests, amylase, lipase, albumin, and creatinine clearance
- Negative pregnancy test for females of childbearing potential before first dose
- Male patients agree to use adequate contraception from first dose until 180 days after last dose
You will not qualify if you...
- Prior treatment targeting CD137 (4-1BB) or paclitaxel injection
- Candidates for curative-intent local treatment
- Received systemic anti-tumor therapy after recurrence or metastasis
- Not fully recovered from prior treatment-related adverse events within 2 weeks before first dose
- Within five half-lives of previous anticancer agents at first dose
- Risk of rapidly progressive disease, massive bleeding, airway obstruction, or uncontrolled tumor pain that may impair study compliance
- Immunodeficiency or recent systemic immunosuppressive treatment within 7 days before first dose (inhaled or low-dose corticosteroids allowed)
- Other malignancies within 5 years except certain cured skin and cervical or breast cancers
- Active central nervous system metastases or cancerous meningitis
- Active autoimmune disease requiring systemic treatment within past 2 years
- Prior allogeneic tissue/organ transplantation or cell therapy
- Active non-infectious pneumonia or interstitial lung disease needing glucocorticoids
- Active infection requiring IV antibiotics or unhealed wounds within 14 days before first dose
- Medical conditions or lab abnormalities that may interfere with study or safety
- Pregnant or nursing females or planning pregnancy during study
- Known HIV/AIDS diagnosis
- Active hepatitis B or C infection
- Live virus vaccine within 30 days before first dose
- Recent systemic immune-stimulating drugs within 4 weeks before first dose
- Significant heart or CNS disorders including recent heart attack, severe heart failure, unstable angina, uncontrolled arrhythmias, stroke, or brain hemorrhage
- Uncontrolled pleural, pericardial effusions, or ascites requiring repeated drainage
- History of severe allergies to study drug ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Anhui Cancer Hospital
Hefei, Anhui, China, 230000
Not Yet Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
3
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
4
Fujian cancer hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
5
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Not Yet Recruiting
6
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530021
Actively Recruiting
7
Henan cancer hospital
Zhengzhou, Henan, China, 450008
Not Yet Recruiting
8
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
9
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Not Yet Recruiting
10
Xiangya Hospital Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
11
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
Not Yet Recruiting
12
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
13
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
14
Liaoning cancer hospital
Shenyang, Liaoning, China, 110042
Not Yet Recruiting
15
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
16
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
17
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
Research Team
Y
Yan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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