Actively Recruiting
A Study of LVGN6051 Combined with Anlotinib in Patient with Soft Tissue Sarcoma
Led by Lyvgen Biopharma Holdings Limited · Updated on 2024-10-15
65
Participants Needed
5
Research Sites
177 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to asess the safety and tolerability and efficacy of LVGN6051 combined with anlotinib in patient with soft tissue sarcoma.
CONDITIONS
Official Title
A Study of LVGN6051 Combined with Anlotinib in Patient with Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 70 years with unresectable locally advanced, metastatic, or recurrent refractory soft tissue sarcoma confirmed by pathology
- Ability to understand and sign written informed consent
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Estimated life expectancy of at least 90 days
- Adequate bone marrow function: hemoglobin 90 g/L, neutrophil count 1.5x10^9/L, platelet count 75x10^9/L
- Adequate liver function: total bilirubin 1.5 times upper limit of normal (ULN) or 2.5 times ULN if Gilbert's syndrome, AST and ALT 1.5 times ULN, normal coagulation tests within therapeutic range if on anticoagulants, amylase and lipase 1.5 times ULN
- Adequate renal function: estimated creatinine clearance 50 mL/min or serum creatinine 1.5 times ULN
- Women of childbearing potential must agree to use effective contraception or abstain during and for 120 days after treatment
- Men must agree to abstain, be surgically sterilized, or use contraception during and for 120 days after treatment
- Recovery to baseline or mild grade (0-1) of previous anticancer therapy side effects except some allowed exceptions within 14 days prior to treatment
- At least one measurable tumor lesion by RECIST v1.1
- Prior treatment with at least one line of approved chemotherapy including anthracycline except for acinar and clear cell sarcoma under specific conditions
You will not qualify if you...
- Prior anti-CD137 therapy
- Systemic anticancer therapy within 5 half-lives or 28 days before study
- Radiotherapy within 14 days (28 days for CNS) before study
- Unstable brain metastases or carcinomatous meningitis
- Live-virus vaccine within 30 days before study
- Severe allergic reactions to monoclonal antibodies or hypersensitivity to study drugs
- QTcF interval over 480 ms or congenital prolonged QT syndrome
- History of severe immune-related adverse events except some controlled exceptions
- Immunological treatments or systemic steroids over 10 mg prednisone equivalent within 7 days before study
- Immune-stimulatory agents within 4 weeks before study
- Active or recent autoimmune disease requiring systemic treatment
- Significant cardiac conditions or arrhythmias requiring therapy
- Uncontrolled pleural, pericardial effusions, or recurrent ascites
- Active infections requiring IV antibiotics or nonhealing wounds
- Interstitial lung disease or active pneumonitis needing treatment
- Pregnant or breastfeeding women
- Severe uncontrolled systemic diseases
- Known HIV, active hepatitis B or C infections
- Serious medical or psychiatric conditions affecting safety or study integrity
- Prior organ, stem cell, or bone marrow transplants
- Previous cell therapies including CAR T-cell therapy
- Use of traditional Chinese medicine with anticancer ingredients within 30 days
- Other malignancies within 5 years except certain early-stage cured cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Henan cancer hospital
Zhenzhou, Henan, China, 450008
Not Yet Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
4
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Not Yet Recruiting
5
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Not Yet Recruiting
Research Team
Y
Yan Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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