Actively Recruiting
Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16
Led by Sound Biopharmaceuticals Ltd. · Updated on 2025-07-01
68
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, multi-center, multi-cohort phase I clinical study designed to evaluate safety, tolerability, pharmacokinetics and initial efficacy of FTL008.16 in patients with advanced and metastatic solid tumors.
CONDITIONS
Official Title
Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent with good compliance
- Age between 18 and 75 years at consent
- Expected survival of at least 3 months
- Histologically or cytologically confirmed advanced solid tumors likely expressing 5T4 antigen, including multiple specified tumor types
- Disease progression after or intolerance to standard treatments or no standard treatment available
- At least one measurable or evaluable lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to provide required tumor tissue specimen
- Good organ function based on screening laboratory tests
- Sexually active females of childbearing potential must use effective contraception during and for 6 months after treatment
- Sexually active males with female partners of childbearing potential must use highly effective contraception during and for 6 months after treatment
You will not qualify if you...
- History of hypersensitivity to study drug excipients or any monoclonal antibody
- Other malignancies within 5 years except certain cured cancers with no recurrence risk
- Anti-tumor systemic treatments received within 4 weeks prior to study
- Previous cell immunotherapy (CAR-T) or anti-CD137/anti-5T4 antibody treatments
- Unresolved prior treatment adverse reactions above grade 1 except specified exceptions
- Previous allogeneic stem cell or solid organ transplantation
- Active central nervous system tumors or related complications unless treated and stable
- Active or suspected autoimmune diseases except controlled type 1 diabetes or mild skin diseases
- Uncontrolled pleural effusion, ascites, or pericardial effusion
- Severe cardiovascular or cerebrovascular diseases as specified
- History of certain pulmonary diseases requiring steroids or symptomatic bronchospasm
- Active tuberculosis or infections requiring intravenous treatment within 14 days
- Positive HIV or active syphilis infection
- Autoimmune liver disease, decompensated cirrhosis, or active hepatitis B or C
- Recent systemic immunosuppressive therapy except allowed low-dose corticosteroids
- Live vaccinations within 4 weeks before study
- Major surgeries within 4 weeks before study except vascular access
- History of substance abuse or uncontrolled mental disorders
- Pregnant or lactating women
- Other severe medical or psychiatric conditions increasing study risk
- Participation in other clinical trials within 28 days prior to study start or planned anticancer therapy during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
C
CMO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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