Actively Recruiting
Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL001
Led by Sound Biopharmaceuticals Ltd. · Updated on 2024-05-10
44
Participants Needed
3
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, multi-center, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics/pharmacokinetics and initial efficacy of FTL001 in patients with advanced and metastatic solid tumors.
CONDITIONS
Official Title
Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL001
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily sign informed consent before participating
- Age 18 to 75 years, any gender
- Expected survival longer than 3 months
- Histologically or cytologically confirmed advanced solid tumors
- Disease progressed after or intolerant to standard treatments, or no standard treatments available
- At least one measurable tumor lesion at baseline per RECIST v1.1
- ECOG performance status of 0 or 1
- Adequate organ function
- Fertile participants must agree to use effective contraception during the study and for 6 months after treatment
You will not qualify if you...
- History of other malignancies within 5 years except certain treated cancers with no risk of recurrence
- Anticancer therapy (chemotherapy, targeted, radiotherapy, immunotherapy) within 28 days before first dose
- Prior treatment with any anti-CD137 antibody or drug
- Unresolved adverse reactions from previous treatments above specified safety grades
- Previous allogeneic stem cell or solid organ transplant
- Active CNS tumors, seizures, spinal cord compression, or carcinomatous meningitis except stable treated cases
- Active or suspected autoimmune diseases excluding controlled type 1 diabetes and certain skin diseases
- Clinical symptoms or treatment for pleural fluid or ascites
- Severe cardiovascular or cerebrovascular disease as specified
- History of pulmonary diseases like interstitial pneumonia or symptomatic bronchospasm
- Active infection requiring IV anti-infectives or unhealed wounds within 14 days
- Positive for HIV antibodies
- Active hepatitis B or C, or certain liver diseases
- Active tuberculosis or suspected active TB
- Systemic corticosteroids or immunosuppressive drugs within 14 days before study
- Live vaccination within 4 weeks before study
- Major surgery within 4 weeks prior or planned within 30 days
- Pregnant or breastfeeding women
- Hypersensitivity to study drug components or monoclonal antibodies
- Prior cellular immunotherapy such as CAR-T
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
3
West China Hospital
Chengdu, Sichuan, China, 610041
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here