Actively Recruiting
A Study of the ILB-3101 in Patients with Advanced Solid Tumors
Led by Innolake Biopharm · Updated on 2024-12-09
240
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients.
CONDITIONS
Official Title
A Study of the ILB-3101 in Patients with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent voluntarily.
- Age between 18 and 80 years.
- ECOG performance status score of 0 or 1.
- Expected survival longer than 12 weeks.
- Diagnosed with locally advanced or metastatic solid cancer that is refractory, resistant, untreatable, or without standard treatment options.
- Ability to provide archived tumor tissue samples, or enrollment may be allowed with sponsor discussion during dose escalation.
- At least one assessable tumor lesion present; measurable lesion required during dose escalation.
- Adequate bone marrow, liver, and kidney function as defined by specific laboratory values.
- Negative pregnancy test for females of childbearing potential.
- Agreement to use effective contraception during the study and for 90 days after last dose for participants of childbearing potential.
You will not qualify if you...
- Received systemic anti-tumor therapy within 3 weeks prior to first dose, except certain chemotherapy or hormonal therapies as specified.
- Participation in another clinical trial with investigational drugs within 4 weeks before dosing.
- History of other active malignant tumors within 3 years, except certain cured tumors.
- Clinically uncontrolled pleural, abdominal, or pericardial effusion.
- Uncontrolled central nervous system metastasis or cancerous meningitis, except stable, controlled cases meeting specific criteria.
- Use of drugs known to prolong QT interval or cause serious cardiac arrhythmias.
- Recent serious cardiovascular events or significant heart rhythm abnormalities.
- Clinically uncontrolled severe diseases including severe diabetes or refractory hypertension.
- Previous or current interstitial lung disease, excluding radiation pneumonitis not requiring hormone therapy.
- Uncontrolled systemic infections including HIV or syphilis requiring intravenous treatment.
- Positive hepatitis B or C viral load not under treatment.
- Use of systemic corticosteroids or immunosuppressants within 14 days prior to dosing, with some exceptions.
- Receipt of live attenuated vaccines within 4 weeks prior to dosing or planned during study.
- Major surgery or trauma within 4 weeks prior to dosing or planned elective surgery during study.
- History of stem cell or organ transplantation.
- Known alcohol or drug dependence.
- Mental disorders or poor compliance.
- Unresolved adverse reactions from prior anti-tumor treatments above grade 1.
- Known allergies to study drug components or similar antibodies.
- Pregnancy or breastfeeding.
- Investigator judgment of unsuitability for study participation for other reasons.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fundan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Y
Yan Li, MD
CONTACT
X
Xue Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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