Actively Recruiting
A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
Led by Innolake Biopharm · Updated on 2024-05-21
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, phase Ib/IIa study. The first part of the study will evaluate the safety, tolerability and preliminary efficacy of ILB2109 and Toripalimab in patients with locally advanced or metastatic solid malignancies. The second part of the study will evaluate the efficacy of ILB2109 and Toripalimab in patients with selected advanced solid malignancies.
CONDITIONS
Official Title
A Study of ILB2109 and Toripalimab in Patients With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Histologically or cytologically confirmed advanced, metastatic, or progressive solid tumors without effective standard therapy
- Eastern Collaborative Oncology Group (ECOG) Performance Status of 2 or less
- Expected life expectancy of 3 months or more
- Measurable disease by RECIST v1.1 or evaluable tumor markers
- Adequate laboratory values including neutrophil count, platelets, hemoglobin, liver enzymes, kidney function, coagulation tests, heart function, and QT interval
- Negative pregnancy test for women of childbearing potential
- Agreement to use effective birth control during the study and for 90 days after last dose, or surgically sterile
- Ability to provide written informed consent prior to screening procedures
You will not qualify if you...
- Systemic anti-tumor therapy within the past 3 weeks with some exceptions for certain drugs within 6 weeks or 2 weeks
- Investigational treatments within the past 4 weeks
- Gastrointestinal diseases affecting drug absorption
- Uncontrollable fluid build-up (third-spacing)
- Symptomatic or large CNS metastases or recent lesion growth
- Severe cardiovascular conditions including recent heart failure, angina, arrhythmia, heart attack, or embolism
- Risk factors for QT prolongation or use of QT-prolonging medications
- Poorly controlled chronic diseases such as diabetes or hypertension
- Current or history of certain lung diseases or infections
- Active autoimmune diseases requiring recent systemic therapy, except some stable conditions
- Active infections requiring IV antibiotics
- Known HIV or syphilis infection
- Active hepatitis B or certain hepatitis C infections
- Recent use of systemic steroids or immune-modulating treatments
- Planned live vaccinations during the study period
- Major surgery within the past 4 weeks
- Previous bone marrow or organ transplant
- Psychiatric illness or substance abuse affecting compliance
- Unresolved toxicities from prior therapy above grade 1 except specific exceptions
- History of severe immune-related adverse events from prior immunotherapy
- Allergy to ILB-2109 or Toripalimab
- Pregnancy or breastfeeding
- Other conditions deemed by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
Research Team
X
Xue Wang
CONTACT
Y
Yan Li, M.D.
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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