Actively Recruiting
A Phase Ib/IIa, Multicenter, Open-label 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
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ILB2109 and Toripalimab in patients with advanced or metastatic solid tumors that have progressed or have no effective standard treatment. This multicenter, open-label phase Ib/IIa study aims to assess the safety, tolerability, and preliminary efficacy of this combination therapy, followed by a focused evaluation of its effectiveness in selected solid tumor types. The study has two parts: dose escalation and expansion. During dose escalation, participants receive ILB-2109 tablets daily in 21-day cycles and Toripalimab injections intravenously every 21 days. The dose escalation follows a 3+3 design across two cohorts. After identifying the appropriate dose, the expansion phase will assess efficacy in 10 specific tumor types. Participants receive the combination therapy throughout these phases. Participants will be monitored regularly with safety assessments and evaluations of tumor response using imaging and tumor markers following RECIST v1.1 criteria. Researchers will measure treatment-related side effects, drug levels in the blood, and survival outcomes over up to 36 months. The study includes assessments of dose-limiting toxicities, maximum tolerated dose, objective response rate, progression-free survival, and overall survival to understand both safety and efficacy over time.
CONDITIONS
Brief 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
- ECOG Performance Status of 2 or less
- Expected life expectancy of at least 3 months
- Measurable or evaluable disease according to RECIST v1.1 criteria
- Laboratory values within specified limits for blood counts, liver and kidney function, heart function, and coagulation
- 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 surgical sterility
- Ability to provide written informed consent
You will not qualify if you...
- Recent systemic anti-tumor therapy within 3 weeks, with some exceptions
- Use of other investigational treatments within 4 weeks
- Gastrointestinal diseases affecting drug absorption
- Uncontrolled fluid accumulation
- Symptomatic CNS metastasis or recent CNS lesion growth
- Severe cardiovascular diseases or recent cardiac events
- Risk factors for QT prolongation or use of QT-prolonging medications
- Poorly controlled chronic diseases including diabetes and hypertension
- Current diagnosis or history of serious lung diseases or infections
- Autoimmune diseases requiring systemic therapy within 2 years except stable thyroid and atopic diseases
- Active infections requiring IV antibiotics
- Known HIV, active hepatitis B or C, or syphilis infection
- Recent use of systemic steroids or immune-modulating treatments
- Planned live vaccination during the study period
- Major surgery within 4 weeks
- Previous bone marrow or organ transplant
- Psychiatric disease or substance abuse affecting compliance
- Unresolved high-grade toxicities from prior therapies except specified exceptions
- History of severe immune-related adverse events from immunotherapy
- Allergy to study drugs ILB-2109 or Toripalimab
- Pregnancy or breastfeeding
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive ILB-2109 tablets daily and Toripalimab injections every 21 days as part of combination therapy to treat advanced solid malignancies.
Visits every 21 days for drug administration and assessment
Trial Site Locations
Total: 1 location
1
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
Research Team
X
Xue Wang
Y
Yan Li, M.D.
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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