Actively Recruiting
A Phase Ib/II Clinical Trial to Evaluate the Effect of IAP0971 in Patients With Advanced Malignant Tumors
Led by SUNHO（China）BioPharmaceutical CO., Ltd. · Updated on 2024-02-20
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IAP0971 in patients with advanced malignant tumors in this Phase Ib/II clinical trial. The study aims to assess the safety, tolerability, and early effectiveness of IAP0971 in patients whose cancers have progressed despite standard treatments or who have limited treatment options. The trial is sponsored by SUNHO (China) BioPharmaceutical CO., Ltd. and focuses on solid tumors including advanced non-small cell lung cancer (NSCLC).
CONDITIONS
Brief Title
A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female.
- For Phase Ib: Advanced or metastatic malignant solid tumor confirmed by histopathology with no effective standard treatment or unsuitable for standard treatment.
- For Phase II: Locally advanced or metastatic non-small cell lung cancer (NSCLC) confirmed by histopathology, not suitable for complete resection.
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC before Phase II treatment.
- PD-L1 positive (TPS 50%) by immunohistochemistry; EGFR and ALK negative.
- At least one measurable tumor lesion per RECIST 1.1.
- ECOG performance status 0 to 1.
- Estimated survival time of at least 3 months.
- Adequate organ function and hematologic parameters.
- Agreement to use reliable contraception during and after the trial.
- Voluntary written informed consent.
You will not qualify if you...
- Small cell lung cancer components or sarcomatoid lesions (Phase II).
- Previous immunotherapy including checkpoint inhibitors or immune cell therapy (Phase II).
- Anti-tumor treatments within 4 weeks before first dose except specified exceptions (Phase Ib).
- Use of other investigational drugs within 4 weeks before first dose.
- Systemic glucocorticoids or immunosuppressive agents within 14 days before first dose.
- Unrecovered adverse reactions from prior cancer treatments above grade 1.
- Major surgery or significant trauma within 4 weeks before first dose.
- Prior allogeneic stem cell or organ transplantation.
- Symptomatic brain or meningeal metastases.
- Active infection requiring intravenous antibiotics.
- Immunodeficiency including HIV positive status.
- Active hepatitis B or C infection.
- Live vaccine within 4 weeks before first dose.
- Hypersensitivity to antibody drugs or study drug components.
- Serious lung diseases or cardiovascular conditions.
- Active or recurrent autoimmune diseases except stable thyroid disease and type I diabetes.
- Other malignant tumors within 5 years except certain treated cancers.
- Uncontrolled effusions unsuitable for enrollment.
- Alcohol or drug dependence.
- Mental disorders or poor compliance.
- Pregnant or breastfeeding women.
- Other serious systemic diseases or conditions making participation unsuitable.
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.
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive subcutaneous injections of IAP0971 every 3 weeks as part of their cancer treatment.
Visits every 3 weeks for injections with additional pharmacokinetic assessments on multiple days during each cycle
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
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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