Actively Recruiting
A Clinical Trial to Evaluate 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
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of IAP0971 in Patients with Advanced Malignant Tumors.
CONDITIONS
Official 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 between 18 and 75 years, male or female
- For Phase Ib: Advanced or metastatic malignant solid tumor confirmed by histopathology, with no suitable standard treatment or refusal of standard treatment
- For Phase II: Locally advanced (stage IIIB or IIIC) or metastatic (stage IV) non-small cell lung cancer not suitable for complete resection
- No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC; patients with prior adjuvant/neoadjuvant chemotherapy or radical treatment allowed if progression occurred at least 6 months after last treatment
- PD-L1 positive (TPS 60;50%) by immunohistochemistry, and negative for EGFR and ALK
- At least one measurable tumor lesion per RECIST 1.1
- ECOG performance status of 0 to 1
- Estimated survival time of 60;3 months
- Adequate organ function including hematological, hepatic, renal, and coagulation parameters
- Agree to use reliable contraception during and for specified periods after the trial if of childbearing potential
- Voluntarily sign a written informed consent form
You will not qualify if you...
- Presence of small cell lung cancer components or sarcomatoid lesions (Phase II)
- Prior immunotherapy including immune checkpoint inhibitors or immune cell therapy (Phase II)
- Receipt of chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks prior to first dose, with some exceptions
- Use of other investigational drugs within 4 weeks before first dose
- Use of systemic glucocorticoids or immunosuppressive agents within 14 days before first dose, except for certain topical or short-term uses
- Unresolved adverse reactions from prior anti-tumor treatments above grade 1
- Major surgery or significant trauma within 4 weeks before first dose or need for elective surgery during trial
- History of allogeneic hematopoietic stem cell or organ transplantation
- Brain or meningeal metastases with symptoms
- Active infections requiring intravenous treatment
- Immunodeficiency diseases including HIV
- Active hepatitis B or C infections
- Vaccination with live vaccines within 4 weeks before first dose
- Hypersensitivity to antibody drugs or study drug components
- Serious or uncontrolled lung diseases that may affect treatment
- History of serious cardiovascular or cerebrovascular diseases within 6 months
- Active or recurring autoimmune diseases except stable autoimmune thyroid disease or type I diabetes
- Other malignant tumors within 5 years except certain treated cancers
- Clinically uncontrolled third-space effusions
- Known alcohol or drug dependency
- Mental disorders or poor compliance
- Pregnancy or breastfeeding
- Other serious systemic diseases or conditions making the participant unsuitable for the study in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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