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 2025-01-15
78
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase I: To evaluate the safety, tolerance and effectiveness of IAP0971 for the treatment of advanced malignant tumors. Phase II: Evaluation of IAP0971 therapy driver negative and PD-L1 positive (TPS≥50%) The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer.
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 old, any gender
- Phase I: Patients with advanced or metastatic malignant solid tumors who have failed standard treatments or have no standard options
- Phase II: Patients with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-small cell lung cancer not suitable for surgery or chemoradiotherapy
- Phase II: No prior systemic antitumor therapy for advanced NSCLC except specific prior treatments with disease progression at least 6 months after
- Phase II: PD-L1 positive (TPS 6550%) and negative for EGFR and ALK
- At least one measurable tumor lesion per RECIST 1.1 criteria
- ECOG performance status 0-1
- Predicted survival of at least 3 months
- Adequate organ function including blood counts, liver, kidney, and coagulation parameters
- Use of reliable contraception for patients of childbearing potential and negative pregnancy test for females of reproductive age
- Provided written informed consent
You will not qualify if you...
- Phase II: Small cell lung cancer or sarcomatoid lesion
- Phase II: Prior immunotherapy including checkpoint inhibitors or immune cell therapy
- Phase I: Antitumor therapy within 4 weeks before first dose, including chemotherapy, radiotherapy, biological, endocrine, or immunotherapy
- Use of small-molecule tyrosine kinase inhibitors, palliative local treatment, nonspecific immunomodulatory therapy, or Chinese herbal medicine with antitumor effects within 2 weeks before first dose
- Other investigational drugs or treatments within 4 weeks before study drug
- Systemic glucocorticoids or immunosuppressants within 14 days before first dose (except certain topical or short-term uses)
- Unrecovered adverse effects from prior antineoplastic therapy above grade 1 (except certain low-risk toxicities)
- Major surgery or trauma within 4 weeks before first dose or planned surgery during study
- Prior allogeneic stem-cell or organ transplantation
- Symptomatic brain metastases
- Active infections requiring intravenous therapy
- History of immunodeficiency or HIV positive
- Active hepatitis B or C infection
- Live vaccine within 4 weeks before first dose
- Known hypersensitivity to antibody drugs or PD-1/PD-L1 inhibitors
- Severe or uncontrollable lung diseases affecting respiratory function
- Severe cardiovascular or cerebrovascular diseases within 6 months before first dose
- Active or prior autoimmune disease with risk of recurrence except certain stable conditions
- Other malignancies within 5 years except certain treated cancers
- Clinically uncontrollable effusions
- Known alcohol or drug dependence
- Mental disorders or poor adherence
- Pregnant or lactating women
- Other serious systemic diseases or ineligibility as judged by investigator
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, 10021
Actively Recruiting
Research Team
Y
YuanKai Shi, doctor
CONTACT
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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