Actively Recruiting
Study of IAP0971 to Evaluate Safety and Effects in Advanced Tumors Phase I Dose Escalation and Phase II in Non-Small Cell Lung Cancer
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
Researchers are evaluating the safety, tolerance, and effectiveness of IAP0971 in adults with advanced malignant tumors, including those with advanced or metastatic non-small cell lung cancer (NSCLC) that is driver negative and PD-L1 positive. The study includes both Phase I and Phase II parts. Phase I focuses on safety and determining the maximum tolerated dose (MTD) through dose escalation, while Phase II explores the effectiveness of IAP0971 in a selected group of NSCLC patients who have not received prior systemic antitumor therapy for their advanced disease. The treatment involves administering IAP0971 every 3 weeks in a 3-week cycle. The Phase I dose-escalation phase identifies the recommended dose for Phase II. Phase II is an open-label, single-arm study assessing IAP0971's impact on tumor progression. Tumor assessments follow RECIST 1.1 criteria and occur every two cycles within the first 48 weeks, then every four cycles thereafter, continuing until disease progression or other study endpoints. Participants will undergo clinical observations, vital sign monitoring, and laboratory tests to monitor safety and adverse reactions. Tumor response is regularly evaluated using imaging. The study tracks adverse events, dose-limiting toxicities, and progression-free survival over up to two years or until disease progression. Participants' involvement includes multiple cycles of treatment and follow-up visits, with comprehensive safety and efficacy monitoring throughout the trial.
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
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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
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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