OncoMatch/Clinical Trials/NCT06581419
A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors
Is NCT06581419 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies IAP0971 for advanced malignant neoplasm.
Treatment: IAP0971 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) positive (TPS ≥50%) (TPS ≥50%)
PD-L1 positive (TPS≥50%) as determined by IHC
Required: EGFR wild-type
patients were negative for epidermal growth factor receptor (EGFR)...by immunohistochemistry
Required: ALK wild-type
patients were negative for...anaplastic lymphoma kinase (ALK) by immunohistochemistry
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: immunotherapy (anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody), immune cell therapy, any treatment targeting the mechanism of tumor immune action)
previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 /PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the mechanism of tumor immune action
Lab requirements
Blood counts
ANC ≥1.5×10^9/L, PLT ≥100×10^9/L, HGB ≥90 g/L (no blood transfusion or hematopoietic stimulation therapy within 14 days)
Kidney function
serum creatinine ≤1.5x ULN; if >1.5x ULN, creatinine clearance (Ccr) ≥50 mL/min (Cockcroft-Gault)
Liver function
total bilirubin (TBIL) ≤1.5x ULN (except Gilbert's syndrome); AST/ALT ≤3.0x ULN (≤5.0x ULN with liver metastasis or liver cancer); total bilirubin ≤3.0x ULN with liver metastasis or liver cancer
Cardiac function
QTcF ≤470 ms; NYHA class <II; LVEF ≥50%; no severe cardiac rhythm/conduction abnormalities; no acute coronary syndrome, CHF, aortic dissection, stroke, or other grade 3+ cardiovascular/cerebrovascular events within 6 months; no clinically uncontrolled hypertension
adequate organ function: ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06581419 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD274?
Yes, CD274 positive (TPS ≥50%) is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify