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OncoMatch/Clinical Trials/NCT06581419

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

Is NCT06581419 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies IAP0971 for advanced malignant neoplasm.

Phase 1/2RecruitingSUNHO(China)BioPharmaceutical CO., Ltd.NCT06581419Data as of May 2026

Treatment: IAP0971Phase 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.

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Extracted eligibility criteria

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)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

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