OncoMatch/Clinical Trials/NCT06690476
Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of IPM514 in Patients with Esophageal Squamous Cell Carcinoma
Is NCT06690476 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Dose escalation(IPM514 monotherapy) and Dose expansion (IPM514 combined with tislelizumab) for esophageal squamous cell carcinoma.
Treatment: Dose escalation(IPM514 monotherapy) · Dose expansion (IPM514 combined with tislelizumab) · Neoadjuvant therapy cohort(IPM514 combined with tislelizumab, cisplatin and paclitaxel) — This is a open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of IPM514 in patients with esophageal squamous cell carcinoma. This study consists of dose escalation phase (IPM514 monotherapy) ，dose expansion phase (IPM514 combined with anti-PD-1 antibody) and the neoadjuvant therapy cohort(IPM514 combined with anti-PD-1 antibody, cisplatin and paclitaxel).The dose escalation and dose expansion stages will include patients with unresectable advanced, recurrent or metastatic ESCC who have failed first-line treatment. After confirming the preliminary safety and effectiveness in the dose escalation and dose expansion stages, a neoadjuvant therapy cohort study will be developed, and resectable ESCC subjects will be included.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: PD-1 antibody combined with platinum-based chemotherapy — first-line or neoadjuvant/adjuvant
After at least one line of systemic treatment (PD-1 antibody combined with platinum-based chemotherapy) has progressed or is intolerable. Tumor recurrence/progression during neoadjuvant/adjuvant immunotherapy combined with platinum-containing chemotherapy. Patients with disease recurrence within 6 months after completing neoadjuvant/adjuvant treatment, and this neoadjuvant/adjuvant treatment is also defined as first-line treatment.
Cannot have received: mRNA vaccine
Prior treatment with an mRNA vaccine.
Cannot have received: any anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, immunotherapy, biological therapy, or investigational therapy)
Exception: within 28 days or 5 half-lives (whichever is shorter but at least 14 days) of the first study drug administration
Subjects received any anti-tumor therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, and biological therapy, or any investigational therapy within 28 days or 5 half-lives (whichever is shorter but at least 14 days) of the first study drug administration
Cannot have received: major surgery
Exception: within 4 weeks before the first administration or expected during the study
Subjects received major surgery within 4 weeks before the first administration or are expected to receive major surgery during the study
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 90 g/L
Kidney function
Serum creatinine ≤ 1.5 × ULN, or creatinine clearance rate (Cockcroft-Gault formula) ≥ 45 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN, ≤ 5 × ULN for those with liver metastasis
Cardiac function
QTc interval ≤ 450 ms for men and ≤ 470 ms for women; Left ventricular ejection fraction ≥ 50%
The organ function level in the screening period must meet the following requirements (no blood transfusion or blood products, no use of hematopoietic stimulating factors and other drugs to correct the number of blood cells before the examination): Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 100 × 10^9/L; Hemoglobin (Hb) ≥ 90 g/L; Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, ≤ 5 × ULN for those with liver metastasis; Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Cockcroft-Gault formula) ≥ 45 mL/min; International normalized ratio (INR), prothrombin time (PT) ≤ 1.5 × ULN; QTc interval calculated according to the Fridericia standard, ≤ 450 ms for men and ≤ 470 ms for women; Urine routine/24-hour urine protein quantification: Urine protein qualitative ≤ 1+ (if urine protein qualitative ≥ 2+, then 24-hour urine protein < 1 g can be enrolled); Cardiac function: Left ventricular ejection fraction ≥ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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