OncoMatch/Clinical Trials/NCT07081984
Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors
Is NCT07081984 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies therapeutic tumor vaccine for hpv 16+ recurrent or metastatic cancer.
Treatment: therapeutic tumor vaccine — This is a phase I, open-label, dose escalation study to assess the safety, tolerability, efficacy and immunogenicity of TI-0093 injection in patients with recurrent or metastatic HPV-16 positive solid tumors. The primary objectives of the study are to assess safety and tolerability of TI-0093 injection in patients with recurrent or metastatic solid tumors, and to determine the maximum tolerated doses (MTDs) and recommended Phase 2 doses (RP2Ds) of TI-0093 injection.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Head and Neck Squamous Cell Carcinoma
Cervical Cancer
Biomarker criteria
Required: HPV16 positive
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: therapeutic hpv vaccination
Cannot have received: live viral vaccine or attenuated live vaccine therapies
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 ×10^9/L, Platelet count ≥ 100 × 10^9/L, Hemoglobin ≥ 9 g/dL (all without transfusion or growth factor within 2 weeks prior to study treatment)
Kidney function
creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula) or serum creatinine < 1.5 × ULN
Liver function
Aspartate transaminase and alanine aminotransferase ≤ 3 × ULN (patients with liver metastasis < 5 × ULN), and total bilirubin ≤ 1.5 × ULN (patients with Gilbert's Syndrome ≤ 3 × ULN)
Cardiac function
Left ventricular ejection fraction ≥ 50% measured by echocardiogram
Absolute neutrophil count ≥ 1.5 ×10^9/L, without the use of granulocyte colony stimulating factors such as filgrastim within 2 weeks prior to study treatment. Platelet count ≥ 100 × 10^9/L without transfusion within 2 weeks (≤ 14 days) prior to study treatment. Hemoglobin ≥ 9 g/dL without transfusion or erythropoietin within 2 weeks (≤ 14 days) prior to study treatment. Aspartate transaminase and alanine aminotransferase ≤ 3 × ULN (patients with liver metastasis < 5 × ULN), and total bilirubin ≤ 1.5 × ULN (patients with Gilbert's Syndrome ≤ 3 × ULN). Adequate renal function defined by either a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula) or serum creatinine < 1.5 × ULN. Prothrombin time ≤ 1.5 × ULN; activated partial thromboplastin time ≤ 1.5 × ULN; international normalized ratio ≤ 1.5 × ULN. Left ventricular ejection fraction ≥ 50% measured by echocardiogram.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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