OncoMatch/Clinical Trials/NCT07081984
Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors
Is NCT07081984 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07081984 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior therapeutic hpv vaccination, live viral vaccine or attenuated live vaccine therapies disqualifies patients from enrollment.
Does this trial require HPV16?
Yes, HPV16 positive is a required biomarker for enrollment.
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