Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Patients must meet all the following inclusion criteria to be eligible for participation in this study: 1. The patient provides written informed consent for the study. 2. Willing to comply with the visit plans, treatment plans, and other requirements of the study schedule. 3. Previous HPV16+ solid tumors. 4. 18 to 75 years of age at the time of informed consent. 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks. 6. Estimated life expectancy of more than 12 weeks. 7. Previous HPV16 positive head and neck, cervical and other carcinoma patients with recurrent or metastatic disease, who have progressed after standard therapies, or for whom no further standard therapies are available. 8. Patients should have at least 1 measurable lesion at baseline according to the definition of RECISTv1.1. 9. Absolute neutrophil count ≥ 1.5 ×10\^9/L, without the use of granulocyte colony stimulating factors such as fil