Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors (NCT07081984) | Clinical Trial Compass
RecruitingPhase 1
Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors
China12 participantsStarted 2025-11-11
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. The patient provides written informed consent for the study.
✓. Willing to comply with the visit plans, treatment plans, and other requirements of the study schedule.
✓. Previous HPV16+ solid tumors.
✓. 18 to 75 years of age at the time of informed consent.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks.
✓. Estimated life expectancy of more than 12 weeks.
✓. 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.
✓. Patients should have at least 1 measurable lesion at baseline according to the definition of RECISTv1.1.
Exclusion criteria
✕. History of any therapeutic HPV vaccination. History of any live viral vaccine or attenuated live vaccine therapies within 4 weeks prior to the first dose of TI-0093 injection.
✕. History of life-threatening hypersensitivity or known to be allergic to any ingredients contained in the TI-0093 injection.
✕. Females who are pregnant or breastfeeding. Patients who plan to donate sperm or eggs from signing informed consent form to 90 days post the last dose of TI-0093 injection.
What they're measuring
1
Adverse Events (AEs)
Timeframe: From enrollment to 28 days post the last dose of TI-0093 injection
✕. Patients with underlying comorbidity will be excluded:
✕. Grade 2 and above myocardial infarction, grade 2 and above myocardial ischemia, or grade 2 and above heart failure based on New York Heart Association (NYHA) classification within 6 months prior to the first dose of TI-0093 injection. Arrhythmia such as QTc ≥ 480ms needs to be treated and uncontrolled hypertension during the screening period.
✕. Any active or uncontrolled infection such as uncontrolled diabetes (defined as HbA1c ≥ 7.5%), asthma, clinically active diverticulitis, abdominal abscess or gastrointestinal obstruction during the screening period.
✕. Active hepatitis B (both hepatitis B virus surface antigen being positive and hepatitis B virus carriers with a viral load \> 200 IU/ml), active hepatitis C (both HCV antibody and RNA testing being positive), positive for treponema pallidum in serum or active tuberculosis during the screening period.
✕. Known positive test results for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.