Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTherorna
About this trial
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
Qualifiers
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.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- therapeutic tumor vaccine
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov