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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
therapeutic tumor vaccine
Biological/VaccineTI-0093 injection will be administered intramuscularly on Day1, Day8, Day15, Day29 and Day43.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: TI-0093 injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse Events (AEs)
The safety profiles of TI-0093 injection will be assessed in terms of severity, seriousness, frequency of AEs, laboratory results, vital signs, physical examinations, and 12-lead electrocardiogram of the patients enrolled in the study.
Time frame
From enrollment to 28 days post the last dose of TI-0093 injection2
DLTs
DLTs will be assessed for at least 28 days after the first dose TI-0093 injection of a given regimen. Toxicities will be assessed by the National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5.0.
Time frame
From enrollment to 3 months.3
RP2D
The RP2D will be determined based on the observation of MTD.
Time frame
From enrollment to 3 months. Source ClinicalTrials.gov