Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors

Launched by THERORNA · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called TI-0093 for people with certain types of cancer that have come back or spread, and that are linked to a virus called HPV-16. Specifically, it includes cancers like head and neck cancer and cervical cancer that are positive for HPV-16. The main goal of this early-stage (Phase 1) study is to find out if TI-0093 is safe and well-tolerated, and to determine the best dose to use in future studies. The study will carefully watch participants for side effects and how their cancer responds to the treatment.

People who might be eligible to join are adults aged 18 to 75 whose tumors test positive for HPV-16, who have advanced cancer that has not responded to standard treatments or for which no other standard treatment exists. Participants need to be generally healthy enough to take part, with a good level of daily functioning and a life expectancy of at least 12 weeks. Before starting treatment, there will be a screening period, then participants will receive TI-0093 injections with close monitoring for side effects and effectiveness, followed by a safety check after the last dose. Certain health conditions, recent treatments, or pregnancy would exclude someone from joining. If you or a loved one fit these criteria and are interested, this study may offer a new option to explore under careful medical supervision.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • -
• Participant must meet all the following inclusion criteria to be eligible for participation in this study:
• • 1. Voluntarily sign the informed consent form (ICF) approved by the Ethics Committee.
• • 2. Able to comply with the visit plans, treatment plans, laboratory tests and other requirements of the study visit schedule.
• • 3. The DNA test result of HPV16 in the tumor tissue of the target indication in this study was positive.
• • 4. 18 to 75 years (inclusive) of age at the time of informed consent.
• • 5. ECOG performance: 0-1, with no deterioration in the past two weeks.
• • 6. Estimated life expectancy of more than 12 weeks.
• • 7. Any histologically or cytologically confirmed unresectable solid tumor malignancy (Head and neck squamous cell carcinoma is preferred, and HPV16-positive malignant tumors such as cervical cancer are also accepted) that is advanced or metastatic and has failed standard therapy, or for which no further standard therapy is available.
• • 8. At least 1 measurable lesion at baseline according to the definition of RECISTv1.1.
• • 9. Neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count ≥ 100 × 10\^9/L; and hemoglobin ≥ 90 g/L (No plasma/blood components were transfused within 2 weeks before the first trial drug treatment, and hematopoietic factors such as granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GMCSF), and erythropoietin were not used).
• • 10. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (If patient has known liver metastasis, then \< 5xULN), and total bilirubin ≤ 1.5 × ULN (Patients who have serum bilirubin increases due to documented underlying Gilbert's Syndrome ≤ 3 × ULN).
• • 11. Creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula) or serum creatinine (SCr) \< 1.5 × ULN.
• • 12. Prothrombin time (PT) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; international normalized ratio (INR) ≤ 1.5 × ULN.
• • 13. Left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiogram.
• • 14. Females of childbearing potential and males whose partners are of childbearing potential agree to the use effective contraception from signing ICF to 90 days after the last dose of study drug; The test results of HCG in the blood of females of childbearing potential should be negative within 7 days prior to the first dose of study drug.
• Exclusion Criteria:
• Participants who meet any of the following exclusion criteria can not be included in this study:
• • 1. A history of any therapeutic HPV vaccination; live viral vaccine or attenuated live vaccine therapies within 4 weeks prior to the first dose of study drug.
• • 2. History of life-threatening hypersensitivity or known to be allergic to any ingredients contained in the TI-0093 drug formulation.
• • 3. Females who are pregnant or breastfeeding, or participants who plan to donate sperm/eggs during the study period (From signing the ICF to 90 days after the last dose of study drug).
• 4.Patients with underlying comorbidity will be excluded:
• • 1. Active known second malignancy except for any of the following: adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer, non-muscle invasive bladder cancer; any other cancer from which the patient was treated by surgery alone and has been disease-free survival for ≥ 5 years.
• • 2. Symptomatic/unstable brain metastases requiring steroid and/antiepileptic drug treatment, meningeal metastases, or spinal cord compression within 28 days prior to the first dose of study drug.
• • 3. A history of severe pneumonia such as interstitial lung disease within 6 months prior to the administration of the first dose of study drug.
• • 4. Participants who have undergone major surgery within 4 weeks prior to the first dose of study drug, are in the postoperative recovery period (Presence of risk for clinical study participation per the investigator), or are scheduled for surgery during the study, except for local surgeries such as core needle biopsy or prostate biopsy, but provided that the local surgery has been completed at least 24 hours before the day of the first dose of study drug.
• • 5. Pulmonary embolism, deep vein thrombosis or arterial/venous thrombosis events, such as cerebrovascular accidents (Such as transient ischemic attacks, cerebral hemorrhage, cerebral infarction) within 6 months prior to the first dose of study drug.
• • 6. Active bleeding symptoms or disease (such as active hemoptysis, gastrointestinal bleeding, and hemorrhagic gastric ulcer) within 4 weeks prior to the first dose of study drug.
• • 7. Any alcohol dependence (Averagely more than 2 units of alcohol per day (1 unit = 360 ml of beer, 45 ml of 40% liquor, or 150 ml of wine), drug abuse and unable to quit, or mental disturbance during the screening period, which may affect safety evaluations or the compliance of the participants in the judgment of the investigator.
• • 8. Patients with active autoimmune disease or symptoms (including celiac disease) that required systemic use of pharmacologic dose of corticosteroid and/or immunosuppressant within 4 weeks prior to the first dose of study drug. Exceptions are patients with vitiligo, resolved asthma/atopy, and type 1 diabetes mellitus or hypothyroidism that can be managed by replacement therapy.
• 9. Any evidence of severe or uncontrolled systemic diseases, including:
• • 1. Grade ≥2 myocardial infarction, Grade ≥2 myocardial ischemia, Grade ≥2 heart failure according to the HYHA classification within 6 months prior to the first dose of study drug; any arrhythmia requiring treatment during the screening period(including QTc≥ 480ms); or uncontrolled hypertension during the screening period (Systolic blood pressure more than equal to 150 mmHg or diastolic blood pressure of more than equal to 95 mmHg with antihypertensive therapy).
• • 2. Any active or uncontrolled infection (Grade ≥2 NCI CTCAE 5.0 standard); uncontrolled diabetes (HbA1c ≥ 7.5%), asthma, clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction during the screening period.
• • 3. Active hepatitis B (Both hepatitis B virus surface antigen being positive and Hepatitis B virus (HBV) 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.
• • 4. Diagnosis of acquired and congenital immunodeficiency including HIV infected, prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC)/bone marrow (BM) transplantation.
• • 5. A history of gastrointestinal perforation, gastrointestinal fistula, or female reproductive tract fistula (such as vesicovaginal fistula, urethral vaginal fistula, and vesicovaginal fistula) within 6 months prior to the first dose of study drug. Except for perforations or fistulas treated by resection or repair and have been recovered in the judgment of the investigator.
• • 6. Pleural effusion, ascites, or pericardial effusion, which requiring puncture aspiration/drainage within 2 weeks before the screening period.
• • 5. Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
• • 6. Any unresolved toxicities from prior therapy greater than NCI CTCAE version 5.0 Grade 1 during the screening except for those with no risk for clinical study participation per the investigator, such as, but not limited to alopecia, Grade 2 neuropathy, or stable hypothyroidism insufficiency after hormone replacement therapy.
• • 7. No spleen or functional asplenia (Such as loss of spleen function after direct vascular injury caused by splenic infarction and splenic vein thrombosis).
• • 8. Systemic treatment with corticosteroids (≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first dose of study drug.
• • 9. Treatment with immunomodulatory drugs, such as, but not limited to thymosin, interleukin-2, and interferon within 14 days prior to the first dose of study drug.
• • 10. Anticancer therapy (Including chemotherapy, biologic therapy, target therapy, or immunotherapy) within 4 weeks prior to the first dose of study drug; radiotherapy, endocrine therapy, or treatment of oral fluorouracil drugs within 2 weeks; anticancer Chinese medicine within 7 days; and treatment of nitrosyrea or mitomycin C within 6 weeks.
• • 11. Investigational agent and medical apparatus within 5 half-lives or 4 weeks, whichever is shorter, prior to the screening.
• • 12. Any other disease or clinically significant abnormality in laboratory parameters, which in the judgment of the investigator might compromise the safety of the patient or integrity of the study, interfere with the patient participation in the trial or compromise the trial objectives.
• • -