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

NCT07081984 | Recruiting Phase 1

• 1 other identifier: 0093101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV 16+ Recurrent or Metastatic Cancer; HNSCC; Cervical Cancer

Keywords

Therapeutic tumor vaccine; Circular RNA

Outcome Measures

Primary Outcomes (3)

• 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.

  From enrollment to 28 days post the last dose of TI-0093 injection

• 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.

  From enrollment to 3 months.

• RP2D

  The RP2D will be determined based on the observation of MTD.

  From enrollment to 3 months.

Study Arms (1)

TI-0093 injection

EXPERIMENTAL

Therapeutic tumor vaccine: TI-0093 injection. Different dose levels of TI-0093 injection. Route of administration: Muscle

Biological: therapeutic tumor vaccine

Interventions

therapeutic tumor vaccine BIOLOGICAL

TI-0093 injection will be administered intramuscularly on Day1, Day8, Day15, Day29 and Day43.

TI-0093 injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Absolute neutrophil count ≥ 1.5 ×10\^9/L, without the use of granulocyte colony stimulating factors such as filgrastim within 2 weeks prior to study treatment. Platelet count ≥ 100 × 10\^9/L without transfusion within 2 weeks (≤ 14 days) prior to study treatment. Hemoglobin ≥ 9 g/dL without transfusion or erythropoietin within 2 weeks (≤ 14 days) prior to study treatment.
• Aspartate transaminase and alanine aminotransferase ≤ 3 × upper limit of normal (ULN) (patients with liver metastasis \< 5 × ULN), and total bilirubin ≤ 1.5 × ULN (patients with Gilbert's Syndrome ≤ 3 × ULN).
• Adequate renal function defined by either a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula) or serum creatinine \< 1.5 × ULN.
• Prothrombin time ≤ 1.5 × ULN; activated partial thromboplastin time ≤ 1.5 × ULN; international normalized ratio ≤ 1.5 × ULN.
• Left ventricular ejection fraction ≥ 50% measured by echocardiogram.
• Females of childbearing potential and males whose partners are of childbearing potential agree to the use effective contraception from signing informed consent form to 90 days after the last dose of TI-0093 injection. The test results of HCG of females with childbearing potential should be negative within 7 days prior to the first dose of TI-0093 injection.

You may not qualify if:

• 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.
• Patients with underlying comorbidity will be excluded:
• A. Active known second malignancy, except for any of the following: basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer and non-muscle invasive bladder cancer, which were recovered from adequate clinical treatment, and other cancers treated by surgery alone whose disease-free survival were 5 years and above.
• B. Meningeal metastases, spinal cord compression or symptomatic brain metastases within 28 days prior to the first dose of TI-0093 injection (except for patients with prior brain metastases who were treated and clinically stable for 4 weeks without corticosteroid or antiepileptic drug treatment).
• C. History of severe pneumonia such as interstitial lung disease within 6 months prior to the first dose of TI-0093 injection.
• D. Major surgery within 4 weeks prior to the first dose of TI-0093 injection. E. Deep vein thrombosis or arterial embolism such as pulmonary embolism within 6 months prior to the first dose of TI-0093 injection.
• F. Active bleeding symptoms or diseases such as active hemoptysis, gastrointestinal bleeding and hemorrhagic gastric ulcer within 28 days prior to the first dose of TI-0093 injection.
• G. 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) which may affect safety assessment judged by the investigator. Drug abuse but unable to quit or mental disorders.
• H. Patients with active autoimmune disease or symptoms that required systemic use of pharmacologic dose of corticosteroid and/or immunosuppressant within 4 weeks prior to the first dose of TI-0093 injection. Exceptions are patients with vitiligo, resolved asthma/atopy, and type 1 diabetes mellitus or hypothyroidism that can be managed by replacement therapy.
• I. Severe or uncontrolled systemic diseases above:
• 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.

Sponsors & Collaborators

• Therorna: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Squamous Cell Carcinoma of Head and Neck; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Ye Guo

CONTACT

0086-457-13501678472; pattrickguo@gmail.com

The Drug Clinical Trial Institution of Shanghai East Hospital

CONTACT

021-38804518-28329; shdfgcp@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 24, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)