Actively Recruiting
Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors
Led by Therorna · Updated on 2025-11-24
12
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the study.
- Willing to follow visit plans, treatment plans, and study schedule requirements.
- Have HPV16 positive solid tumors.
- Be between 18 and 75 years old at consent.
- Have an ECOG performance status of 0 or 1 with no recent decline.
- Have an estimated life expectancy over 12 weeks.
- Have recurrent or metastatic HPV16 positive head and neck, cervical, or other carcinomas progressed after standard therapies or no further standard therapies available.
- Have at least one measurable tumor lesion at baseline per RECISTv1.1.
- Have adequate blood counts without recent need for transfusion or growth factors.
- Have liver function tests within defined limits.
- Have adequate kidney function.
- Have normal blood clotting tests.
- Have a left ventricular ejection fraction of at least 50%.
- Agree to use effective contraception if of childbearing potential during and 90 days after treatment and have a negative pregnancy test if applicable.
You will not qualify if you...
- History of therapeutic HPV vaccination or recent live viral/attenuated vaccine within 4 weeks.
- Known severe allergy to TI-0093 injection ingredients.
- Pregnant or breastfeeding females or planning sperm/egg donation during study period.
- Active second malignancy except certain skin cancers, in situ cervical cancer, treated non-muscle invasive bladder cancer, or other cancers with 5+ years disease-free survival.
- Recent brain or meningeal metastases, spinal cord compression, or symptomatic brain metastases.
- Severe pneumonia within 6 months.
- Major surgery within 4 weeks.
- Recent blood clots or active bleeding.
- Alcohol dependence or uncontrolled drug abuse/mental disorders.
- Active autoimmune disease needing systemic corticosteroids or immunosuppressants recently, with certain exceptions.
- Severe or uncontrolled systemic diseases including heart conditions, infections, hepatitis B or C, HIV/AIDS, recent organ transplants.
- Recent gastrointestinal perforation or fistula.
- Recent fluid accumulation needing drainage.
- Grade 3 or higher immune-related adverse events from prior immunotherapy.
- Unresolved prior adverse events above Grade 1 except certain conditions.
- Asplenia or spleen dysfunction.
- Recent systemic corticosteroids or immunosuppressant use.
- Recent use of immunomodulatory or anticancer therapies within specified washout periods.
- Other diseases or lab abnormalities compromising safety or study integrity as judged by investigator.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
Y
Ye Guo
CONTACT
T
The Drug Clinical Trial Institution of Shanghai East Hospital
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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