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New treatment option for HPV 16+ Recurrent or Metastatic Cancer
Official title Study of TI-0093 Injection With Recurrent/Metastatic HPV-16 Positive Solid Tumors
ClinicalTrials.gov ID: NCT07081984
What this study is testing
What is therapeutic tumor vaccine?
therapeutic tumor vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hpv 16+ recurrent or metastatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients must meet all the following to be eligible for participation in this study:
- 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.
You likely can't join if
- Patients who meet any of the following exclusion criteria cannot be enrolled:
- History of any therapeutic HPV vaccination. History of any live viral vaccine or attenuated live vaccine therapies within 4 weeks prior to the first...
- 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...
- Patients with underlying comorbidity will be excluded: A. Active known second malignancy, except for any of the following: basal cell carcinoma...
- Grade 2 and above myocardial infarction, grade 2 and above myocardial ischemia, or grade 2 and above heart failure based on New York Heart...
See the full eligibility criteria
Who can join
- Patients must meet all the following to be eligible for participation in this study:
- 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.
- 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...
- 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...
What rules you out
- Patients who meet any of the following exclusion criteria cannot be enrolled:
- 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...
- 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...
- 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...
- Known positive test results for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS). Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow...
- History of gastrointestinal perforation, gastrointestinal fistula or female reproductive tract fistula within 6 months prior to the first dose of TI-0093 injection. Except for those recovered after treatment judged by...
- Pleural effusion, ascites or pericardial effusion requires puncture aspiration or drainage within 2 weeks prior to the enrollment.
- Grade 3 and above immune-related AEs or any immune-related AE lead to discontinuation of prior immunotherapy.
- Any previous AE has not been improved to Grade 1 and below (except for patients with hair loss, grade 2 peripheral neurotoxicity, stable hypothyroidism after hormone replacement therapy or other AEs with no safety risk...
- Asplenia or insufficiency of spleen function caused by infarct of spleen or thrombosis of splenic vein.
- Systemic treatment with corticosteroids (≥ 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days prior to the first dose of TI-0093 injection.
- Washout period for any previous immunomodulatory drugs such as thymosin, interleukin-2, and interferon: last treatment is within 4 weeks prior to prior to the first dose of TI-0093 injection.
- Washout period for any previous anticancer therapy prior to the first dose of TI-0093 injection:
- Last treatment is within 4 weeks for chemotherapy, biologic therapy, target therapy or immunotherapy.
- Last treatment is within 2 weeks for radiotherapy, endocrine therapy or oral fluorouracil drugs.
- Last treatment is within 7 days for anticancer Chinese medicine.
- Last treatment is within 6 weeks for nitrosoureas and mitomycin.
- Last treatment with investigational product is within 5 half-lives or 4 weeks (which is longer).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.