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Tests treatment safety and results for Advanced Solid Tumor Malignancies
Official title Phase I Study of the Safety, Tolerability, and Efficacy of an Engineered Mitochondrial Vaccine in Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06927297
What this study is testing
What is Engineered mitochondrial vaccine?
Engineered mitochondrial vaccine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for advanced solid tumor malignancies.
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 study is a dose-escalation, prospective clinical trial to assess the safety, tolerability, and preliminary therapeutic efficacy of engineered mitochondria expressing specific tumor antigen in patients with advanced solid tumors.
- 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 aged 18 to 75 years at the time of acquisition informed consent form.
- Patients with advanced malignant solid tumors such as non-small cell lung cancer or colorectal cancer, confirmed by histology or cytology, who are...
- The presence of at least one measurable or evaluable lesion according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2.
- Predicted survival time ≥3 months.
You likely can't join if
- The patient has a history of other tumors in the past, except for the history of malignant tumors that have been cured and have not recurred within 5...
- Have any uncontrolled clinical diseases (e.g., diseases of the respiratory system, circulatory system, digestive system, nervous system, hematologic...
- Have any active autoimmune disease or a history of autoimmune disease. Participants with asthma for which medical intervention with bronchodilators...
- Allergy to the trial drug (including any excipients). Previous history of severe allergy to any drug, food or vaccination, such as anaphylactic...
- There are contraindications to subcutaneous injection.
- Received prior antitumor therapeutic vaccine or cellular immunotherapy.
See the full eligibility criteria
- Patients aged 18 to 75 years at the time of acquisition informed consent form.
- Patients with advanced malignant solid tumors such as non-small cell lung cancer or colorectal cancer, confirmed by histology or cytology, who are unable to receive or tolerate standard treatments, or who refuse...
- The presence of at least one measurable or evaluable lesion according to RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2.
- Predicted survival time ≥3 months.
- The main organs are functioning well and the following requirements are met within 7 days before receiving treatment: ① Hemoglobin (HGB) ≥80 g/L (no blood transfusion within 14 days); Absolute neutrophil count (ANC)...
- Men of childbearing potential and women of childbearing age voluntarily use effective contraceptive methods (e.g., condoms, intrauterine devices, spermicides) from the time of signing the informed form until 6 months...
- The washout period of previous anti-tumor therapy should be at least 4 weeks, and the washout period of molecular targeted drugs should be at least 5 half-lives. Palliative radiotherapy needs to have been completed for...
- The patient has a history of other tumors in the past, except for the history of malignant tumors that have been cured and have not recurred within 5 years before screening, such as basal cell carcinoma of the skin...
- Have any uncontrolled clinical diseases (e.g., diseases of the respiratory system, circulatory system, digestive system, nervous system, hematologic system, urogenital system, endocrine system) or psychiatric or other...
- Have any active autoimmune disease or a history of autoimmune disease. Participants with asthma for which medical intervention with bronchodilators was required could not be included.
- Allergy to the trial drug (including any excipients). Previous history of severe allergy to any drug, food or vaccination, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura...
- There are contraindications to subcutaneous injection.
- Received prior antitumor therapeutic vaccine or cellular immunotherapy.
- Participated in other drug or device clinical trials 4 weeks before screening.
- Study participants on systemic therapy with corticosteroids (\>10 mg/ day of prednisone or equivalent doses of other glucocorticoids) or other immunosuppressive agents within 14 days before the first dose of vaccine...
- Before the first dose of the study drug. Any toxic effects from previous antineoplastic therapy have not recovered to NCI CTCAE grade 5.0 ≤1 (any degree of alopecia, other than grade 2 previous platinum-based...
- Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- Have a history of substance abuse or known medical, psychological, or social conditions such as alcohol or drug abuse.
- Have received any vaccine within 30 days before receiving the study vaccine or plan to receive any vaccine other than the study vaccine during the study.
- The presence of any other factor that was deemed by the investigator to preclude study participant entry into the trial or that study participant had any medical condition that could interfere with the assessment of the...
- Study participants who were unwilling or unable to comply with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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 Chengdu, Sichuan, 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.