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New treatment option for Solid Tumors
Official title Personalized Neoantigen Peptide Vaccines for Solid Tumors
ClinicalTrials.gov ID: NCT07002203
What this study is testing
What is Personalized Neoantigen Peptide Vaccine?
Personalized Neoantigen Peptide Vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for solid tumors.
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 clinical trial is studying the safety and efficacy of a personalized cancer vaccine called a neoantigen peptide vaccine in patients with solid tumors. These vaccines are custom-made for each patient using specific mutations (neoantigens) found in their own tumor.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Age: 20 years or older.
- Language proficiency: Able to read and understand Thai clearly.
- Consent: Willing to provide informed consent and sign a participation agreement.
- Life expectancy: Estimated to be at least 6 months from the date of consent.
- Eligibility from prior research: Must have participated in the SQK01-002A research project and have tumor tissue confirmed as suitable for neoantigen...
You likely can't join if
- History of hypersensitivity to peptide vaccines or related substances.
- Autoimmune disease history.
- Previous treatments that significantly suppress or impair immune function.
- Refusal of current standard-of-care treatment.
- Active brain or central nervous system metastases unless well-controlled with steroids ≤ 10 mg/day prednisolone.
- Presence of more than one active cancer type.
See the full eligibility criteria
- Age: 20 years or older.
- Language proficiency: Able to read and understand Thai clearly.
- Consent: Willing to provide informed consent and sign a participation agreement.
- Life expectancy: Estimated to be at least 6 months from the date of consent.
- Eligibility from prior research: Must have participated in the SQK01-002A research project and have tumor tissue confirmed as suitable for neoantigen peptide vaccine production.
- Performance status: ECOG performance status of 0-2 with stable organ function, no rapid disease progression, or impending organ failure.
- Cancer diagnosis: Clinically and pathologically confirmed cancer diagnosis, with supporting radiological evidence.
- Cancer stage-specific criteria: i. Advanced cancer: Suitable for immune checkpoint inhibitors (ICIs) and shows resistance to prior therapies, with measurable lesions based on mRECIST1.1 criteria. ii. Early-stage cancer...
- Laboratory parameters: i. Lymphocyte count ≥ 800 cells/μL. ii. Neutrophil count ≥ 1,500 cells/μL. iii. Platelet count ≥ 75,000 cells/μL. iv. AST ≤ 2.5 times the upper limit of normal (ULN). v. ALT ≤ 2.5 times ULN. vi...
- Consent to Avoid Pregnancy or Causing Pregnancy Under the Following Criteria i. Female participants not of reproductive age, defined as having undergone a hysterectomy and/or bilateral oophorectomy, experiencing...
- History of hypersensitivity to peptide vaccines or related substances.
- Autoimmune disease history.
- Previous treatments that significantly suppress or impair immune function.
- Refusal of current standard-of-care treatment.
- Active brain or central nervous system metastases unless well-controlled with steroids ≤ 10 mg/day prednisolone.
- Presence of more than one active cancer type.
- Uncontrolled cardiac conditions, such as unstable angina or advanced heart failure (NYHA Class III/IV). i. Participants with pacemakers may be eligible if stabilized for at least 1 month before vaccination.
- Receipt of any other vaccines within 28 days before the first neoantigen peptide vaccine.
- Participation in another clinical trial.
- Use of immunosuppressive drugs or steroids \> 10 mg/day prednisolone (except inhaled/intranasal corticosteroids).
- Pre-existing conditions that could compromise the how well it works or safety of the peptide vaccine.
- Pregnancy or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Bangkok, Thailand
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 study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bangkok, Thailand. 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.