Solid TumorsPhase 1/2NCT07002203
Personalized Neoantigen Peptide Vaccines for Solid Tumors
A Phase 1/2 study testing Personalized Neoantigen Peptide Vaccine in people with Solid Tumors and Advanced Cancer, run by Seqker Biosciences, Inc. at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumors, Advanced Cancer, Recurrent Cancer
- What is being tested?
- Personalized Neoantigen Peptide Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2024to Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Cancer diagnosis: Clinically and pathologically confirmed cancer diagnosis, with supporting radiological evidence.
- Cancer stage-specific criteria:
- Advanced cancer: Suitable for immune checkpoint inhibitors (ICIs) and shows resistance to prior therapies, with measurable lesions based on mRECIST1.1 criteria.
- Early-stage cancer: High recurrence risk despite prior surgery and/or radiotherapy, with no current adjuvant treatment standard.
- Laboratory parameters:
- 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. Total bilirubin ≤ 1.5 times ULN. vii. Serum creatinine ≤ 1.5 times ULN.
- 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 continuous menopause for more than 12 months, or being over 60 years of age.
- Female participants of reproductive age must undergo a pregnancy test and have a confirmed negative result during the preparation phase and before the first day of vaccination. They must also consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and follow-up, and up to 120 days after the final treatment.
- Male participants must consent to using contraception with an efficacy rate greater than 99%, as recommended by the principal investigator, throughout the study duration, including the preparation phase and up to 120 days after the final treatment.
Who cannot join
- 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.
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- Uncontrolled cardiac conditions, such as unstable angina or advanced heart failure (NYHA Class III/IV).
- 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 efficacy or safety of the peptide vaccine.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Horizon Cancer Excellence Center, Bumrungrad International Hospital
Bangkok, 10110
Clinical Research Center, +662-011-4245, researchcenter@bumrungrad.com
About this study
Official title: A Phase Ib Clinical Study of Personalized Neoantigen Peptide Vaccines for Solid Tumors
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. The goal is to help the patient's immune system recognize and attack their cancer.
The study will enroll adult patients (20 years or older) who have solid tumors that meet specific stage-related criteria. These include advanced cancers that are resistant to prior treatments and early-stage cancers at high risk of recurrence, where there are no standard adjuvant therapies available.
Read more
Participants will receive:
- A personalized neoantigen peptide vaccine designed from the mutations in their tumor tissue.
- Poly-ICLC (Hiltonol), a substance that stimulates the immune system.
- An anti-PD-1 immune checkpoint inhibitor, a drug that helps the immune system stay active against cancer.
The vaccine and drugs will be given through multiple injections over several months. Blood samples and imaging will be used to monitor the immune response and how the cancer responds to treatment. Participants will be followed for up to 12 months.
This study does not include a placebo group. Every participant will receive the personalized vaccine along with the other therapies.
The primary objectives of this study are:
- To assess whether the treatment is safe and tolerable.
- To evaluate whether this approach helps control the cancer and can be combined with other standard treatments in the future.
- Conditions
- Solid Tumors, Advanced Cancer, Recurrent Cancer, Neoantigen-Specific Immunotherapy, Personalized Cancer Vaccine
- Being tested
- Personalized Neoantigen Peptide Vaccine
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Neoantigen Peptide VaccineBiological
This is a personalized cancer vaccine made of 10-20 synthetic long peptides derived from the unique mutations (neoantigens) found in a patient's tumor. Each vaccine is custom-formulated based on whole exome and RNA sequencing of tumor and normal tissue. The peptides are administered intramuscularly in combination with poly-ICLC (Hiltonol) as an adjuvant to enhance immune response. The intervention aims to induce T-cell responses against tumor-specific neoantigens. Vaccinations are given during priming and booster phases, with long-term follow-up and immune monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Neoantigen Peptide Vaccine + Poly-ICLC + Anti-PD-1 | Experimental | Not described Receives: Biological: Personalized Neoantigen Peptide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Number and severity of treatment-emergent adverse events, graded according to CTCAE v5.0, to evaluate the safety and tolerability of personalized neoantigen peptide vaccines in combination with poly-ICLC and an anti-PD-1 immune checkpoint inhibitor.
Measured: From first vaccination through 72 weeks
Secondary outcomes (1)
Objective Tumor Response Rate (ORR)
Proportion of participants achieving complete or partial response as assessed by RECIST v1.1 or mRECIST criteria.
Measured: Baseline to 72 weeks after initial vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Mar 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seqker Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bumrungrad International Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002203
- Sponsor's protocol ID
- SQK01-002
- Status last verified
- Jul 2026
- First submitted
- 23 May 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Study of Personalized Neoantigen Peptide Vaccines for Solid Tumors
- ClinicalTrials.gov ID
- NCT07002203
- Acronym / sponsor ID
- SQK01-002
- Conditions
- Solid Tumors, Advanced Cancer, Recurrent Cancer, Neoantigen-Specific Immunotherapy, Personalized Cancer Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Seqker Biosciences, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bumrungrad International Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The goal is to help the patient's immune system recognize and attack their cancer.
The study will enroll adult patients (20 years or older) who have solid tumors that meet specific stage-related criteria. These include advanced cancers that are resistant to prior treatments and early-stage cancers at high risk of recurrence, where there are no standard adjuvant therapies available.
Participants will receive:
- A personalized neoantigen peptide vaccine designed from the mutations in their tumor tissue.
- Poly-ICLC (Hiltonol), a substance that stimulates the immune system.
- An anti-PD-1 immune checkpoint inhibitor, a drug that helps the immune system stay active against cancer.
The vaccine and drugs will be given through multiple injections over several months. Blood samples and imaging will be used to monitor the immune response and how the cancer responds to treatment. Participants will be followed for up to 12 months.
This study does not include a placebo group. Every participant will receive the personalized vaccine along with the other therapies.
The primary objectives of this study are:
- To assess whether the treatment is safe and tolerable.
- To evaluate whether this approach helps control the cancer and can be combined with other standard treatments in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized Neoantigen Peptide Vaccine + Poly-ICLC + Anti-PD-1 | Experimental | Biological: Personalized Neoantigen Peptide Vaccine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Neoantigen Peptide VaccineThis is a personalized cancer vaccine made of 10-20 synthetic long peptides derived from the unique mutations (neoantigens) found in a patient's tumor. Each vaccine is custom-formulated based on whole exome and RNA sequencing of tumor and normal tissue. The peptides are administered intramuscularly in combination with poly-ICLC (Hiltonol) as an adjuvant to enhance immune response. The intervention aims to induce T-cell responses against tumor-specific neoantigens. Vaccinations are given during priming and booster phases, with long-term follow-up and immune monitoring. | Biological | Personalized Neoantigen Peptide Vaccine + Poly-ICLC + Anti-PD-1 |
Primary outcome
Incidence of Adverse Events
Time frame: From first vaccination through 72 weeks
Number and severity of treatment-emergent adverse events, graded according to CTCAE v5.0, to evaluate the safety and tolerability of personalized neoantigen peptide vaccines in combination with poly-ICLC and an anti-PD-1 immune checkpoint inhibitor.
1 secondary outcome
Objective Tumor Response Rate (ORR)
Time frame: Baseline to 72 weeks after initial vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Personalized Neoantigen Peptide Vaccine in people with Solid Tumors and Advanced Cancer, run by Seqker Biosciences, Inc. at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seqker Clinical Study Team (+6690-986-2498, clinical@seqker.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: From first vaccination through 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.