CancerPhase 1/2NCT05741242
A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
A Phase 1/2 study testing Personalized Synthetic Long Peptide Vaccine in people with Cancer and Solid Tumor, run by Jaime Leandro Foundation for Therapeutic Cancer Vaccines at 6 sites in United States.
Trial summary
A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cancer, Solid Tumor
- What is being tested?
- Personalized Synthetic Long Peptide Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Nov 2022to Jan 2029
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine.
- Intercurrent illness requiring chronic use of medications that may interfere with rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune response to vaccine treatment (immunosuppressive therapies).
- Psychiatric illness or social situations that would limit compliance with study requirements.
- History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine.
- Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test.
- Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
- Male subjects with a female partner of childbearing potential must agree to practice abstinence or to use a physician-approved contraceptive method throughout the study and for 3 months following the last dose of study drug.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Precision NextGen Oncology & Research Center
Beverly Hills, California, 90212
St. Louis Cancer Care
Bridgeton, Missouri, 63044
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Anna Gattani MD PC
New York, New York, 10028
Quest Clinical Research
San Francisco, California, 94115
Asthra Health
Santa Monica, California, 90403
About this study
A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
Read the detailed description
This is a Simon-two stage multi-cohort study to assess the safety and efficacy of neoantigen synthetic long peptide vaccines in patients with local or metastatic solid tumors.
- To assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12).
- To assess efficacy of NeoSLP vaccination by assessment of Time to Treatment Failure (TTF).
- To assess efficacy of NeoSLP vaccination by assessment of Overall Survival at 24 months (OS24).
- To investigate the immunogenicity of NeoSLP vaccines by ELISpot assay. 5. To assess the safety and tolerability of NeoSLP vaccines.
- Conditions
- Cancer, Solid Tumor
- Being tested
- Personalized Synthetic Long Peptide Vaccine
- Keywords
- personalized neoantigen vaccine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Synthetic Long Peptide VaccineBiological
Personalized Synthetic Long Peptide Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Personalized Synthetic Long Peptide Vaccine | Experimental | Not described Receives: Biological: Personalized Synthetic Long Peptide Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12).
Progression-Free Survival at 12 months (PFS12) defined as time from first vaccine administration until disease progression by investigator assessment or death due to any cause.
Measured: Until progression or death, assessed up to 12 months post first vaccine administration.
Secondary outcomes (3)
To assess efficacy of NeoSLP vaccination by assessment of Time to Treatment Failure (TTF).
Time to Treatment Failure (TTF) is defined as time from first vaccine administration to discontinuation of treatment due to any reason, including disease progression, treatment toxicity, and death.
Measured: Assessed up to 12 months post first vaccine administration
To assess efficacy of NeoSLP vaccination by assessment of Overall Survival at 24 months (OS24).
Overall Survival at 24 months (OS24) is the landmark of OS defined as the proportion of patients alive at 24 months.
Measured: Until death, assessed up to 24 months post first vaccine administration
To assess the safety and tolerability of NeoSLP vaccines.
Adverse Events (AEs) and Severe Adverse Events (SAEs)
Measured: Assessed up to 60 days from last vaccine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start30 Nov 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaime Leandro Foundation for Therapeutic Cancer Vaccines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741242
- Sponsor's protocol ID
- JLF-200
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05741242
- Acronym / sponsor ID
- JLF-200
- Conditions
- Cancer, Solid Tumor
- Keywords
- personalized neoantigen vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Jaime Leandro Foundation for Therapeutic Cancer VaccinesUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 23 Feb 2023 (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.
A Phase 1b/2, Multi-center, Single Arm Study to Assess the Safety and Efficacy of Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
Detailed description
This is a Simon-two stage multi-cohort study to assess the safety and efficacy of neoantigen synthetic long peptide vaccines in patients with local or metastatic solid tumors.
- To assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12).
- To assess efficacy of NeoSLP vaccination by assessment of Time to Treatment Failure (TTF).
- To assess efficacy of NeoSLP vaccination by assessment of Overall Survival at 24 months (OS24).
- To investigate the immunogenicity of NeoSLP vaccines by ELISpot assay. 5. To assess the safety and tolerability of NeoSLP vaccines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized Synthetic Long Peptide Vaccine | Experimental | Biological: Personalized Synthetic Long Peptide Vaccine |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine.
- Intercurrent illness requiring chronic use of medications that may interfere with rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune response to vaccine treatment (immunosuppressive therapies).
- Psychiatric illness or social situations that would limit compliance with study requirements.
- History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine.
- Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test.
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 Synthetic Long Peptide VaccinePersonalized Synthetic Long Peptide Vaccine | Biological | Personalized Synthetic Long Peptide Vaccine |
Primary outcome
To assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12).
Time frame: Until progression or death, assessed up to 12 months post first vaccine administration.
Progression-Free Survival at 12 months (PFS12) defined as time from first vaccine administration until disease progression by investigator assessment or death due to any cause.
3 secondary outcomes
To assess efficacy of NeoSLP vaccination by assessment of Time to Treatment Failure (TTF).
Time frame: Assessed up to 12 months post first vaccine administration
To assess efficacy of NeoSLP vaccination by assessment of Overall Survival at 24 months (OS24).
Time frame: Until death, assessed up to 24 months post first vaccine administration
To assess the safety and tolerability of NeoSLP vaccines.
Time frame: Assessed up to 60 days from last vaccine administration
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 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites 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 Synthetic Long Peptide Vaccine in people with Cancer and Solid Tumor, run by Jaime Leandro Foundation for Therapeutic Cancer Vaccines at 6 sites in United States.
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 0 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of NeoSLP vaccination by investigator assessment of Progression-Free Survival at 12 months (PFS12). (time frame: Until progression or death, assessed up to 12 months post first vaccine administration.). 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 29 Sep 2026.