Pancreatic NeoplasmsEarly Phase 1NCT06577532
Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors
A Early Phase 1 study testing ABO2102 and Toripalimab in people with Pancreatic Neoplasms and Other Solid Tumors, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Other Solid Tumors
- What is being tested?
- ABO2102 and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2024to Aug 2027
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age at time of informed consent.
- Participants with histologically and/ or cytologically confirmed advanced solid tumors (such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, etc.), whose disease has progressed or being intolerant to relevant treatments during or following at least one line of systemic treatment; patients in the second stage include those who have experienced disease progression or intolerance to previous systemic treatments, as well as those who have not received systemic therapy but are deemed by the investigator to potentially benefit from the study treatment based on a comprehensive clinical assessment.
- Harboring at least one of the targeted KRAS mutants.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0~2.
- Life expectancy of ≥12 weeks.
- Sufficient organ function.
Who cannot join
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.
- Received KRAS cancer vaccine before.
- Immunosuppressants or other immunomodulatory drugs were required within 4 weeks before the first dose of study treatment. Physiological doses of systemic steroids or topical medications are allowed. Topical medications should not exceed the dose recommended in the package insert or have any systemic exposure signs; Or patients with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation who need to use immunosuppressants or other immunomodulatory drugs.
- History of severe allergies or known allergies to any active or inactive component of the study drug(s).
- Uncontrolled systemic infection; active tuberculosis.
- Severe cardiovascular diseases.
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- Has known symptomatic, untreated central nervous system metastases, or CNS metastases requiring continued treatment. Participants with asymptomatic brain metastases and who do not require treatment are eligible for enrolment.
- Have active autoimmune and inflammatory diseases.
- Have immediate hypersensitivity, a history of eczema or asthma uncontrolled by topical corticosteroids.
- Have other serious medical conditions
- A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai
Baiyong Shen
About this study
Official title: A Clinical Study to Investigate Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of mRNA Nanoparticles Encoding KRAS Neoantigens (ABO2102) in Participants With KRAS-mutated Advanced Pancreatic Cancer And Other Solid Tumors
The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.
- Conditions
- Pancreatic Neoplasms, Other Solid Tumors
- Being tested
- ABO2102, Toripalimab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABO2102Drug
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
ToripalimabDrug
Anti-PD-1 antibody, administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| ABO2102 | Experimental | Prat I: Monotherapy Receives: Drug: ABO2102 |
| ABO2102 and Toripalimab | Experimental | Part I\&II: ABO2102 in combination with Toripalimab Receives: Drug: ABO2102; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I: The incidence and nature of dose-limiting toxicity (DLT) for ABO2102 as monotherapy or in combination with toripalilmab.
Measured: 21 days after the first dose of study treatment
Part I: The incidence and severity of treatment-emergent adverse events (TEAE)s.
Measured: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part I: The incidence and severity of serious TEAEs (TESAE)s.
Measured: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part I: The incidence and severity of TEAEs leading to interruption or early termination of study treatment.
Measured: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part II: Overall Response Rate (ORR) per RECIST version 1.1.
Measured: from the first dose of study treatment to up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start24 Sep 2024
- Primary completionDec 2026 (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 Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Abogen Biosciences Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Baiyong Shen, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577532
- Sponsor's protocol ID
- ABO2102-001
- Status last verified
- May 2025
- First submitted
- 22 Aug 2024
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate Safety, Tolerability, Immunogenicity, and Preliminary Efficacy of mRNA Nanoparticles Encoding KRAS Neoantigens (ABO2102) in Participants With KRAS-mutated Advanced Pancreatic Cancer And Other Solid Tumors
- ClinicalTrials.gov ID
- NCT06577532
- Acronym / sponsor ID
- ABO2102-001
- Conditions
- Pancreatic Neoplasms, Other Solid Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Suzhou Abogen Biosciences Co., Ltd.
- Study start
- 24 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 29 Aug 2024 (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.
The purpose of this study is to evaluate the safety, immunogenicity, pharmacodynamics, as well as preliminary efficacy of KRAS neoantigen mRNA vaccine (ABO2102) alone and in combination with toripalimab (anti-PD-1 monoclonal antibody) among participants with KRAS-mutated advanced pancreatic cancer and other solid tumors. The trial includes dose escalation (Part I) and dose expansion(Part II) parts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABO2102 | Experimental | Drug: ABO2102Prat I: Monotherapy |
| ABO2102 and Toripalimab | Experimental | Drug: ABO2102, Drug: ToripalimabPart I\&II: ABO2102 in combination with Toripalimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years of age at time of informed consent.
- Participants with histologically and/ or cytologically confirmed advanced solid tumors (such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, etc.), whose disease has progressed or being intolerant to relevant treatments during or following at least one line of systemic treatment; patients in the second stage include those who have experienced disease progression or intolerance to previous systemic treatments, as well as those who have not received systemic therapy but are deemed by the investigator to potentially benefit from the study treatment based on a comprehensive clinical assessment.
- Harboring at least one of the targeted KRAS mutants.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0~2.
- Life expectancy of ≥12 weeks.
Key exclusion criteria (11 listed)
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that have been cured, superficial bladder cancer, or carcinoma in situ of the breast or cervix.
- Received KRAS cancer vaccine before.
- Immunosuppressants or other immunomodulatory drugs were required within 4 weeks before the first dose of study treatment. Physiological doses of systemic steroids or topical medications are allowed. Topical medications should not exceed the dose recommended in the package insert or have any systemic exposure signs; Or patients with other acquired or congenital immunodeficiency diseases, or a history of organ transplantation who need to use immunosuppressants or other immunomodulatory drugs.
- History of severe allergies or known allergies to any active or inactive component of the study drug(s).
- Uncontrolled systemic infection; active tuberculosis.
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 |
|---|---|---|
| ABO2102mRNA encoding mutant KRAS neoantigens, administrated intramuscularly | Drug | ABO2102, ABO2102 and Toripalimab |
| ToripalimabAnti-PD-1 antibody, administered intravenously | Drug | ABO2102 and Toripalimab |
Primary outcome
Part I: The incidence and nature of dose-limiting toxicity (DLT) for ABO2102 as monotherapy or in combination with toripalilmab.
Time frame: 21 days after the first dose of study treatment
Part I: The incidence and severity of treatment-emergent adverse events (TEAE)s.
Time frame: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part I: The incidence and severity of serious TEAEs (TESAE)s.
Time frame: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part I: The incidence and severity of TEAEs leading to interruption or early termination of study treatment.
Time frame: from the first dose of study treatment to 30 days after the last dose of monotherapy or to 90 days after the last dose of the combination therapy.
Part II: Overall Response Rate (ORR) per RECIST version 1.1.
Time frame: from the first dose of study treatment to up to 2 years.
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 21 May 2025.
- Individual participant dataSharing planned: No
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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.
Baiyong Shen principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ABO2102 and Toripalimab in people with Pancreatic Neoplasms and Other Solid Tumors, run by Ruijin Hospital at 1 site in China.
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 6 inclusion and 11 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 21 May 2025. 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 China. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Xinjing Wang (18817821319, newvista89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part I: The incidence and nature of dose-limiting toxicity (DLT) for ABO2102 as monotherapy or in combination with toripalilmab. (time frame: 21 days after the first dose of study treatment). The study lists 5 primary outcomes in all. 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 21 May 2025.