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Clinical Trial Record

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Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated Solid Tumors

2024-09-24

2026-12

2027-08

56

Study Overview

Study of KRAS Neoantigen mRNA Vaccine (ABO2102) in Patients With KRAS -Mutated 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.

N/A

  • Pancreatic Neoplasms
  • Other Solid Tumors
  • DRUG: ABO2102
  • DRUG: Toripalimab
  • ABO2102-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-08-22  

N/A  

2025-05-18  

2024-08-27  

N/A  

2025-05-21  

2024-08-29  

N/A  

2025-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: ABO2102

Prat I: Monotherapy

DRUG: ABO2102

  • mRNA encoding mutant KRAS neoantigens, administrated intramuscularly

DRUG: Toripalimab

  • Anti-PD-1 antibody, administered intravenously
EXPERIMENTAL: ABO2102 and Toripalimab

Part I&II: ABO2102 in combination with Toripalimab

DRUG: ABO2102

  • mRNA encoding mutant KRAS neoantigens, administrated intramuscularly

DRUG: Toripalimab

  • Anti-PD-1 antibody, administered intravenously
Primary Outcome MeasuresMeasure DescriptionTime Frame
Part I: The incidence and nature of dose-limiting toxicity (DLT) for ABO2102 as monotherapy or in combination with toripalilmab.21 days after the first dose of study treatment
Part I: The incidence and severity of treatment-emergent adverse events (TEAE)s.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.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.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.from the first dose of study treatment to up to 2 years.
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xinjing Wang

Phone Number: 18817821319

Email: newvista89@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. ≥18 years of age at time of informed consent. 2. 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. 3. Harboring at least one of the targeted KRAS mutants. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0~2. 5. Life expectancy of ≥12 weeks. 6. Sufficient organ function.
    Exclusion Criteria:
    1. 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. 2. Received KRAS cancer vaccine before. 3. 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. 4. History of severe allergies or known allergies to any active or inactive component of the study drug(s). 5. Uncontrolled systemic infection; active tuberculosis. 6. Severe cardiovascular diseases. 7. 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. 8. Have active autoimmune and inflammatory diseases. 9. Have immediate hypersensitivity, a history of eczema or asthma uncontrolled by topical corticosteroids. 10. Have other serious medical conditions 11. A history of organ transplantation, bone marrow transplantation or hematopoietic stem cell transplantation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • Suzhou Abogen Biosciences Co., Ltd.
  • PRINCIPAL_INVESTIGATOR: Baiyong Shen, Ruijin Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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