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

ConditionsPancreatic NeoplasmsOther Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • ABO2102

    Drug

    mRNA encoding mutant KRAS neoantigens, administrated intramuscularly

  • Toripalimab

    Drug

    Anti-PD-1 antibody, administered intravenously

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: ABO2102Experimental treatment 1 intervention
Group B: ABO2102 and ToripalimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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.
3

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.
4

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Suzhou Abogen Biosciences Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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