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

Shanghai Jiao Tong University

Status and phase: Enrolling; Early Phase 1

Conditions: Other Solid Tumors; Pancreatic Neoplasms

Treatments: Drug: ABO2102; Drug: Toripalimab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06577532

ABO2102-001

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

ABO2102

Experimental group

Description:

Prat I: Monotherapy

Treatment:

Drug: ABO2102

ABO2102 and Toripalimab

Experimental group

Description:

Part I\&II: ABO2102 in combination with Toripalimab

Treatment:

Drug: Toripalimab

Drug: ABO2102