Study of ABO2102 in KRAS-Mutated Solid Tumors
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumor Activity of ABO2102 in Participants With KRAS Mutant Solid Tumors
Suzhou Abogen Biosciences Co., Ltd.
101 participants
Mar 24, 2026
INTERVENTIONAL
Conditions
Summary
This is a multicenter, open-label Phase 1 clinical study to evaluate the safety, tolerability, immunogenicity, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics, as well as preliminary anti-tumor activity of ABO2102 as monotherapy and in combination among participants with solid tumors with KRAS mutations.
Eligibility
Inclusion Criteria6
- ≥18 years of age at time of informed consent.
- Have a genetically tested report confirmed by the investigator or complete genetic testing during the screening period, with evidence of harboring any of required KRAS mutations
- Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors.
- According to RECIST v1.1, at least one measurable lesion is required.
- No severe hematological, hepatic, renal or coagulation dysfunction; laboratory test results during the screening period must meet the respective criteria specified in the study protocol.
- Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception.
Exclusion Criteria10
- 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.
- Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy .
- Received KRAS cancer vaccine before.
- History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy.
- History of allogeneic organ transplantation or graft-versus-host disease (GVHD).
- Any active infection (except for hepatitis virus infection) requires systemic treatment.
- Absence of spleen
- Known psychiatric disorder or drug abuse that may interfere with the trial requirements
- Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study.
- Other conditions that Investigators consider inappropriate for enrollment.
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Interventions
mRNA encoding mutant KRAS neoantigens, administrated intramuscularly
Anti-PD-1 antibody, administered intravenously
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07455617