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Recruiting Phase 1

Study of ABO2102 in KRAS-Mutated Solid Tumors

NCT07455617 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2026-03-24
Last updated
2026-04-06

Condition(s) studied

Advanced / Metastatic Solid Tumor

Investigational drug(s) / intervention(s)

ABO2102 Injection →Sintilimab injection →

ABO2102 Injection: mRNA encoding mutant KRAS neoantigens, administrated intramuscularly

Sintilimab injection: Anti-PD-1 antibody, administered intravenously

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. ≥18 years of age at time of informed consent. 2. 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 3. Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors. 4. According to RECIST v1.1, at least one measurable lesion is required. 5. 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. 6. Females of childbearing potential and males who are involved in heterosexual activity must agree to practice highly effective contraception. 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. Has known symptomatic central nervous system (CNS) metastases, or CNS metastases requiring local CNS-directed therapy . 3. Received KRAS cancer vaccine before. 4. History of severe (≥ Grade 3) hypersensitivity reactions to immunotherapy. 5. History of allogeneic organ transplantation or graft-versus-host disease (GVHD). 6. Any active infection (except for hepatitis virus infection) requires systemic treatment. 7. Absence of spleen 8. Known psychiatric disorder or drug abuse that may interfere with the trial requirements 9. Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. 10. Other conditions that Investigators consider inappropriate for enrollment.

Primary outcome measure(s)

  • Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab — 28 days after the first dose of study treatment
  • Part I: Incidence and severity of adverse events — 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: ORR evaluated by investigators according to RECIST v1.1 criteria — from the first dose of study treatment to up to 3 years
  • Part II: PFS evaluated by investigators according to RECIST v1.1 criteria — from the first dose of study treatment to up to 3 years

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07455617 on ClinicalTrials.gov ↗ ← All trials in China