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NCT Number: NCT07455617

Study of ABO2102 in KRAS-Mutated Solid Tumors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Baiyong Shen

PRINCIPAL_INVESTIGATOR

Xinjing Wang

CONTACT

[email protected]

8618817821319

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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 criteria

  • 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.

Treatment and study plan

ABO2102 Injection

Drug

mRNA encoding mutant KRAS neoantigens, administrated intramuscularly

Sintilimab Injection

Drug

Anti-PD-1 antibody, administered intravenously

Primary outcomes

  1. Part I: dose-limiting toxicities (DLT) with ABO2102 as monotherapy and in combination with Sintilimab

    Time frame: 28 days after the first dose of study treatment

  2. Part I: Incidence and severity of adverse events

    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 II: ORR evaluated by investigators according to RECIST v1.1 criteria

    Time frame: from the first dose of study treatment to up to 3 years

  4. Part II: PFS evaluated by investigators according to RECIST v1.1 criteria

    Time frame: from the first dose of study treatment to up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Zhang

CONTACT

[email protected]

8619931100148

Sponsors and collaborators

Lead sponsor

Suzhou Abogen Biosciences Co., Ltd.

Industry

Collaborators

  • Abogen Biosciences (Shanghai) Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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