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Study of ABO2102 in KRAS-Mutated Solid Tumors

ConditionAdvanced / Metastatic Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Abogen Biosciences Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≥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.

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.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ABO2102 Injection

    Drug

    mRNA encoding mutant KRAS neoantigens, administrated intramuscularly

  • Sintilimab injection

    Drug

    Anti-PD-1 antibody, administered intravenously

Treatment groups

101 Participants
are divided into 2 treatment groups
Group A: ABO2102 InjectionExperimental treatment 1 intervention
Group B: ABO2102 Injection and Sintilimab InjectionExperimental treatment 2 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Suzhou Abogen Biosciences Co., Ltd.

Lead sponsor

Abogen Biosciences (Shanghai) Co., Ltd

Collaborator

Source ClinicalTrials.gov
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