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Luciann Nguyen
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NCT07455617phase 1recruiting

Study of ABO2102 in KRAS-Mutated Solid Tumors

Suzhou Abogen Biosciences Co., Ltd. · with Abogen Biosciences (Shanghai) Co., Ltd

ClinicalTrials.gov
101
Enrollment · estimated
1
Countries · 1 sites
2029-06
Primary completion
5 mo ago
Record updated
Commercial relevance

No explicit biomarker / molecular-testing language identified in the public record.

Biomarker requirement language
  • 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.
Change timeline

No changes detected yet. The first refresh records a baseline snapshot; subsequent refreshes generate field-level changes.

Signals from this trial
  • New trial
    42/100
    Opportunity

    New phase 1 trial NCT07455617 posted by Suzhou Abogen Biosciences Co., Ltd.: "Study of ABO2102 in KRAS-Mutated Solid Tumors".

    ClinicalTrials.gov record updated 155 days ago.

Eligibility — raw, for validation
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.