NCT07455617 Study of ABO2102 in KRAS-Mutated Solid Tumors
| NCT ID | NCT07455617 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Suzhou Abogen Biosciences Co., Ltd. |
| Condition | Advanced / Metastatic Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 101 participants |
| Start Date | 2026-03-24 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 101 participants in total. It began in 2026-03-24 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07455617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced / Metastatic Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07455617 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07455617 currently recruiting?
Yes, NCT07455617 is actively recruiting participants. Contact the research team at xiao.zhang@abogenbio.com for enrollment information.
Where is the NCT07455617 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07455617 clinical trial?
NCT07455617 is sponsored by Suzhou Abogen Biosciences Co., Ltd.. The trial plans to enroll 101 participants.