Actively Recruiting
Study of ABO2102 in KRAS-Mutated Solid Tumors
Led by Suzhou Abogen Biosciences Co., Ltd. · Updated on 2026-04-06
101
Participants Needed
1
Research Sites
201 weeks
Total Duration
On this page
Sponsors
S
Suzhou Abogen Biosciences Co., Ltd.
Lead Sponsor
A
Abogen Biosciences (Shanghai) Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of ABO2102 in KRAS-Mutated Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at time of informed consent
- Genetically confirmed KRAS mutation by investigator or during screening
- Histopathologically and/or cytologically confirmed locally advanced or metastatic solid tumors
- At least one measurable lesion according to RECIST v1.1
- No severe blood, liver, kidney, or coagulation dysfunction per lab tests during screening
- Females of childbearing potential and males with heterosexual activity agree to use highly effective contraception
You will not qualify if you...
- Other prior active malignancy within past 5 years except cured skin basal cell cancer, superficial bladder cancer, or carcinoma in situ of breast or cervix
- Known symptomatic central nervous system metastases or requiring CNS-directed therapy
- Prior receipt of KRAS cancer vaccine
- History of severe (Grade 3 or higher) hypersensitivity to immunotherapy
- History of allogeneic organ transplant or graft-versus-host disease
- Active infection requiring systemic treatment (except hepatitis virus infection)
- Absence of spleen
- Known psychiatric disorder or drug abuse interfering with study
- Pregnant, breastfeeding, or planning to conceive during study
- Other conditions deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Actively Recruiting
Research Team
X
Xiao Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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