Study of KRAS-Specific Vaccine in Patients With KRAS-Mutated Solid Tumors (NCT07396090) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of KRAS-Specific Vaccine in Patients With KRAS-Mutated Solid Tumors
13 participantsStarted 2026-01-20
Plain-language summary
The purpose of this study is to evaluate the safety, immunogenicity and preliminary efficacy of engineered dendritic cells(eDCs)loaded with mKRAS antigen (CAT-101) alone or in combination with Tislelizumab (anti-PD-1 monoclonal antibody) among participants with KRAS-G12C/D/R/V mutated advanced pancreatic cancer and other solid tumors.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:(1)Age 18-75 years,Male or female ; (2)Participants with ECOG score of 0-1 and the life expectancy ≥6 months; (3)Sufficient organ function as defined by the following criteria: creatinine clearance of ≥45 mL/min;Serum AST and serum ALT, ≤3.0 x ULN (≤5 x ULN for patients with liver metastases); Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0 × ULN (except for congenital hyperbilirubinemia, such as Gilbert syndrome, the direct bilirubin may be ≤1.5 × ULN); for patients with liver and/or bone metastases, alkaline phosphatase ≤5.0 × ULN; Left ventricular ejection fraction ≥45% (by echocardiography or MUGA) (4) pregnancy test for women must be negative, and or must not be breastfeeding; participants with childbearing potential must agree to use effective contraception from the signing of the informed consent form until 1 year after the use of the study drug; (5) Willing to sign the informed consent form (ICF); (6)HLA-A\*1101+ Participants with histologically confirmed advanced solid tumors (such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, etc.) and harboring at least one of the targeted KRAS mutants (G12C/D/R/V); (7)Participants who have failed standard treatment or who have no standard treatment options or who have minimal residual disease (MRD) after standard treatment , as well as those have unresectable locally advanced or metastatic solid tumors but currently unsuitable for standard treatment.
(8) Participants must ha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse events
Timeframe: up to 24 months
Trial details
NCT IDNCT07396090
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences