A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101) (NCT07650357) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)
United States140 participantsStarted 2026-07
Plain-language summary
Phase 1, open-label, multicenter study to evaluate the safety, tolerability, PK, PD, and preliminary clinical activity of CLSP 5282 when administered to HLA A\*03:01-positive adult patients with advanced solid tumors that harbor the KRas G12V mutation.
Who can participate
Age range
18 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:
* Adults at least 18 years of age on the day of signing informed consent.
* Willing and able to provide written informed consent for the study.
* Histologically or cytologically diagnosed, locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists.
* Tumors must harbor the KRas G12V mutation confirmed by the site's local or preferred tissue or ctDNA testing platform in an accredited laboratory.
* Patients must be HLA-A\*03:01 positive by central assay.
* Eastern Cooperative Oncology Group performance status of 0 or 1.
* Adequate hematological, renal and hepatic function.
* Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation.
Exclusion Criteria:
* Patients who have received other KRas G12V directed cellular therapies or TCEs.
* Patients may not be on other anticancer therapies at the time of the first dose of CLSP-5282. Exceptions upon agreement with Sponsor.
* Any other primary malignancy within the 2 years prior to first dose of study treatment except for non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, breast), or prostate cancer in remission.
* Patients who have not fully recovered from adverse events due to previous anticancer therapies
* Patients with active infection requiring systemic antimicrobial therapy
* Known primary malignant…
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.
1This trial is called SENTINEL-101 and it's specifically for people who test positive for HLA-A*03:01 — do I have that genetic marker, and if not, is there any point in exploring this study further?
2Since this is a Phase 1 trial focused on dose escalation, meaning researchers are still working out safe dosing levels, how does that early-stage uncertainty compare to the safety and benefit data we already have for my standard treatment options for my specific cancer type?
3The trial isn't recruiting yet — given where my cancer is right now, does my doctor think it's realistic to wait for this study to open, or would starting another treatment sooner make more sense for my situation?
4This study covers several different cancer types including non-small cell lung cancer, pancreatic cancer, and colorectal cancer — does my specific diagnosis and how advanced it is seem like a reasonable fit for what this trial is targeting, based on what my doctor knows about CLSP 5282?
5Since Part A involves dose escalation where early participants may receive lower, potentially less active doses while safety is being established, is my doctor aware of any interim signals from the sponsor or related research that might give us a sense of what to expect?
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.