A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)
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.
Checked against the public recordLast updated Jun 16, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Clasp Therapeutics, Inc.
- Interventions being studied
- Drug: CLSP-5282
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 brain tumors, active central nervous system metastases and/or carcinomatous meningitis
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Duke Cancer InstituteDurham, North Carolina
- Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, Pennsylvania
- Sarah Cannon Research Institute (SCRI) Oncology PartnersNashville, Tennessee
- Mary Crowley Cancer ResearchDallas, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 16, 2026. Always confirm current availability with the study team.