Volver a Ensayos Clínicos
NCT07650357
A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)
Traducción pendiente · disponible pronto
Aún no reclutando
Fase 1
Descripción
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.
Criterios de Elegibilidad
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
Información del Ensayo
NCT07650357
Aún no reclutando
Fase 1
140 participantes
Jul 2026
Ubicaciones4
United States (4)
Duke Cancer Institute
Durham, North Carolina, 27701
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Sarah Cannon Research Institute (SCRI) Oncology Partners
Nashville, Tennessee, 37203
Mary Crowley Cancer Research
Dallas, Texas, 75230