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Not yet recruitingPhase 1

A Study of CLSP 5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors (SENTINEL-101)

SENTINEL-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-5282 in HLA-A*03:01 Positive Adult Patients With Solid Tumors That Harbor the KRas G12V Mutation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests the safety and effects of CLSP 5282 and how the body handles it. It is for adults with advanced solid tumors that have a gene change called KRas G12V and a marker called HLA-A*03:01.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are at least 18 years old when signing the consent form.
  • Are willing and able to give written consent to join.
  • Have a solid tumor confirmed by tissue or cell testing that has grown nearby or spread. It must have worsened after standard treatment, or have no standard treatment available.
  • Have a tumor with the KRas G12V gene change, confirmed by an approved lab using tumor tissue or blood testing.
  • Have the HLA-A*03:01 marker, confirmed by the study's central lab.
  • Can do normal daily activities, though hard physical activity may be limited.
  • Have blood counts, kidneys, and liver that work well enough for the study.
  • Are willing and able to follow study rules and complete visits and tests, as judged by the study doctor.

Who can't join

  • Have received cell treatments or T-cell engagers—treatments that help immune cells target cancer—aimed at KRas G12V.
  • Are taking other cancer treatments when receiving the first CLSP 5282 dose, unless the study sponsor agrees to an exception.
  • Have had another separate cancer within the past 2 years. Exceptions include non-melanoma skin cancer, cancer that has stayed where it began, or prostate cancer in remission.
  • Have not fully recovered from side effects of past cancer treatments.
  • Have an active infection that needs medicine that works throughout the body.
  • Have a cancer that started in the brain, active cancer spread to the brain or spinal cord, or cancer in their lining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (4)

NC

PA

TN

TX