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Not Yet RecruitingPhase 1NCT07650357
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCLSP-5282

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Not Yet Recruiting

The study is not accepting participants yet.

What kind of study?Phase 1

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?Clasp Therapeutics, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Clasp Therapeutics, Inc.
Interventions being studied
Drug: CLSP-5282
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
KRAS→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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