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Study of CLSP-5282 for Advanced Solid Tumors

This study is testing a drug called CLSP-5282 for adults with advanced solid tumors, including non-small cell lung cancer, pancreatic cancer, and colorectal cancer. These tumors must have gotten worse after standard treatments or have no standard treatment options. To join, you must be at least 18 years old and have a specific genetic marker called HLA-A*03:01, and your tumor must have a KRAS G12V mutation. The study aims to find out how safe CLSP-5282 is, how well your body handles it, and if it shows any signs of shrinking tumors. The study's success will be measured by how patients respond to the treatment, with some assessments happening after 28 days and others up to 24 months. The current recruitment status is unclear.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll 140 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure responses at 28 days after infusion and for up to 24 months after infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07650357

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Clasp Therapeutics, Inc.
~140 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:CLSP-5282

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A Monotherapy Dose Escalation
Measured over 28 days after infusion
+1 more outcome measured

Conditions

Advanced Solid Tumor
Non Small Cell Lung Cancer
Pancreatic Carcinoma
Colorectal Cancer

Explore related trials

Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic CarcinomaSolid NeoplasmGTPase KRasHLA-A Gene

Where it's being run

4 sites across 4 states
North Carolina1
Pennsylvania1
Tennessee1
Texas1

Study leadership

  • Lauren Harshman, MD · STUDY_DIRECTOR · Clasp Therapeutics

Who to contact

Lauren Harshman, MD
[email protected]
+1-617-812-1431
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Part A Monotherapy Dose Escalation28 days after infusion

    To characterize the safety and tolerability of CLSP-5282 and to determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE\[s\]).

  • Part B Monotherapy ExpansionUp to 24 months after infusion

    To evaluate the preliminary antitumor activity of CLSP-5282