NCT07650357Not 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
Source: ClinicalTrials.gov · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- Jul 2026
- Primary completion date
- May 2029
- Lead sponsor
- Clasp Therapeutics, Inc.
- Diseases
- Lung cancer, Pancreatic cancer, Colorectal cancer
- NCT number
- NCT07650357
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 140
- From Jul 2026 to the primary completion date, May 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with active infection requiring systemic antimicrobial therapy
- Known primary malignant brain tumors, active central nervous system metastases and/or carcinomatous meningitis
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mary Crowley Cancer Research Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Sarah Cannon Research Institute (SCRI) Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Thomas Jefferson University, Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.