NCT06778863RecruitingPhase 1
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- 28 Feb 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Clasp Therapeutics, Inc.
- Diseases
- Prostate cancer, Head and neck cancer, Bladder cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Ovarian cancer
- NCT number
- NCT06778863
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 90
- From 28 Feb 2025 to the primary completion date, Dec 2027
- 21 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 p53 R175H-directed therapies
- Patients who have not fully recovered from adverse events due to previous anticancer therapies
- Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission.
Other illness
- Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation
- Patients with active infection requiring systemic antimicrobial therapy
Other
- Known active central nervous system metastases and/or carcinomatous meningitis
Who the study is looking for
- Patients must be at least 18 years of age at the time of signing the informed consent.
- Patients must be willing and able to provide written informed consent
- Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists
- Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test
- Patients must be HLA-A\*02:01 positive by central assay
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment
- 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 (21)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| The University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Baylor University Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Mary Crowley Cancer Research Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| University of Miami - Sylvester Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Sarah Cannon Research Institute (SCRI) Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| HonorHealth Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Recruiting |
| Fred Hutchinson Cancer Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| The University of Arizona Cancer Center Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.