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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.
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

Full criteria on ClinicalTrials.gov

Sites (21)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
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BaltimoreUnited StatesRecruiting
The University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesRecruiting
Baylor University Medical Center
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DallasUnited StatesRecruiting
Mary Crowley Cancer Research
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DallasUnited StatesRecruiting
Duke Cancer Institute
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DurhamUnited StatesRecruiting
Hackensack University Medical Center
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HackensackUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
University of Miami - Sylvester Comprehensive Cancer Center
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MiamiUnited StatesRecruiting
Vanderbilt University Medical Center
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NashvilleUnited StatesRecruiting
Sarah Cannon Research Institute (SCRI) Oncology Partners
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NashvilleUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
NYU Langone Health
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New YorkUnited StatesRecruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center
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PhiladelphiaUnited StatesRecruiting
Fox Chase Cancer Center
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PhiladelphiaUnited StatesRecruiting
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesRecruiting
University of California San Francisco
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San FranciscoUnited StatesRecruiting
HonorHealth Research Institute
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ScottsdaleUnited StatesRecruiting
Fred Hutchinson Cancer Center
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SeattleUnited StatesRecruiting
The University of Arizona Cancer Center
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TucsonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.