A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Recruiting · NCT06778863 · Interventional (participants receive a specific treatment) · Lead sponsor: Clasp Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
CLSP-1025
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Key
Exclusion criteria
- Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation
- Patients who have received other p53 R175H-directed therapies
- Patients who have not fully recovered from adverse events due to previous anticancer therapies
- Patients with active infection requiring systemic antimicrobial therapy
- 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.
- Known active central nervous system metastases and/or carcinomatous meningitis
Where it is running
21 locations listed across 13 US states.
- HonorHealth Research Institute - Scottsdale, Arizona, United States
- The University of Arizona Cancer Center - Tucson, Arizona, United States
- USC - Norris Comprehensive Cancer Center - Los Angeles, California, United States
- University of California Davis Comprehensive Cancer Center - Sacramento, California, United States
- University of California San Francisco - San Francisco, California, United States
- University of Miami - Sylvester Comprehensive Cancer Center - Miami, Florida, United States
- The University of Chicago Comprehensive Cancer Center - Chicago, Illinois, United States
- University of Kentucky Markey Cancer Center - Lexington, Kentucky, United States
- Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland, United States
- Hackensack University Medical Center - Hackensack, New Jersey, United States
- NYU Langone Health - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Duke Cancer Institute - Durham, North Carolina, United States
- Thomas Jefferson University, Sidney Kimmel Cancer Center - Philadelphia, Pennsylvania, United States
- Fox Chase Cancer Center - Philadelphia, Pennsylvania, United States
- Sarah Cannon Research Institute (SCRI) Oncology Partners - Nashville, Tennessee, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- Mary Crowley Cancer Research - Dallas, Texas, United States
- Baylor University Medical Center - Dallas, Texas, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States