Clinical Trials in the USA / NCT06778863
Recruiting
Phase 1
A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
NCT06778863 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Advanced Solid TumorUnresectable Solid TumorMetastatic Solid TumorColorectal AdenocarcinomaPancreatic AdenocarcinomaLung CancerOvarian CancerBreast CancerHead and Neck Squamous Cell CarcinomaProstate CancerBladder Cancer
Investigational drug(s) / intervention(s)
CLSP-1025
CLSP-1025: CLSP-1025 will be administered by IV infusion
Study summary
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.
Eligibility
Key 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
Primary outcome measure(s)
- Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s]) — 28 days after infusion
Rate of dose-limiting toxicities (DLTs) after infusion of CLSP-1025 - Part B: Evaluate the Objective response rate (ORR) of CLSP-1025 as a monotherapy in HLA-selected patients with advanced solid tumors that express the p53 R175H mutation — Up to 24 months after infusion
Objective response rate (ORR) per RECIST V1.1 determined by Investigator assessment
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | Recruiting |
| The University of Arizona Cancer Center | Tucson | Arizona | Recruiting |
| USC - Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | Recruiting |
| University of California San Francisco | San Francisco | California | Recruiting |
| University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida | Recruiting |
| The University of Chicago Comprehensive Cancer Center | Chicago | Illinois | Recruiting |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | Recruiting |
| Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Duke Cancer Institute | Durham | North Carolina | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| Sarah Cannon Research Institute (SCRI) Oncology Partners | Nashville | Tennessee | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| Mary Crowley Cancer Research | Dallas | Texas | Recruiting |
| Baylor University Medical Center | Dallas | Texas | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06778863 on ClinicalTrials.gov ↗ ← All trials in the USA