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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This Phase 1 study tests different doses of CLSP-1025, a drug designed to help immune cells target cancer. It is for adults with solid tumors that have a gene change called p53 R175H and an immune system marker called HLA-A*02:01.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old when signing the consent form.
- Be willing and able to give written consent to join.
- Have a solid tumor that has spread nearby or to other parts of the body and has worsened after standard treatment, or has no standard treatment.
- Have a tumor with the TP53 R175H gene change, confirmed by an approved lab test.
- Test positive for the HLA-A*02:01 immune system marker through the study's central lab.
- Be fully active or able to do light work despite limits on hard physical activity.
- Have blood counts, kidney function, and liver function that meet study requirements.
- Be willing and able to follow study rules and complete visits and tests, as judged by the study doctor.
Who can't join
- Have Li-Fraumeni syndrome, an inherited condition that raises cancer risk, or another known inherited p53 R175H gene change.
- Have received another treatment aimed at p53 R175H.
- Have not fully recovered from side effects of past cancer treatments.
- Have an active infection that needs medicine that works throughout the body.
- Have had another separate cancer in the past 2 years, except non-melanoma skin cancer, cancer limited to where it started, or prostate cancer in remission.
- Have known active cancer spread to the brain or spinal cord, or cancer in the tissues covering them.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (21)
AZ
- HonorHealth Research Institute · Scottsdale, AZ 85258 · Study contact · 833-354-6667More trials in Scottsdale
- The University of Arizona Cancer Center · Tucson, AZ 85719 · Study contact · UACC-ClinicalTrialsInfo@arizona.eduMore trials in Tucson
CA
- USC - Norris Comprehensive Cancer Center · Los Angeles, CA 90033 · Study contact · 323-865-0451 · clinical.trials@med.usc.eduMore trials in Los Angeles
- University of California Davis Comprehensive Cancer Center · Sacramento, CA 95817 · Study contact · 916-703-5558More trials in Sacramento
- University of California San Francisco · San Francisco, CA 94143 · Study contact · hdfccc.cip@ucsf.eduMore trials in San Francisco
FL
- University of Miami - Sylvester Comprehensive Cancer Center · Miami, FL 33136 · Study contact · 407-765-9589More trials in Miami
IL
- The University of Chicago Comprehensive Cancer Center · Chicago, IL 60637 · Study contact · 855-403-0533More trials in Chicago
KY
- University of Kentucky Markey Cancer Center · Lexington, KY 40536 · Study contact · 859-257-4488More trials in Lexington
MD
- Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center · Baltimore, MD 21287 · Study contact · 410-955-8964More trials in Baltimore
NC
- Duke Cancer Institute · Durham, NC 27701 · Study contact · 866-385-3123More trials in Durham
NJ
- Hackensack University Medical Center · Hackensack, NJ 07601Oncology Clinical Research Referral Office · Study contact · 551-996-1777 · OncologyResearchReferral@hmhn.orgMore trials in Hackensack
NY
- NYU Langone Health · New York, NY 10016 · Study contact · 212-263-4432More trials in New York
- Memorial Sloan Kettering Cancer Center · New York, NY 10065 · Study contact · 646-608-4042More trials in New York
PA
- Thomas Jefferson University, Sidney Kimmel Cancer Center · Philadelphia, PA 19107Aliya Rogers · Study contact · axr028@jefferson.eduMore trials in Philadelphia
- Fox Chase Cancer Center · Philadelphia, PA 19111 · Study contact · 215-214-1515More trials in Philadelphia
TN
- Sarah Cannon Research Institute (SCRI) Oncology Partners · Nashville, TN 37203 · Study contact · 615-329-7640More trials in Nashville
- Vanderbilt University Medical Center · Nashville, TN 37232 · Study contact · 615-936-8422More trials in Nashville
TX
- Mary Crowley Cancer Research · Dallas, TX 75230 · Study contact · 972-566-3000More trials in Dallas
- Baylor University Medical Center · Dallas, TX 75246 · Study contact · 888-507-3732More trials in Dallas
- MD Anderson Cancer Center · Houston, TX 77030 · Study contact · 888-989-5374More trials in Houston
WA
- Fred Hutchinson Cancer Center · Seattle, WA 98109 · Study contact · 855-557-0555More trials in Seattle