Advanced Solid Tumor study: CLSP-1025
Official title A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
ClinicalTrials.gov ID: NCT06778863
What this study is testing
What is CLSP-1025?
an investigational IV infusion medicine being studied as a potential treatment for advanced solid tumors with the p53 R175H mutation. is designed to engage a patient's T cells with tumor cells that display the p53 R175H mutation in the context of HLA‑A*02:01.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find the safest dose of the drug and see if it helps shrink tumors in people with specific cancers.
- Who it's for
- Adults with advanced solid tumors, such as lung, breast, or colorectal cancer, that have a specific p53 gene mutation.
- What's involved
- Participants will receive the drug CLSP-1025, which is designed to help the immune system target cancer cells, along with regular medical checks and tests.
- Time commitment
- The study involves ongoing visits for treatment and monitoring, but the total duration is not specified in the provided text.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Known active central nervous system metastases and/or carcinomatous meningitis
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Tucson, Arizona, United States; Los Angeles, California, United States; Sacramento, California, United States; San Francisco, California, United States; Miami, Florida, United States and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.