A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation

Launched by CLASP THERAPEUTICS, INC. · Jan 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CLSP-1025 for adults with certain types of solid tumors that have a specific genetic mutation known as p53 R175H. These tumors can include advanced cancers such as colorectal, pancreatic, lung, ovarian, breast, head and neck, prostate, and bladder cancers. The trial is currently recruiting participants who are at least 18 years old and have tumors that have not responded to standard treatments or for which no standard treatments are available. To be eligible, patients must also have a specific genetic type (HLA-A*02:01) and be in good enough health to participate.

Participants in this study will receive CLSP-1025, which is designed to help the immune system target and attack their cancer cells more effectively. The trial is in its early phases, so researchers are focused on finding the right dosage and monitoring how well the treatment works. It's important to note that certain health conditions, prior treatments, or infections may prevent someone from joining the study, so potential participants should discuss their situation with their doctor to see if they qualify.

Gender

ALL

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