Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
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
- * 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
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No