Treatment for adult patients with solid tumors that have a specific p53 mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, open-label, multicenter study evaluates the safety and effectiveness of CLSP-1025, a T cell engager targeting solid tumors with the p53 R175H mutation. The study consists of two parts: a dose escalation phase to determine the recommended doses for further testing and an expansion phase to assess the preliminary antitumor activity and safety of the treatment. Participants must be HLA-A*02:01 positive and have advanced solid tumors that have not responded to standard therapies.

Why it matters

Who can join: the full rules

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

Where it's running

• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• The University of Arizona Cancer Center
  Tucson, Arizona, United States Recruiting
• USC - Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• University of California Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• University of Miami - Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Lauren Harshman, MD
• Email: LHarshman@clasptx.com
• Phone: +1-617-812-1431

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.