A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Phase 1
90
about 3.3 years
18+
21 sites in AZ, CA, FL +10
What this study is about
Researchers are testing a new treatment, CLSP-1025, for adults with solid tumors that have the p53 R175H mutation. The trial will determine the best dose of CLSP-1025 to use in people with this type of cancer.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take CLSP-1025
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
Primary: Part A: Determine the maximum tolerated dose (MTD) and/or the recommended dose(s) for expansion (RDE[s]), Part B: Evaluate the Objective response rate (ORR) of CLSP-1025 as a monotherapy in HLA-selected patients with advanced solid tumors that express the p53 R175H mutation
Secondary: Disease Control Rate, Duration of response (DOR), Half-life (t1/2) of CLSP-1025, Maximum plasma concentration (Cmax) of CLSP-1025, Number of patients with treatment-emergent adverse events, as assessed by CTCAE, v5.0, Number of patients with treatment-related adverse events, as assessed by CTCAE, v5.0, Overall Survival (OS), Part A: Objective Response Rate (ORR)
Oncology, Gastroenterology