GUARDIAN-101: A Phase 1 Dose Escalation and Expansion Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Clasp Therapeutics, Inc.
Summary
Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.
Description
This Phase 1, open-label, multicenter study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of CLSP-1025 when administered to HLA-A\*02:01-positive adult patients with advanced solid tumors that harbor the p53 R175H mutation. The study will be conducted in 2 parts: Part A Monotherapy Dose Escalation to determine the recommended dose(s) for expansion (RDE\[s\]) and Part B Monotherapy Expansion to explore the preliminary antitumor activity as well as further characterize the safety, tolerability, PK, and PD of CLSP…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCLSP-1025
CLSP-1025 will be administered by IV infusion
Locations (21)
- HonorHealth Research InstituteScottsdale, Arizona
- The University of Arizona Cancer CenterTucson, Arizona
- USC - Norris Comprehensive Cancer CenterLos Angeles, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- University of California San FranciscoSan Francisco, California
- University of Miami - Sylvester Comprehensive Cancer CenterMiami, Florida