Clinical Trial

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

Study acronym: GUARDIAN-101
Recruiting Phase 1
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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.
Protocol Amendment History 24 amendments
This ClinicalTrials.gov record has been amended 24 times since 2025-01-12; most recent amendment 2026-02-12.
Status change: Not Yet Recruiting → Recruiting 2025-02-28
Trial Details
NCT Number NCT06778863
Lead Sponsor Clasp Therapeutics, Inc.
Conditions Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor, Colorectal Adenocarcinoma, Pancreatic Adenocarcinoma, Lung Cancer, Ovarian Cancer, Breast Cancer +3 more
Enrollment 90 participants
Start Date 2025-02-28
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-02-13