A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
NCT06778863 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-02-13
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.
Conditions
- Advanced Solid Tumor
- Unresectable Solid Tumor
- Metastatic Solid Tumor
- Colorectal Adenocarcinoma
- Pancreatic Adenocarcinoma
- Lung Cancer
- Ovarian Cancer
- Breast Cancer
- Head and Neck Squamous Cell Carcinoma
- Prostate Cancer
- Bladder Cancer
Interventions
- DRUG
-
CLSP-1025
CLSP-1025 will be administered by IV infusion
Sponsors & Collaborators
-
Clasp Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-28
- Primary Completion
- 2027-12-31
- Completion
- 2028-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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