NCT06778863

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Clasp Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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-1025 at the RDE(s).

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

Type	Name	Description
DRUG	CLSP-1025	CLSP-1025 will be administered by IV infusion

Timeline

• Start date: 2025-02-28
• Primary completion: 2027-12-01
• Completion: 2028-06-01
• First posted: 2025-01-16
• Last updated: 2026-02-13

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study