Recruiting PHASE1 INTERVENTIONAL 2-arm NCT06778863

A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation (GUARDIAN-101)

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

Sponsor: Clasp Therapeutics, Inc.

Conditions Advanced Solid Tumor Bladder Cancer Breast Cancer Colorectal Adenocarcinoma Head and Neck Squamous Cell Carcinoma Lung Cancer Metastatic Solid Tumor Ovarian Cancer Pancreatic Adenocarcinoma Prostate Cancer Unresectable Solid Tumor

Interventions CLSP-1025

Updated 10 times since 2025 Last updated: Feb 12, 2026 Started: Feb 28, 2025 Primary completion: Dec 31, 2027 Completion: Jun 30, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Advanced Solid Tumor and Bladder Cancer and is currently actively recruiting participants. Clasp Therapeutics, Inc. leads this study, which shows 10 recorded versions since 2025 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

10 versions recorded

Feb 2026 — Present [monthly]

Recruiting PHASE1
Jan 2026 — Feb 2026 [monthly]

Recruiting PHASE1
Dec 2025 — Jan 2026 [monthly]

Recruiting PHASE1
Nov 2025 — Dec 2025 [monthly]

Recruiting PHASE1
Oct 2025 — Nov 2025 [monthly]

Recruiting PHASE1

▶ Show 5 earlier versions

Aug 2025 — Oct 2025 [monthly]

Recruiting PHASE1
Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE1
May 2025 — Jul 2025 [monthly]

Recruiting PHASE1
Apr 2025 — May 2025 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Feb 2025 — Apr 2025 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Clasp Therapeutics, Inc.

Data source: Clasp Therapeutics, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Baltimore, United States , Chicago, United States , Dallas, United States , Durham, United States , Hackensack, United States , Houston, United States , Lexington, United States , Los Angeles, United States , Miami, United States , Nashville, United States and 7 more locations