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

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).

Includes various types of solid tumors, including colorectal cancer, pancreatic cancer, lung cancer, ovarian cancer, breast cancer, head and neck squamous cell carcinoma, squamous cell carcinoma, prostate cancer, bladder cancer, other neoplasms, and head and neck cancer.

Sponsor

CLASP Therapeutics, Inc.

Status of enrollment

Accepting new patients

Ages Eligible for Study

Adults aged 18 and older

Genders Eligible for Study

Female and Male

Disease indication

Solid Tumors that Harbor the p53 R175H Mutation

Principal Investigator

David Oh, MD, PhD

Contact

[email protected] 

 

Additional study eligibility details can be found at UCSF Clinical Trials.