NEW YORK – Clasp Therapeutics on Monday said that the first advanced solid tumor patient has received its investigational tumor-specific T-cell engager CLSP-1025 within a Phase I trial.
CLSP-1025 is designed to target cancer cells expressing the p53 R175H mutation, which shows up in various solid tumors, including colorectal, pancreatic, lung, gastric, esophageal, gynecological, and prostate cancers. "Truncal mutations like p53 R175H occur early in tumorigenesis and are present in every tumor cell, making them ideal targets for immune system attack," Clasp Therapeutics, which has dual headquarters in Cambridge, Massachusetts, and Rockville, Maryland, said in a statement.
The agent is a next-generation T-cell engager that homes in on tumor-specific peptides emerging from mutations driving a patient's cancer, according to Clasp Therapeutics, a feature it expects will reduce the risk of toxicities compared to first-generation treatments that target proteins on tumor and normal cells.
"Advancing CLSP-1025 into the clinic is an important step in validating the potential of our pHLAre platform to overcome the limitations of current T-cell engagers and offer a breakthrough treatment option for patients," Lauren Harshman, senior VP of clinical development at Clasp Therapeutics, said in a statement.
At the American Association for Cancer Research's annual meeting ongoing currently in Chicago, the company presented preclinical data on CLSP-1025's selectivity, activity, pharmacokinetics, and safety.
Based on this preclinical data, the company is now moving the treatment into the Phase I GUARDIAN-101 trial, a dose-escalation study that will explore CLSP-1025's safety and demonstrate its initial anti-tumor activity. Patients enrolled in the study must be HLA-A*02:01 positive and have an advanced solid tumor that harbors the p53 R175H mutation. The aim within this Phase I study is to identify the dose of CLSP-1025 that researchers will test in later-stage trials.