Posted: 30 September 2025
Chimeric Therapeutics announced further evidence of disease control and tumour shrinkage in its CHM CDH17 Phase 1/2 clinical trial, following confirmation by the Safety Monitoring Committee that Dose Level 2 is safe for additional exploration.
Professor Jennifer Eads, Lead Investigator at the University of Pennsylvania, said: “After almost a decade of preclinical and clinical work, I am thrilled to see CHM CDH17 demonstrating real anti-tumour activity and durability that can really be meaningful for patients.”
Four subjects have been treated at Dose Level 2, with two undergoing tumour assessments. Both showed “mixed responses,” with total disease burden reduced by 12 per cent in colorectal cancer and between 6–16 per cent in neuroendocrine tumours, resulting in RECIST assessments of Stable Disease. Of all tumours imaged, one decreased in size by 37 per cent. Chimeric confirmed there was no evidence of off-target effects or gastrointestinal toxicity.
RECIST 1.1 is measured by changes in tumour size seen on scans. A Complete Response (CR) means all visible tumours have disappeared. A Partial Response (PR) means the total tumour size has shrunk by at least 30 per cent. Stable Disease (SD) means the cancer has shrunk up to 30 per cent. Progressive Disease (PD) indicates tumour growth of 20 per cent or more, or the appearance of new tumours.
In addition, a colorectal cancer patient treated at Dose Level 1 continued to demonstrate Stable Disease more than 10 months after receiving a single dose, with one tumour shrinking by 18 per cent and the response deepening over time.
Chief Executive Officer Dr Rebecca McQualter said: “We’re very encouraged to see these positive early results of disease control, and we look forward to receiving results from the additional patients in the near term as we continue to progress CHM CDH17.”
The Phase 1/2 study (NCT06055439) is designed to identify a recommended Phase 2 dose and evaluate safety and response in patients with advanced colorectal, gastric and gastrointestinal neuroendocrine tumours. CHM CDH17 is a third-generation CAR-T cell therapy targeting CDH17, a biomarker associated with poor prognosis and metastases in gastrointestinal cancers.
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