* Ph1/2 Study of LOXO-292 in Paeds Patients with RET-Altered CNS Tumours
Research type
Research Study
Full title
A Phase 1/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors
IRAS ID
306043
Contact name
Sara Stoneham
Contact email
Sponsor organisation
Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company
Eudract number
2019-000212-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 22 days
Research summary
Receptor tyrosine kinases (RTKs) are a subclass of tyrosine kinases (enzymes) that are involved in mediating cell-to-cell communication and controlling a wide range of complex biological functions, including cell growth, motility (movement), differentiation, and metabolism. The RET RTK was discovered in 1985 and alterations in the gene that codes for it has been shown to cause several human cancers affecting both adult and paediatric patient populations, such as a range of thyroid cancers, infantile myofibromatosis, infantile fibrosarcoma and chronic myeloproliferative neoplasms.
Treatment options for patients with these conditions are limited, with the most common interventions being surgery or intensive chemotherapy which can result in severe side effects and long-term consequences. Multikinase inhibitors are available that target the RET RTK (amongst others), but effects are limited due to incomplete inhibition of RET in addition to significant toxicity from inhibition of other targets. The treatment being tested in this study, selpercatinib, is a highly selective small molecule that potently inhibits the RET RTK with limited effects on other targets.
LOXO-18036 (J2G-OX-JZJJ) is a Phase 1/2, open-label, multicentre study of selpercatinib in paediatric participants with advanced RET-altered solid or primary central nervous system tumours. The primary objective of the Phase 1 part is to determine the safety, including dose-limiting toxicities (DLTs), of selpercatinib. The primary objective of the Phase 2 part is to determine the objective response rate (ORR) as measured by proportion of participants with best overall confirmed complete response (CR) or partial response (PR) following selpercatinib treatment. Participants will receive oral selpercatinib continuously until progressive disease, unacceptable toxicity, or any other reason for treatment discontinuation.
Up to 78 participants will be enrolled into the study. Recruitment in the UK will take place in hospitals. The study is sponsored by Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0156
Date of REC Opinion
11 Mar 2022
REC opinion
Further Information Favourable Opinion