A Phase 1/2 Study of LOXO-292 in Patients with Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1/2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET-Fusion _Positive Solid Tumours, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001)
IRAS ID
246991
Contact name
Anna Minchom
Contact email
Sponsor organisation
Loxo Oncology, Inc.
Eudract number
2017-000800-59
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 27 days
Research summary
This is a multi-center Phase 1/2 study in patients with advanced solid tumours, including RET-fusion NSCLC, MTC and other tumours with increased RET activity. In this study the participant and the investigator know which treatment is being administrated. LOXO-292 is designed to inhibit a protein called RET as deeply as possible, and avoid other pathways in the cancer cell. As a result, LOXO-292 might be expected to be more effective in tumours with abnormalities in the RET gene. Non-small cell lung and thyroid cancer are most commonly associated with RET gene abnormalities, though other tumour types may have them too. The participant's doctor can help you learn whether your tumour has a RET gene abnormality.
This study is comprised of two parts: dose escalation and dose expansion. Patients with RET alterations in tumour and/or blood will be identified through molecular assays, as performed for clinical evaluation.
Both dose escalation and dose expansion will consist of a screening period, a treatment period, an End of Treatment (EOT) visit, a Safety Follow-up visit and Long-Term Follow-up.Ongoing safety, disease status, survival and subsequent anticancer therapy(ies) will be assessed during long-term follow-up.
LOXO-292 will be administered in oral capsule form, once daily (QD) or twice daily (BID), depending upon cohort assignment. Dosing will be fixed as total milligram (mg; as opposed to weight-based or body surface area-based).
Approximately 100 sites will participate in the study in United States, Europe and Asia and Australia.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/0044
Date of REC Opinion
22 Feb 2019
REC opinion
Further Information Favourable Opinion