Ph1 Study of LOXO-783 in Solid Tumours with a PIK3CA H1047R Mutation
Research type
Research Study
Full title
A Study of LOXO-783 Administered as Monotherapy and in Combination with Anticancer Therapies for Patients with Advanced Breast Cancer and Other Solid Tumors with a PIK3CA H1047R Mutation
IRAS ID
1005403
Contact name
Sam Morris
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2022-000175-40
Clinicaltrials.gov Identifier
Research summary
This research study is being done to test the safety of an investigational treatment called LOXO-783. LOXO-783 is an investigational (or experimental) drug, taken orally, that may treat certain cancers. It was designed to target a particular abnormality (called a PIK3CA mutation) that can occur in some types of cancer cells and may be linked to the development of the disease. This abnormality is tested in advance and if a potential participant's cancer has the abnormality, they may be considered for enrolment in this study. LOXO-783 is expected to be more effective at treating cancers with this abnormality.
LOXO-PIK-21001 is a Phase 1a/1b, open-label, multicentre study of LOXO-783 on its own (monotherapy) and in combination with other therapies in participants with solid tumours that have a specific PIK3CA mutation. The primary objective of the phase 1a part is to determine the recommended phase 2 dose (RP2D) of LOXO-783 as a monotherapy. The primary objective of the phase 1b part is to determine the RP2D of LOXO-783 in combination with other therapies, which will be achieved by enrolling participants into a range of cohorts testing various combinations. Participants will receive oral LOXO-783 monotherapy or in combination with other anti-cancer therapies continuously until progressive disease, unacceptable toxicity, or any other reason for treatment discontinuation.
Up to 260 participants will be enrolled into the study worldwide. Recruitment in the UK will take place in hospitals. The study is sponsored by Loxo Oncology, Inc. on Behalf of Eli Lilly and Company.
REC name
Wales REC 1
REC reference
22/WA/0210
Date of REC Opinion
15 Sep 2022
REC opinion
Further Information Favourable Opinion