A Phase 2 Multi-Arm Study of Magrolimab in Patients with Solid Tumors
Research type
Research Study
Full title
A Phase 2 Multi-Arm Study of Magrolimab in Patients with Solid Tumors
IRAS ID
303731
Contact name
Farah Louise Lim
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2020-005265-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 8 days
Research summary
Research Summary:
For many patients with solid tumours, immune checkpoint inhibitors have significantly improved treatment outcomes. Standard of care for most tumour types now includes a combination of chemotherapy, immune checkpoint inhibitors, or both. However, if this fails the remaining options are limited. Single-agent chemotherapy is standard in this situation; however, the efficacy is limited. This means novel agents that can safely combine and enhance the efficacy of chemotherapies are needed to improve treatment outcomes.Magrolimab is not currently approved and is being studied in multiple types of cancers. It acts to help prevent cancer cells evading the immune system’s response and leads to the elimination of cancer cells from solid tumours. Magrolimab’s efficacy is best enhanced in combination with other anti-cancer agents.
This trial will aim to evaluate Magrolimab combination with chemotherapy in multiple solid tumours, including locally advanced/metastatic non-small cell lung cancer, locally advanced/metastatic urothelial cancer, and locally advanced/metastatic small cell lung cancer.
This study is split into two parts; the initial phase (safety run-in) is to confirm a safe dose of Magrolimab in combination with docetaxel, and the second part (phase 2) is to see if Magrolimab in combination with docetaxel is effective in treating various types of solid tumours. In Phase 2 participants will be allocated into 1 of 3 cohorts depending on their type of cancer.
Participants will be allocated into either the safety run-in or Phase 2 and treatment will be given in 21-day cycles. During the study participants will undergo multiple types of assessments, e.g. blood tests, CT/MRI scans, tumour biopsies, etc.
Other purposes of this study include determining the quantity of Magrolimab in the blood and the side effects these drugs have on the body.
The study will involve around 128 patients between 50 locations worldwide.
Summary of Results:
PLS:https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gileadclinicaltrials.com%2F-%2Fmedia%2Fproject%2Fgileadclinicaltrial%2Fstudy-documents%2Fgs-us-548-5918%2Fgs-us-548-5918_plain-language-summary-english.pdf&data=05%7C02%7Cwales.rec5%40wales.nhs.uk%7C1eed1cff290744affd5e08dda731408f%7Cbb5628b8e3284082a856433c9edc8fae%7C0%7C0%7C638850552335139988%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=BiV77bQwbgllHzxaq5xND991degEndGE0xChJKKm%2FE4%3D&reserved=0REC name
Wales REC 5
REC reference
22/WA/0078
Date of REC Opinion
25 May 2022
REC opinion
Further Information Favourable Opinion