Ph1,dose-escalation & cohort expansion REGN3767 in adv. malignancies
Research type
Research Study
Full title
A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (anti-LAG-3 mAb) Administered Alone or in Combination with REGN2810 (anti-PD-1 mAb) in Patients with Advanced Malignancies
IRAS ID
228323
Contact name
Mark Middleton
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 15 days
Research summary
Research Summary -
The purpose of this study is to assess the safety, tolerability and initial anti-tumour activity of the study drugs, REGN 3767, alone (monotherapy) and in combination with REGN2810 (anti-PD-1), in patients with advanced cancer.\n\nLymphocyte activation gene 3 (LAG-3) and Programmed death 1 (PD-1) receptor are cellular checkpoints which inhibit some immune cells, therefore preventing them destroying cancer cells. REGN3767 is a drug that blocks LAG-3 and REGN2810 blocks PD-1. Blocking LAG-3 and/or PD-1 may help immune cells destroy cancer cells.\n\nThis study has 2 parts. The goal of Part 1, dose escalation phase, was to determine what is the highest, most safe dose of REGN3767 alone or in combination with REGN2810. Patients in the UK will only be enrolled in Part 2, dose expansion phase. The goal of Part 2 is to use the drug doses found in Part 1 to investigate how well REGN3767 works to shrink specific tumour types, either alone or in combination with REGN2810. \n\nAfter a screening period of up to 28 days, patients will receive up to seventeen 21-day treatment cycles, for a total of up to 51 weeks, followed by a 24-week follow-up period. Each patient will receive REGN3767 alone, or with REGN2810 every 21 days (Q3W), each study drug is given as a 30-minute infusion. Response assessments will be made every 6 weeks for the first 24 weeks and then every 9 weeks for the subsequent 27 weeks. Safety assessments will be conducted at each study drug dosing visit and at additional visits for the first 28 days of therapy. \n\nIn this study, there will be 235 patients recruited in the expansion phase of this trial. The study will take place in Europe, South Korea and the USA. The study will last approximately 2 years.
Summary of Results -
When available, a plain language summary of results will be posted on https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Furl.uk.m.mimecastprotect.com%252Fs%252FAvKuC1r1LSB0gQG3ILfNUVzArq%253Fdomain%253Dtrialsummaries.com%2FNBTI%2FuV28AQ%2FAQ%2F3656b4f4-6592-4c1f-a42c-f6766c27ec00%2F1%2FB0DFhH5Hri&data=05%7C02%7Coxforda.rec%40hra.nhs.uk%7Cc9534b639e5b446fe2eb08dd705ea5d1%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638790273992110127%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=R%2F7bN%2BdeijOV9yFFp1jOkyQV793ehZ48IhZK73ajFK4%3D&reserved=0
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0325
Date of REC Opinion
30 Aug 2017
REC opinion
Further Information Favourable Opinion