MS201924_0001 Open-label, Multicenter Trial of M1774
Research type
Research Study
Full title
An Open-label, Multicenter Trial of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M1774 in Participants with Metastatic or Locally Advanced Unresectable Solid Tumors
IRAS ID
271981
Contact name
Johann de Bono
Contact email
Sponsor organisation
Merck Healthcare KGaA
Eudract number
2019-002203-18
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 1 months, 14 days
Research summary
This is an Open-label (participants and the medical team will know what treatments are being given), Phase I, first-in-human, multicentre, 3-part clinical trial. The purpose of this study is to see how efficient the drug M1774 is as a treatment of patients with metastatic or locally advanced solid tumours.
The study is divided into 3 main parts, Parts A1, A2, and A3:
• Part A1 – the purpose of this part of the study is to test and find the safest dose of the study drug to use in Part A2 and Part A3.
• Part A2 – the purpose of this part of the study is to see how food affects the way the study drug acts in the body.
• Part A3 – the purpose of this part of the study is to further test how safe the study drug is and whether it works in tumours with certain changes in a gene.
Participants are initially invited to participate in Part A1 of the study only. The protocol includes all three parts, hence Part A2 and Part A3 are included in this application. When Part A2 and Part A3 open up, these parts of the study will be submitted as substantial amendments with updated Patient Information Sheets and Informed Consent Forms.During the Part A1, the study will also evaluate pharmacokinetics (PK), pharmacodynamics (PD) and biomarkers how the body is affected by and responds to the study drug.
The study also has optional genetic research and optional tumour biopsies collection.
Approximately 18 to 24 people will participate in Part A1 of this study. The study will be conducted in up to 5 medical centres in the United States and the United Kingdom.
Participation in this research study will last until the disease gets worse or the study doctor decides to stop the treatment if considered unsafe to continue to participate in the study. However, due the severity of the disease we anticipate that in average participants will be treated for 4 cycles (1 cycle = 21 days).
Key Inclusion and Exclusion criteria:
Inclusion:
• Male and females aged 18 – 64 years of age.
• Locally advanced or metastatic disease that is refractory to standard therapy or for participants who have exhausted all standard of care options which may convey clinical benefit.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.Exclusion:
• Continuance of toxicities due to prior anticancer therapies (e.g., radiotherapy, chemotherapy, immunotherapies, etc.) that do not recover to ≤ Grade 1.
• Unstable angina, myocardial infarction, congestive heart failure ≥ II) or a coronary revascularisation procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 450 msec for males and > 470 msec for females.
• Active fungal, bacterial and/or viral infection. Individuals with known human immunodeficiency virus and/or viral hepatitis (B and/or C). However, individual with hepatitis C treated with curative therapy are not considered actively infected.Enrolment timelines:
Planned start date in UK; March 2020
Last participants in UK; September 2021REC name
London - Surrey Borders Research Ethics Committee
REC reference
19/LO/1837
Date of REC Opinion
13 Jan 2020
REC opinion
Further Information Favourable Opinion