Phase I/Ib clinical trial of PM54 in Advanced Solid Tumors patients
Research type
Research Study
Full title
Phase I/Ib, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM54 Administered Intravenously to Patients with Selected Advanced Solid Tumors
IRAS ID
1007238
Contact name
Luis Mora Capitán
Contact email
Sponsor organisation
Pharma Mar, S.A.
Eudract number
2022-002031-65
Research summary
PM54 is an experimental anticancer drug that has been shown to kill cancer cells in several animal studies. Since this study is the first time PM54 is being tested in humans, it will evaluate whether the positive effect observed on cancer cells in animals is also present in humans.
This study will be divided into two stages. The main purpose of the first stage of this study is to test the safety of PM54, an experimental new drug, at different dose levels. The researchers would like also to find out the effects, good or bad, that PM54 has on the population under study. Small groups of people are receiving a due dose of PM54 that, if well tolerated (have few or easily manageable side effects), is increased in the next small group. This will continue until the highest safe dose of the study drug that can be given without causing serious or unmanageable side effects is found. Some patients may experience important or serious side effects, and these are more likely to occur as the dose of PM54 is increased. The dose of PM54 will stop being increased when certain side effects are seen. Once the highest safe dose of PM54 has been found, the second stage of this study will begin and a larger group of patients will be enrolled into at least five tumour specific cohorts with the main purpose of learning more about the effects of PM54 on some specific types of cancer. The secondary purpose of this study is to determine how the experimental study drug PM54 is distributed throughout and eliminated from the body, and to determine if more information about how it works against cancer and interacts with the body can be obtained.
A complete cycle of treatment will last 21 days and PM54 will be evaluated as an intravenous infusion administered on Day 1 of each 21-day cycle.PM54 will be evaluated as an intravenous infusion administered on Day 1 of each 21-day cycle.
REC name
West of Scotland REC 1
REC reference
23/WS/0039
Date of REC Opinion
19 Apr 2023
REC opinion
Further Information Unfavourable Opinion