Table of contents
- Clinical trial overview
- Who the trial is for
- Trial phase and study design
- What the study measures
- Trial status and enrollment
- Important terms explained
Clinical trial overview
The available study is an interventional trial of Imgn151 in women with recurrent gynecological cancers.[1] It is described as the first trial in humans and is designed to evaluate safety and early signs of efficacy, which means whether the treatment may help as well as whether it can be given safely.[1]
The cancers being studied are recurrent endometrial cancer, recurrent epithelial ovarian cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cancer, and recurrent cervical cancer.[1]
Who the trial is for
This study is for women whose gynecological cancer has come back after treatment.[1] In trial language, recurrent means the cancer returned after a period of improvement or no visible disease.[1]
The trial includes several cancer types in the same general group of diseases, which helps researchers learn whether the study treatment can be tested across different recurrent gynecological cancers.[1]
Trial phase and study design
The study is a Phase 1/2 trial.[1] Phase 1 studies mainly look at safety and the right dose, while Phase 2 studies also look more closely at whether the treatment may be effective.[1]
The trial is interventional, which means the researchers give the study treatment and then observe what happens.[1] Imgn151 is given intravenously, meaning through a vein into the bloodstream.[1]
The trial is also described as the first trial in humans, so it is an early step in clinical research for this treatment.[1]
What the study measures
The main outcomes are focused on safety and dose finding.[1] Researchers will measure adverse events, which are unwanted medical problems that happen during the study, whether or not the treatment caused them.[1]
The study will also measure serious adverse events, which are more severe problems that may be life-threatening or need hospital care.[1] Another key measure is dose-limiting toxicities, meaning side effects strong enough to limit how much treatment can be given.[1]
The trial aims to determine the recommended dose of Imgn151 monotherapy, which means the best dose for using Imgn151 alone rather than with another treatment.[1]
The brief summary also says the researchers want to assess safety and tolerability, and to identify the maximum tolerated dose or maximum administered dose if no maximum tolerated dose is found.[1] Tolerability means how manageable the treatment is for patients.[1]
Trial status and enrollment
The trial status is Authorised.[1] The planned enrollment is 403 participants, which is the number of people researchers expect to include in the study.[1]
This enrollment size suggests the study is designed to gather enough information to judge safety and help choose the dose for later research.[1]
Important terms explained
Monotherapy means the study treatment is used by itself, not combined with other anti-cancer drugs.[1]
Maximum tolerated dose is the highest dose patients can receive without too many serious side effects.[1]
Maximum administered dose is used if no maximum tolerated dose can be defined, and it means the highest dose actually given in the study.[1]
Primary endpoint is the main result the researchers want to measure, such as safety or dose selection.[1]
