NRM-823 for Advanced or Metastatic Refractory Solid Tumors
NRM-823
Squamous Cell Carcinoma of Head and Neck+28
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: October 30, 2025
Actual date on which the first participant was enrolled.This clinical trial focuses on testing a new drug called NRM-823, designed for people with advanced or hard-to-treat solid tumors. The trial aims to determine how safe this drug is when used alone and in combination with another type of cancer treatment known as immune checkpoint inhibitors. These inhibitors help the immune system recognize and attack cancer cells more effectively. This study is important because it explores new treatment options for patients whose tumors have not responded well to existing therapies, potentially offering new hope for managing their condition. Participants in this study will receive NRM-823 either by itself or alongside an immune checkpoint inhibitor. The study is divided into three parts. Initially, the research focuses on finding the safest dose of NRM-823 alone. After identifying this dose, the research will test its effects further in a larger group. In the final part, the study will examine how well the drug works when combined with the checkpoint inhibitor. The main focus is to observe any side effects participants might experience and to evaluate how the combination impacts the tumors. The results will help determine the best way to use these treatments together in the future.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Normunity Investigational Site
Denver, United StatesOpen Normunity Investigational Site in Google MapsNormunity Investigational Site
New Haven, United StatesNormunity Investigational Site
Minneapolis, United StatesNormunity Investigational Site
Maumee, United States