JAB-23E73 for Advanced Solid Tumors with KRAS Alteration
JAB-23E73
Colonic Diseases+12
+ Digestive System Diseases
+ Digestive System Neoplasms
Treatment Study
Summary
Study start date: May 29, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on testing a new drug, JAB-23E73, in adults who have advanced solid tumors that have a specific genetic change called KRAS alteration. The main aim is to find out if this drug is safe and how well it is tolerated by patients. The study also wants to understand how the body processes JAB-23E73 and to see if it has any initial effects on shrinking or controlling the tumors. This research is important because KRAS alterations are common in various cancers, and there are limited treatment options available for these patients. Participants in this study will receive JAB-23E73 to see how their bodies react to different doses. The study begins by gradually increasing the dose to find the highest amount that can be given safely. Once the safe dose is found, more patients with specific types of tumors, like colorectal cancer and pancreatic cancer, will receive this drug to further test its safety and effectiveness. Researchers will closely monitor participants for any side effects and measure how well the drug works in controlling the cancer. The findings could lead to new treatment options for patients with KRAS-related tumors.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.294 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
Inclusion Criteria: * Written informed consent. * Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF). * Histologically or cytologically confirmed locally advanced or metastatic solid tumors that are not suitable for curative interventions. * Patients must have KRAS alterations. * Participants are required to provide an archived tumor sample. * Patients with a life expectancy ≥3 months. * ECOG performance status score of 0 or 1. * Patients must have at least one measurable lesion as defined by RECIST v1.1. Exclusion Criteria: * Inability to swallow oral medications, or presence of gastrointestinal dysfunction or gastrointestinal disorders that may significantly alter the absorption of the study drug. * Patients who have previously been treated with KRAS G12C inhibitors, KRAS G12D inhibitors, or pan/multi-KRAS inhibitors. * Known serious allergy to JAB-23E73 or excipient. * Patients with primary central nervous system tumors. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures or medical intervention. * QT interval\>470 msec. * LVEF ≤50% assessed by ECHO or MUGA.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Secondary 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 4 locations
Washington University
St Louis, United StatesCleveland Clinic Foundation
Cleveland, United StatesHuntsman Cancer Institute
Salt Lake City, United States