Safety and Tolerability Evaluation of JAB-30355 in Advanced Solid Tumors with TP53 Y220C Mutation
JAB-30355
Urogenital Diseases+12
+ Genital Diseases
+ Adnexal Diseases
Treatment Study
Summary
Study start date: July 24, 2024
Actual date on which the first participant was enrolled.This clinical trial aims to test a new treatment called JAB-30355 for adults who have advanced solid tumors with a specific genetic change known as the TP53 Y220C mutation. This mutation can make cancer more difficult to treat, so finding effective treatments is important. The study's goal is to see if JAB-30355 is safe and can help fight these types of tumors. It is hoped that this research will lead to better treatment options for patients with these challenging cancers. The study is divided into two parts. In the first part, called the Dose Escalation Phase, participants receive increasing doses of JAB-30355 to find the highest dose that can be safely given. This part helps to assess the safety and how well participants tolerate the treatment. In the second part, the Dose Expansion Phase, more participants will receive JAB-30355 at the doses deemed safe to further investigate its effects and benefits. Results are measured by observing the treatment's impact on the tumors and any side effects experienced by the participants.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.144 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). * ECOG performance status score of 0 or 1. * Has been treated with at least one line of systemic therapy for that tumor type and stage. * Have documentation of confirmed TP53 Y220C mutation. * At least 1 measurable lesion per RECIST v1.1. * Adequate hematological, renal and hepatic function and appropriate coagulation condition. * Able to swallow and retain orally administered medication. Exclusion Criteria: * Active brain or spinal metastases or primary CNS tumor. * Active infection requiring systemic treatment within 7 days. * Active HBV or HCV. * Any severe and/or uncontrolled medical conditions. * LVEF ≤50% assessed by ECHO or MUGA. * QTcF\>470 msec.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
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 13 locations
Research site
Lake Mary, United StatesResearch site
St Louis, United StatesResearch site
Cleveland, United States