YL242 Monotherapy and Combinations for Advanced Solid Tumors
YL242
+ YL242; Pembrolizumab
+ YL242; 5-FU; LV
Neoplasms
Treatment Study
Summary
Study start date: September 22, 2025
Actual date on which the first participant was enrolled.This clinical trial is designed to investigate a new treatment option for patients with advanced solid tumors, which are a type of cancer that has spread and is not easily treated. The study focuses on a new drug named YL242 and aims to understand how safe and tolerable it is when used alone or in combination with other treatments. Patients with these advanced tumors often have limited treatment options, so this study is important because it may lead to new ways to manage their condition effectively. Participants in this study will receive YL242, either on its own or alongside other therapies, and their health will be closely monitored. The treatment is administered in a controlled setting, and researchers will evaluate how the drug behaves in the body and its effects on the tumors. The main focus is to see if the treatment is safe and how well it is tolerated by patients. Through regular health assessments, the study aims to gather comprehensive information on the potential benefits and any possible side effects of YL242, contributing to the development of better cancer treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.424 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: * Aged ≥18 years. * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 * Adequate organ and bone marrow function * Tumor type: Part 1-3: Advanced/unresectable or metastatic solid malignant tumor; Have received at least one prior line of systemic anti-tumor therapy Part 4: locally advanced or metastatic non-sq NSCLC without AGA and HCC; Have not received any systemic anti-tumor therapy; Part 5: mCRC, have received at least one (5a) or one (5b) prior line of systemic anti-tumor therapy Part 6: advanced or metastatic HER2-negative G/GEJ; have received at least one (6a) or one (6b) prior line of systemic anti-tumor therapy Exclusion Criteria: * Be intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor * Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases * Clinically significant concomitant pulmonary disease * A history of leptomeningeal carcinomatosis or carcinomatous meningitis * Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
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 15 locations
US-206
Grand Rapids, United StatesUS-205
Nashville, United StatesAUS-102
Darlinghurst, Australia