MyCustom:Prospective Master Protocol Trial on Precision Medicine Treatment for Refractory Solid Tumors

Launched by TIANJIN MEDICAL UNIVERSITY SECOND HOSPITAL · Sep 2, 2023

Keywords

ClinConnect Summary

The MyCustom trial is a research study designed to explore a personalized medicine approach for patients with certain types of advanced solid tumors that have not responded to standard treatments. This study looks at how genetic information from a patient’s tumor can help guide treatment decisions. It aims to include adults aged 18 and older who have advanced or metastatic cancer, including types like small cell lung cancer, prostate cancer, and bladder cancer, among others. To participate, patients should have already tried all available standard treatments without success, or their cancer must be deemed unsuitable for standard therapies.

Participants in the trial can expect to undergo testing of their tumor’s genetic material to identify specific markers that might make them eligible for targeted therapies. The study is currently recruiting patients, and those interested will need to provide written consent to take part. It’s important to note that patients who are still suitable for standard therapies or have certain health conditions may not be eligible. This trial represents a hopeful step toward finding more effective treatment options for patients facing difficult-to-treat cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults(≥18 years of age)with pathologically confirmed advanced or metastatic solid cancer of any histological type, or an earlier diagnosis of cancer with a poor prognosis. Suffificient accessible tissue for molecular profifiling;
• • 2. Patients receiving their last line of standard treatment or who have received and failed all standard anticancer therapy (if available) or are unsuitable for further standard anticancer therapy. Cancers with a poor prognosis or low expected response rate to standard treatment (as judged by the investigator on the basis of available evidence) may be screened with respect to an earlier line of treatment;
• • 3. ECOG performance status of 0-4(Poor performance status caused by tumor diseases(3-4));
• • 4. Willing and potentially able to comply with study requirements,including treatment, timing and nature of required assessments;
• • 5. Signed, written informed consent to participate.
• Exclusion Criteria:
• • 1. Suitable for standard therapy;
• • 2. Specific contraindications to exposure to the investigationalproducts;
• • 3. Other comorbid conditions that may compromise assessing key outcomes or, in the judgement of the clinician, limit the ability of the patient to comply with the protocol;
• • 4. Symptoms and uncontrolled central nervous system (CNS) involvement in a patient with a non-central cancer;
• • 5. Pregnancy, lactation or inadequate contraception.