This is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible and safe to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments can help control the growth of the patient tumors or stop them from getting worse.
Patients with advanced thyroid cancer often have very few treatment options, and standard therapies usually cannot cure the disease. Some types grow and spread quickly and do not respond to surgery and radioactive iodine. For patients with other types, existing drugs may slow the disease but can cause strong side effects, limiting their usefulness. This study is testing a new personalized approach called network pharmacology-based drug repurposing. This concept uses genetic tumor information to identify combinations of existing approved drugs that may work better together. The idea is that targeting several connected networks in the tumor at the same time may be more effective than standard treatments that focus on a single target. The main objective is to study if it is feasible and safe to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments can help control the growth of the patient tumors or stop them from getting worse. This is an exploratory, single-arm phase Ib umbrella trial. Each patient receives a personalized treatment based on the genetic profile of their tumor. The study focuses on understanding feasibility and safety. Each participant will be in the study for approximately 4 months. The first month is used to examine the tumor of the patient and select the best personalized treatment. Once the treatment is chosen and both the patient and their doctor agree, the patient will receive the treatment for three months. During treatment, patients will have regular check-ups, blood tests, scans, and questionnaires to monitor safety and see how well the treatment is controlling the tumor. This study is funded by the EU horizon project Precision drug REPurpOsing For EUrope and the world (REPO4EU) under grant agreement No. 101057619
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The therapy will consist of (one or more) approved drugs.
Feasibility
Number and proportion of enrolled patients who initiate study treatment.
Time frame: 12 weeks
Safety
Number and proportion of patients who experience treatment-related adverse events (CTCAE v5.0).
Time frame: 12 weeks
Preliminary efficacy
Disease control rate (DCR) at 3 months, defined as the number and proportion of patients achieving stable disease (SD), partial response (PR), or complete response (CR), according to RECIST 1.1.
Time frame: 12 weeks
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