Studio di fase 1b/2 sulla sicurezza e l'efficacia di ifinatamab deruxtecan in bambini e adolescenti con tumori solidi recidivanti o refrattari

Baseline Assessment

After joining the study, you will undergo a baseline visit that includes a medical history review, a physical Examination, blood tests, and imaging studies to document the current state of the tumor.

The purpose of these assessments is to establish reference values that will be used to compare later results.

First infusion of <b>ifinatamab deruxtecan</b>

You will receive ifinatamab deruxtecan as an intravenous infusion of a solution prepared for infusion.

The exact dose (referred to as the recommended dose for expansion, rde) will be determined by the study protocol based on safety data.

The infusion is administered by qualified staff in a clinical setting and may be repeated according to the study Schedule (for example, every three weeks), although the precise interval is defined by the protocol.

Post‑infusion observation

Immediately after the infusion you will be observed for a short period to monitor vital signs and to detect any immediate reactions.

Blood samples may be taken to assess drug levels and early safety markers.

Regular safety monitoring

Before each subsequent infusion you will undergo safety checks that include blood tests, physical Examination, and review of any symptoms you have experienced.

If a dose‑limiting toxicity (a side effect severe enough to limit further dosing) or other adverse events occur, the study team may adjust the dose or pause treatment.

Tumor response Evaluation

At predefined intervals (for example, every eight weeks) imaging studies will be performed to evaluate the tumor’s response.

The results are used to calculate the objective response rate and other efficacy measures such as disease control at four months.

Dose adjustment or discontinuation

If you experience a dose‑limiting toxicity or other serious adverse events, the protocol may require a dose reduction, a temporary hold, or permanent discontinuation of the study drug.

The decision is based on predefined Criteria that prioritize your safety.

End‑of‑treatment follow‑up

After the last infusion or if treatment is stopped early, you will continue to have follow‑up visits to monitor long‑term safety and disease status.

These visits may include physical exams, laboratory tests, and imaging performed at scheduled intervals until the study ends or until further follow‑up is no longer required.