Badanie bezpieczeństwa i tolerancji mRNA‑4359 w połączeniu z terapią lekową u pacjentów z zaawansowanymi nowotworami litycznymi

Confirmation of participation and baseline examinations

After joining the study you will undergo a series of initial examinations, including medical history, physical Examination, laboratory tests, and imaging studies to document the extent of the advanced solid tumor.

The results create a baseline that will be used to compare later assessments of safety and tumor response.

First administration of <b>mRNA-4359</b> alone

The investigational product mRNA-4359 is given by intramuscular injection. the exact dose and the volume are specified in the study protocol.

A background injection of sodium chloride (a salt solution) may be administered at the same site to support the procedure.

Initial safety monitoring

Shortly after the first injection you will be observed for vital signs (blood pressure, heart rate, temperature) and for any immediate reactions.

Blood samples are taken to check laboratory values and to identify any early adverse events.

Dose‑escalation phase (arms 1a and 1b)

If you are assigned to the dose‑escalation part of the trial, additional doses of mRNA-4359 are given at increasing levels according to a predefined schedule.

Each dose is administered by intramuscular injection and is followed by safety assessments to determine the maximum tolerated dose (mtd) or the recommended dose for expansion (rde).

Initiation of combination therapy (arms 2a‑2d)

In combination arms you will receive mRNA-4359 together with one or more immune checkpoint inhibitors:

Pembrolizumab – given by intravenous infusion;

Ipilimumab – given by intravenous infusion (used in arm 2C);

Nivolumab – given by intravenous solution for infusion (used in arm 2C).

The dose, frequency (for example every three weeks), and total number of cycles are defined in the study protocol and may continue for several months.

Regular follow‑up visits for safety and tumor Assessment

Throughout the treatment period you will attend scheduled visits where vital signs, laboratory tests, and any side effects are recorded.

Imaging examinations (such as CT or MRI) are performed at defined intervals to evaluate tumor response using the RECIST v1.1 criteria.

Continuation or discontinuation of treatment

Treatment continues until one of the following occurs: disease progression, unacceptable toxicity, completion of the planned number of cycles, or the end of the study period.

If a serious adverse event occurs, the study team may decide to stop the investigational product for safety reasons.

Final study Assessment

At the conclusion of the study you will undergo a final set of examinations, including laboratory tests, imaging, and quality‑of‑life questionnaires.

The collected data will be used to evaluate the safety, tolerability, and antitumor activity of mRNA-4359 alone or in combination with the other agents.