Badanie bezpieczeństwa i skuteczności VS-7375 w monoterapii oraz w kombinacji leków u pacjentów z zaawansowanymi nowotworami stałymi KRAS G12D

Baseline Assessment and start of oral vs-7375 monotherapy

After joining the study, baseline examinations are performed, including physical Examination, vital signs, electrocardiogram, laboratory tests and performance status Assessment.

The first medication is vs-7375 taken as a tablet by mouth each day. The exact dose is increased gradually according to the study protocol to find the highest dose that can be tolerated.

Each day the tablet is swallowed with water. No food restrictions are required unless instructed by the study staff.

Regular visits are scheduled to check for side effects, blood test results and any changes in health status.

Vs-7375 dose‑expansion phase (single‑agent)

Once a tolerable dose of vs-7375 is identified, the same daily tablet is continued for a longer period to evaluate its effect on the tumor.

Treatment cycles are defined by the protocol; each cycle may last several weeks, during which the tablet is taken every day.

Periodic assessments (physical exam, blood tests, imaging studies) are performed to monitor tumor response and safety.

Combination dose‑escalation phase

In this phase vs-7375 continues to be taken daily by mouth, while additional medicines are given by intravenous infusion (through a vein).

Possible combination partners are:

Cetuximab – a solution for infusion given on scheduled infusion days,

Carboplatin, pembrolizumab and pemetrexed – each a solution for infusion administered on the same infusion visit,

Gemcitabine and nab‑paclitaxel – given as infusion solutions on the designated infusion days.

The doses of the infusion medicines are increased stepwise according to the study design to determine a safe combination dose.

Patients attend the clinic on infusion days for the intravenous medicines and remain for observation while the infusion is given.

Daily oral vs-7375 is continued throughout the combination cycles.

Combination dose‑expansion phase

After a safe combination dose is identified, the same regimen is given for a longer period to evaluate efficacy.

The regimen may include:

• vs-7375 tablet taken each day together with cetuximab infusion,

• vs-7375 tablet taken each day together with infusions of carboplatin, pembrolizumab and pemetrexed,

• vs-7375 tablet taken each day together with infusions of gemcitabine and nab‑paclitaxel.

Treatment cycles repeat as defined by the protocol, with regular safety and tumor‑response assessments.

Drug‑drug interaction Assessment (ddi) with vs-7375

In this part a fixed dose of vs-7375 (600 mg taken once daily) is given together with medicines that are known to be processed by liver enzymes (for example midazolam or repaglinide).

The purpose is to observe any changes in how these other medicines behave in the body.

Patients continue to take the daily tablet and attend clinic visits for blood sampling to measure drug levels.

Safety monitoring continues throughout this period.