Bezpieczeństwo i skuteczność AZD6621 u dorosłych mężczyzn z przerzutowym rakiem prostaty

Baseline assessments

After signing the consent form, a complete medical history is taken, a physical Examination is performed, and blood tests are done to check organ function and prostate‑specific antigen (PSA) levels.

Imaging studies such as CT or MRI are performed to document the extent of metastatic prostate cancer.

First treatment visit

The study drug AZD6621 is prepared from a powder for concentrate for injection/infusion and given by intravenous infusion according to the study schedule.

The infusion is performed in a clinical setting where vital signs are monitored before, during, and after the administration.

Post‑infusion monitoring

After the infusion, vital signs, laboratory results and any symptoms are checked for several hours to detect immediate side effects.

If any adverse reaction occurs, appropriate medical care is provided.

Subsequent treatment cycles

Additional infusions of AZD6621 are given on the dates defined by the study protocol (for example weekly or every two weeks).

Each cycle is preceded by a Brief clinical Assessment and laboratory tests to ensure safety before the next infusion.

Dose escalation evaluation (part a)

During the early part of the study, the dose may be increased stepwise if previous doses are well tolerated.

The research team looks for dose limiting toxicity – side effects that are severe enough to stop increasing the dose.

The maximum dose that can be given safely (maximum tolerated dose) is identified based on these observations.

Recommended dose determination

Once the maximum tolerated dose is known, a recommended dose for further participants is set.

Patients who continue in the study receive the drug at this recommended dose.

Dose expansion phase (part B)

Participants receive the recommended dose of AZD6621 as monotherapy or in combination with other allowed treatments.

The same monitoring procedures as in earlier cycles are followed.

Regular efficacy assessments

Periodic blood tests measure PSA levels to evaluate tumor response.

Imaging studies are repeated according to the schedule to assess changes in tumor size.

These results help determine whether the treatment is having an anti‑tumor effect.

Treatment discontinuation Criteria

Treatment may be stopped if disease progression is observed, if unacceptable toxicity occurs, or if the study reaches its planned end date.

Post‑treatment follow‑up

After the last infusion, follow‑up visits continue for a defined period to monitor long‑term safety and any delayed effects.

Blood tests, PSA measurements and occasional imaging are performed during this follow‑up.