A Study to Find a Safe Dose of TD001 for Patients with Metastatic Castration-Resistant Prostate Cancer that Expresses PSMA

Initial treatment period

The trial involves receiving TD001, which is an investigational medication designed to target a protein called PSMA that is found on prostate cancer cells.

TD001 is given as an infusion, meaning it is administered directly into a vein over a period of time.

The treatment is organized in cycles. Each cycle represents a specific period during which the medication is given and monitored.

Dose escalation phase

During this phase, the dose of TD001 is carefully adjusted to find a safe and effective amount.

The first cycle is particularly important for monitoring how the body responds to the medication.

Different administration schedules may be tested to determine the best way to give the medication.

Safety and tolerability are closely monitored throughout this phase to identify the maximum tolerated dose, which is the highest dose that does not cause unacceptable side effects, and the recommended phase 2 dose, which is the dose selected for further testing.

Dose expansion phase

Once a safe and appropriate dose has been identified in the escalation phase, this dose is given to additional participants.

The same infusion method is used, with TD001 administered directly into a vein.

The focus during this phase is to further evaluate the safety and tolerability of the selected dose and administration schedule.

Ongoing monitoring and assessments

Throughout the trial, regular monitoring takes place to assess how the treatment is affecting the disease and the body.

Blood tests are performed to measure PSA levels. PSA is a protein produced by prostate cells, and changes in PSA levels can indicate how the cancer is responding to treatment.

Imaging scans may be performed to evaluate whether tumors in soft tissue, organs, or bones are growing, shrinking, or remaining stable.

Blood samples are collected to measure the levels of TD001 in the bloodstream and to understand how the body processes the medication.

Safety is continuously assessed by monitoring for any side effects or adverse events, including laboratory tests to check organ function and overall health.

Response evaluation

The response to treatment is evaluated using specific criteria to determine if the cancer is responding to TD001.

A PSA50 response refers to a reduction of at least 50 percent in PSA levels from the starting point.

Tumor response is assessed using imaging studies to see if measurable tumors have decreased in size.

Disease control includes situations where the cancer is either shrinking or remaining stable without growing.

The time during which the disease does not progress is measured, both in terms of PSA levels and imaging findings.

Long-term follow-up

Participants continue to be monitored over an extended period to assess the duration of any positive responses to treatment.

Overall survival, which is the length of time participants remain alive, is tracked as part of the trial.

Blood tests may be performed to check for the development of anti-drug antibodies, which are proteins the immune system might produce in response to TD001.