Study on the Safety and Effects of FB849 Alone and with Pembrolizumab in Patients with Advanced Solid Tumors

Program Overview

This study is the first to test FB849 in humans and will take place at multiple centers. It aims to find out how safe and tolerable FB849 is, how it behaves in the body, and its initial effectiveness in treating advanced solid tumors. The study will also explore how FB849 works when combined with pembrolizumab, a standard cancer treatment, in patients who have no other standard therapy available.

Description

The study is divided into four parts:

1. Phase I (Dose-Escalation and Dose-Expansion with FB849 Alone):

   • The first part will gradually increase the dose of FB849 to find the highest dose that patients can tolerate without severe side effects. This part uses a flexible method to adjust doses based on patient reactions.
   • Once a safe dose is found, more patients will receive this dose to further assess its safety and how well it works against tumors.

2. Phase II (FB849 with Pembrolizumab):

   • After the first phase, the study will test FB849 at the safe dose found earlier, combined with pembrolizumab, to see if this combination is safe and effective.
   • Patients will be divided into groups based on their cancer type to evaluate the combination's effects on different cancers.

Throughout the study, patients will be closely monitored for side effects and how their tumors respond to the treatment. Tumor assessments will be done every 6 weeks initially, then every 12 weeks, using scans like CT or MRI. Treatment will continue until the cancer progresses, the patient chooses to stop, or if there are unacceptable side effects.

Eligibility Criteria