Study on Ponsegromab for Adults with Advanced Pancreatic Cancer and Significant Weight Loss and Fatigue

Program Overview

The study aims to find out if adding ponsegromab to standard chemotherapy can improve outcomes for adults with advanced pancreatic cancer that has spread and caused significant weight loss and fatigue. Participants will receive either ponsegromab or a placebo along with their chemotherapy treatment to see if it helps manage their condition better.

Description

This study is divided into two phases: Phase 2b and Phase 3. It involves testing a new drug, ponsegromab, in combination with standard chemotherapy for adults with advanced pancreatic cancer. The chemotherapy options include nab-paclitaxel with gemcitabine or FOLFIRINOX. Participants will be randomly assigned to receive either ponsegromab or a placebo along with their chemotherapy.

In Phase 2b, participants will be divided into groups to receive one of two doses of ponsegromab or a placebo. After completing the initial chemotherapy cycle, they will start the study treatment on the same day as their next chemotherapy cycle. The study treatment is given as an injection every four weeks.

Once Phase 2b is complete, the study will move to Phase 3, where the most effective dose of ponsegromab will be selected. Participants will continue with the selected dose or switch to it if they were on a different dose. Those on placebo will continue with placebo. The study will remain blinded, meaning participants won't know if they are receiving ponsegromab or placebo.

During Phase 3, there is an optional sub-study for caregivers to see if ponsegromab improves their quality of life. Participants will continue the study treatment until they choose to stop, the study ends, or they can no longer participate. Tumor assessments will be done every 6 to 8 weeks.

After the main study ends, participants can join an open-label extension to receive ponsegromab for up to 12 months.

Eligibility Criteria

Locations