Summary
This study is for adults who have metastatic pancreatic cancer (mPDAC) and are also experiencing cachexia, which is severe weight and muscle loss caused by cancer. The study is testing whether a medicine called ponsegromab, given together with standard chemotherapy, can improve outcomes compared with chemotherapy alone.
Everyone in the study will receive standard chemotherapy. The two chemotherapy options are:
- nab-paclitaxel + gemcitabine, or
- FOLFIRINOX (or mFOLFIRINOX)
Before starting the study medicine, participants need to complete 1 cycle of nab-paclitaxel + gemcitabine, or 2 cycles of FOLFIRINIX.
People will then be randomly assigned (by chance) to receive either ponsegromab or a placebo. This will be taken on the same day as the next chemotherapy cycle, and before chemotherapy is given.
The study has two main parts: Phase 2b and Phase 3.
Phase 2b
Participants are randomly assigned to one of three groups:
- Ponsegromab (dose 1) + chemotherapy
- Ponsegromab (dose 2) + chemotherapy
- Placebo + chemotherapy
After 12 weeks, researchers will decide which dose works best.
Phase 3
Only the selected dose of ponsegromab will continue into Phase 3. Participants will be randomly assigned to either:
- The selected ponsegromab dose + chemotherapy
- Placebo + chemotherapy
During Phase 3, caregivers can join an optional sub-study to see whether ponsegromab also helps reduce caregiver burden and improve their wellbeing.