drugset / Trial / NCT06953999

A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer

NCT06953999

Phase 3 Recruiting 999 enrolled Akeso
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and/or AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with/without AK117 or placebo, both in combination with chemotherapy.

Timeline

Start
2025-06-11
Primary completion
2027-05-14
Completion
2028-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject AK117 Monoclonal antibody Intravenous
Subject Ivonescimab Monoclonal antibody Intravenous
Background Gemcitabine Small molecule 1000 mg/m2
Background Paclitaxel Small molecule 125 mg/m2