RecruitingPhase 3NCT06953999

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

A Randomized, Controlled, Multi-center Phase III Clinical Study of Ivonescimab Plus Chemotherapy With or Without AK117 Versus Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer

Sponsor

Akeso

Enrollment

999 participants

Start Date

Jun 11, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a drug called AK117 (an anti-CD47 antibody) to a combination of ivonescimab (a dual immunotherapy drug) and chemotherapy improves outcomes for people with metastatic pancreatic cancer that has not been treated before. Pancreatic cancer is hard to treat, and researchers are looking for new combinations that can help the immune system fight the disease. **You may be eligible if...** - You are between 18 and 75 years old with metastatic pancreatic ductal adenocarcinoma confirmed by biopsy - You have not received any prior treatment for your metastatic disease - You have at least one measurable tumor on imaging - You are in good general health **You may NOT be eligible if...** - You have brain metastases (cancer spread to the brain that is active) - You carry a BRCA1/2 or PALB2 gene mutation - You have significant fluid buildup in your chest, around the heart, or in the abdomen - You have had another cancer in the past 5 years - You have an active autoimmune disease requiring treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIvonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine

Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.

DRUGIvonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.

DRUGIvonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

Ivonescimab Placebo : a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo : a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.