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

NCT06953999 · tracked via the Priya Life Science China tracker

Sponsor

Akeso

Phase

Phase 3

Started

2025-06-11

Last updated

2026-03-04

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

Ivonescimab, AK117, Albumin-bound Paclitaxel, GemcitabineIvonescimab, AK117 Placebo, Albumin-bound Paclitaxel, GemcitabineIvonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

Ivonescimab, 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.

Ivonescimab, 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.

Ivonescimab 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Voluntarily sign a written informed consent form. 2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy of ≥ 3 months. 5. Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC). 6. No prior systemic anti-cancer treatment for metastatic PDAC. 7. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 8. Adequate organ function. Exclusion Criteria: 1. Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types. 2. Presence of active central nerve system (CNS) metastases. 3. Known germline BRCA1/2 or PALB2 mutations. 4. Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage. 5. History of other malignancies within the past 5 years. 6. History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose. 7. Previous anti-angiogenic therapy and immunotherapy. 8. Active autoimmune disease requiring systemic treatment within the past 2 years. 9. Pregnant or breastfeeding women. 10. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.

Primary outcome measure(s)

Overall response (OS) — Up to approximately 2 years
Overall Survival (OS) is defined as the time from randomization to death due to any cause.

Trial sites (3)

Facility	City	Region	Status
Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	Recruiting
Fudan University Shanghai Cancer Center	Shanghai	Shanghai Municipality	Recruiting
Zhejiang Cancer Hospital	Hangzhou	Zhejiang	Recruiting

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A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Breast Cancer Starting soon

A Study of AK138D1 in Advanced Malignant Tumors Recruiting

AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment Starting soon

Other trials for the same condition

Stereotactic Body Radiotherapy and NALIRIFOX for Locally Advanced Pancreatic Cancer Active, not recruiting

Albumin-bound Paclitaxel Combined With Gemcitabine First-line Inoperable Pancreatic Cancer Recruiting

A Prospective Study of Liquid Biopsy for Pancreatic Cancer Early Detection Recruiting

Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI) Recruiting

The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Pancreatic Cancer. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06953999 on ClinicalTrials.gov ↗ ← All trials in China