Ivonescimab plus chemotherapy, with or without AK117, for 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

This trial will test whether adding the antibody Ivonescimab, with or without AK117, to standard chemotherapy helps people with metastatic pancreatic cancer live longer or have better tumor responses.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 999 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Akeso (industry)
• Drugs / interventions: immunotherapy, Ivonescimab, chemotherapy
• Locations: 3 sites (Harbin, Heilongjiang and 2 other locations)
• Trial ID: NCT06953999 on ClinicalTrials.gov

What this trial studies

This Phase III, randomized, double-blind trial compares Ivonescimab plus gemcitabine and albumin-bound paclitaxel, with or without AK117, against placebo plus the same chemotherapy in patients with unresectable metastatic pancreatic ductal adenocarcinoma. Eligible patients are treatment-naïve for metastatic disease, have measurable lesions per RECIST v1.1, and an ECOG performance status of 0–1. Participants are randomly assigned to experimental or placebo arms and followed for efficacy and safety outcomes including overall survival, progression-free survival, response rate, and adverse events. The study is conducted at multiple centers in China under blinded conditions to minimize bias.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 with histologically confirmed unresectable metastatic pancreatic ductal adenocarcinoma, ECOG 0–1, measurable disease, adequate organ function, and no prior systemic therapy for metastatic disease.

Not a fit: Patients with other pancreatic tumor types, active CNS metastases, known germline BRCA1/2 or PALB2 mutations, recent other cancers, significant effusions, or poor performance status are unlikely to be eligible or benefit from this protocol.

Why it matters

Potential benefit: If successful, the combination could extend survival or increase response rates compared with chemotherapy alone for patients with metastatic pancreatic cancer.

How similar studies have performed: While some early-phase trials of immune-targeting antibodies have shown signals, no antibody added to standard chemotherapy has yet produced definitive phase III success in metastatic pancreatic cancer, making this approach promising but unproven.

Eligibility criteria

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.

Where this trial is running

Harbin, Heilongjiang and 2 other locations

• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (RECRUITING)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Wenting Li

Conditions: Pancreatic Cancer