Ivonescimab plus chemotherapy, with or without AK117, for metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: wenting01.li@akesobio.com
• Phone: +86-18116403289

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.