A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer
Recruiting · NCT06953999 · Interventional (participants receive a specific treatment) · Lead sponsor: Akeso
View the official record on ClinicalTrials.gov →Interventions studied
Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, GemcitabineIvonescimab, AK117 Placebo, Albumin-bound Paclitaxel, GemcitabineIvonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Voluntarily sign a written informed consent form.
- Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 3 months.
- Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).
- No prior systemic anti-cancer treatment for metastatic PDAC.
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Adequate organ function.
Exclusion criteria
- Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types.
- Presence of active central nerve system (CNS) metastases.
- Known germline BRCA1/2 or PALB2 mutations.
- Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
- History of other malignancies within the past 5 years.
- History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.
- Previous anti-angiogenic therapy and immunotherapy.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- Pregnant or breastfeeding women.
- 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 is running
3 locations listed.
- Harbin Medical University Cancer Hospital - Harbin, Heilongjiang, China
- Fudan University Shanghai Cancer Center - Shanghai, Shanghai Municipality, China
- Zhejiang Cancer Hospital - Hangzhou, Zhejiang, China