Pancreatic Cancer
Conditions
Brief 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.
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.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response (OS) | Up to approximately 2 years | Overall Survival (OS) is defined as the time from randomization to death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 | Up to approximately 2 years | PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first. |
| Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 | Up to approximately 2 years | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1. |
| Disease Control Rate (DCR) assessed by investigator per RECIST v1.1 | Up to approximately 2 years | Disease control rate (DCR) assessed according to RECIST v1.1. |
| Duration of response (DoR) assessed by the investigator per RECIST v1.1 | Up to approximately 2 years | Duration of response (DoR) assessed according to RECIST v1.1. |
| Time to response (TTR) assessed by the investigator per RECIST v1.1 | Up to approximately 2 years | Time to response (TTR) is defined as the time to response based on RECIST v1.1. |
| Adverse Events (AEs) | Up to approximately 2 years | An AE is any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. |
| Cmax and Cmin | Up to approximately 2 years | AK112 serum drug concentrations in subjects at different time points after AK112 administration. |
| Anti-drug antibodies (ADA) | Up to approximately 2 years | Number of subjects with detectable anti-drug antibodies (ADA). |
Countries
China
Contacts
CONTACTWenting Li
Outcome results
None listed