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2025-05-14
2027-05-14
2028-05-14
999
NCT06953999
Akeso
Akeso
INTERVENTIONAL
A Phase III Study of Ivonescimab + Chemo With/Without AK117 vs Chemo in Metastatic Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-04-24 | N/A | 2025-04-24 |
2025-04-24 | N/A | 2025-05-01 |
2025-05-01 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Quadruple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine | DRUG: Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine
|
| EXPERIMENTAL: Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine | DRUG: Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
|
| ACTIVE_COMPARATOR: Ivonescimab Placebo + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine | DRUG: Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall response (OS) | Overall Survival (OS) is defined as the time from randomization to death due to any cause. | Up to approximately 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) assessed by investigator per RECIST v1.1 | 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. | Up to approximately 2 years |
| Objective Response Rate (ORR) assessed by investigator per RECIST v1.1 | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1. | Up to approximately 2 years |
| Disease Control Rate (DCR) assessed by investigator per RECIST v1.1 | Disease control rate (DCR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| Duration of response (DoR) assessed by the investigator per RECIST v1.1 | Duration of response (DoR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| Time to response (TTR) assessed by the investigator per RECIST v1.1 | Time to response (TTR) is defined as the time to response based on RECIST v1.1. | Up to approximately 2 years |
| Adverse Events (AEs) | 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. | Up to approximately 2 years |
| Cmax and Cmin | AK112 serum drug concentrations in subjects at different time points after AK112 administration. | Up to approximately 2 years |
| Anti-drug antibodies (ADA) | Number of subjects with detectable anti-drug antibodies (ADA). | Up to approximately 2 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Wenting Li Phone Number: +86-18116403289 Email: wenting01.li@akesobio.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
