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2025-01-21
2026-12-30
2027-12-30
110
NCT06646055
Akeso
Akeso
INTERVENTIONAL
AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer
This trial is a Phase Ib/II study. All patients are stage IV pancreatic cancer (PDAC) patients with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. The purpose of this study is to evaluate the safety and efficacy of AK112 and Cadonilimab combined with chemotherapy as first-line treatment for patients with metastatic pancreatic cancer.
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 |
|---|---|---|
2024-10-16 | N/A | 2025-01-21 |
2024-10-16 | N/A | 2025-01-23 |
2024-10-17 | N/A | 2025-01 |
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:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Cadonilimab(q4w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib) Cadonilimab will be administered at a selected dose every 4 weeks (q4w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenou | DRUG: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
|
| EXPERIMENTAL: Cadonilimab(q2w) + AK112 + nab-paclitaxel + gemcitabine(phase Ib) Cadonilimab will be administered at a selected dose every 2 weeks (q2w). AK112 will be administed at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenou | DRUG: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
|
| EXPERIMENTAL: Cadonilimab + AK112 + nab-paclitaxel + gemcitabine(phase II) Cadonilimab will be administered at a selected dose and frequency from phase Ib. AK112 will be administered at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, | DRUG: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
|
| EXPERIMENTAL: AK112 + nab-paclitaxel + gemcitabine(phase II) AK112 will be administered at a fixed dose every 2 weeks (q2w). Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively. | DRUG: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
DRUG: AK112, nab-paclitaxel, gemcitabine
|
| ACTIVE_COMPARATOR: nab-paclitaxel + gemcitabine(phase II) Nab-paclitaxel and gemcitabine will be administed at 125mg/m2 d1, d8, d15 q4w, and 1000mg/m2 d1, d8, d15 q4w, intravenously respectively. | DRUG: AK112, Cadonilimab, nab-paclitaxel, gemcitabine
DRUG: AK112, nab-paclitaxel, gemcitabine
DRUG: nab-paclitaxel, gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) and serious adverse events (SAEs) | Frequency of AEs and SAEs for all Arms in phase Ib. | 28days+28days |
| Overall Response Rate (ORR) | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1. | Up to approximately 2 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) | PK parameters: serum concentrations of AK112 and Cadonilimab at different point of time | Up to Cycle 12 |
| Anti-Drug Antibodies(ADAs) | Number and percentage of patients with detectable anti-drug antibodies | Up to approximately 2 years |
| Progression-Free Survival (PFS) | Evaluation of PFS based on RECIST v1.1. | Up to approximately 2 years |
| Overall survival (OS) | Evaluation of OS based on RECIST v1.1. | Up to approximately 2 years |
| Disease control rate (DCR) | Evaluation of DCR based on RECIST v1.1. | Up to approximately 2 years |
| Duration of Response (DoR) | Evaluation of DoR based on RECIST v1.1. | Up to approximately 2 years |
| Time to Response (TTR) | Evaluation of TTR based on RECIST v1.1. | 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, MD Phone Number: +86(0760)89873999 Email: clinicaltrials@akesobio.com |
Study Contact Backup Name: Xianglin Yuan, MD Phone Number: Email: |
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
