Pancreatic CancerPhase 3NCT06953999
A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer
A Phase 3 study testing Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine in people with Pancreatic Cancer, run by Akeso at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 999 participants
- Where
- 3 sitesChina
- Study dates
- 11 Jun 2025to 14 May 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Jieer Ying, MD, 0571-88122062, hzyingjieer@163.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Sheng Tai, MD, 0451-86298911, taisheng1973@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 20032
Xianjun Yu, MD, 021-64175590, yuxianjun@fudanpci.org
About this study
Official title: A Randomized, Controlled, Multi-center Phase III Clinical Study of Ivonescimab Plus Chemotherapy With or Without AK117 Versus Placebo Combined With Chemotherapy as First-line Treatment for 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine, Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine, Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivonescimab, AK117, Albumin-bound Paclitaxel, GemcitabineDrug
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.
Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, GemcitabineDrug
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.
Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, GemcitabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine | Experimental | Not described Receives: Drug: Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine |
| Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine | Experimental | Not described Receives: Drug: Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine |
| Ivonescimab Placebo + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine | Active comparator | Not described Receives: Drug: Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response (OS)
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 2 years
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 2 years
Cmax and Cmin
AK112 serum drug concentrations in subjects at different time points after AK112 administration.
Measured: Up to approximately 2 years
Anti-drug antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start11 Jun 2025
- Primary completion14 May 2027 (estimated)
- Study completion14 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 999 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953999
- Sponsor's protocol ID
- AK112-310
- Status last verified
- Mar 2026
- First submitted
- 24 Apr 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-center Phase III Clinical Study of Ivonescimab Plus Chemotherapy With or Without AK117 Versus Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06953999
- Acronym / sponsor ID
- AK112-310
- Conditions
- Pancreatic Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 999 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 14 May 2027 (estimated)
- Study completion
- 14 May 2028 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine | Experimental | Drug: Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine |
| Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine | Experimental | Drug: Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine |
| Ivonescimab Placebo + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine | Active comparator | Drug: Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivonescimab, AK117, Albumin-bound Paclitaxel, GemcitabineIvonescimab: 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. | Drug | Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine |
| Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, GemcitabineIvonescimab: 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. | Drug | Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine |
| Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, GemcitabineIvonescimab 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. | Drug | Ivonescimab Placebo + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine |
Primary outcome
Overall response (OS)
Time frame: Up to approximately 2 years
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
8 secondary outcomes
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Duration of response (DoR) assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Time to response (TTR) assessed by the investigator per RECIST v1.1
Time frame: Up to approximately 2 years
Adverse Events (AEs)
Time frame: Up to approximately 2 years
Cmax and Cmin
Time frame: Up to approximately 2 years
Anti-drug antibodies (ADA)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine in people with Pancreatic Cancer, run by Akeso at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenting Li (+86-18116403289, wenting01.li@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response (OS) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.