Pancreatic CancerPhase 2NCT05859750
A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer
A Phase 2 study testing AK104, Gemcitabine and Nab-Paclitaxel in people with Pancreatic Cancer, run by Akeso at 7 sites in China.
Trial summary
This study is a multicenter, open-label, phase II study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line therapy in subjects with advanced unresectable… 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?
- AK104, Gemcitabine and Nab-Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 7 sitesChina
- Study dates
- 25 May 2023to Dec 2025
- Phase
- Phase 2
- 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
- Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- Males or females aged ≥ 18 years and ≤ 75 years at the time of signing the ICF.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Patients have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer; for patients who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant/neoadjuvant chemotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
- Patients have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression as judged by imaging, it can be considered as a target lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Expected survival ≥ 3 months.
- Patients who have adequate organ function.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose. Male patients with female partners of childbearing potential must agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.
Who cannot join
- Histologically or cytologically confirmed other pathological types, such as acinar cell carcinoma, pancreatic neuroendocrine neoplasms or pancreatoblastoma.
- Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
- Patients with known germ line BRAC1/2 mutation.
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
- Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
- Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors.
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- Major surgery other than the diagnosis of pancreatic cancer within 28 days prior to the first dose or major surgery is expected during the study.
- Pregnant or lactating women.
- Patients who received any prior treatments targeting the mechanism of tumor immunity.
- Patients with known contraindications to prescribed chemotherapy regimen (see instructions for specific drug).
- Patients with known medical history of severe hypersensitivity reactions to other monoclonal antibodies or intravenous gamma globulin.
- Active autoimmune disease within 2 years prior to the start of study treatmen.
- Known active pulmonary tuberculosis.
- Patients with active hepatitis B or active hepatitis C.
- Known medical history of immunodeficiency or positive HIV test.
- Patients with active infection.
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Concurrent participation in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study.
- Any condition that, in the opinion of the Investigator, may result in a risk when receiving the study drug, or would interfere with the evaluation of the study drug or the safety of patients, or the interpretation of the study results.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Wenming Wu, MD
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Zhihua Li, MD
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Qi Xu, MD
- Recruiting
Zhejiang Provincial People's hospital
Hangzhou, Zhejiang
Yiping Mou, MD
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
He Tian, MD
- Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Gang Jin, MD
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science And Technology
Wuhan, Hubei
Heshui Wu, MD
About this study
Official title: A Multicenter, Open-label, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Combination With Chemotherapy as First-line Treatment in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
This study is a multicenter, open-label, phase II study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line therapy in subjects with advanced unresectable or metastatic pancreatic ductal adenocarcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- AK104, Gemcitabine, Nab-Paclitaxel, Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate, Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104Drug
AK104 (6mg/kg) on day 1, IV, Q2W
AK104Drug
AK104 (10mg/kg) on day 1, IV, Q2W
GemcitabineDrug
Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W
Nab-PaclitaxelDrug
Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W
Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinateDrug
liposomal irinotecan 50 mg/m², oxaliplatin 60 mg/m², leucovorin 400 mg/m², and fluorouracil 2400 mg/m², administered sequentially as a continuous intravenous infusion over 46 h
Oxaliplatin + Irinotecan + 5-Fluorouracil/LeucovorinDrug
oxaliplatin, 85 mg/m²; irinotecan, 180 mg/m²; leucovorin, 400 mg/m²; and fluorouracil, 400 mg/m² given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| AK104 6mg/kg and AG | Experimental | Not described Receives: Drug: AK104; Drug: Gemcitabine; Drug: Nab-Paclitaxel |
| AK104 10mg/kg and AG | Experimental | Not described Receives: Drug: AK104; Drug: Gemcitabine; Drug: Nab-Paclitaxel |
| AK104 and mFOLFIRINOX | Experimental | Not described Receives: Drug: AK104; Drug: Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin |
| AK104 and NALIRIFOX | Experimental | Not described Receives: Drug: AK104; Drug: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is the proportion of subjects with CR or PR based on RECIST v1.1
Measured: Up to 2 years
The number of subjects experiencing adverse events (AEs)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
Measured: From the subject signs the ICF to 90 days after the last dose of study treatment.
Secondary outcomes (4)
Maximum observed concentration (Cmax) of AK104
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
Measured: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Minimum observed concentration (Cmin) of AK104 at steady state
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
Measured: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Area under the curve (AUC) of AK104
The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
Measured: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).
Measured: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start25 May 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859750
- Sponsor's protocol ID
- AK104-217
- Status last verified
- Dec 2024
- First submitted
- 14 Apr 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Combination With Chemotherapy as First-line Treatment in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05859750
- Acronym / sponsor ID
- AK104-217
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 25 May 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 May 2023 (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 study is a multicenter, open-label, phase II study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line therapy in subjects with advanced unresectable or metastatic pancreatic ductal adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AK104 6mg/kg and AG | Experimental | Drug: AK104, Drug: Gemcitabine, Drug: Nab-Paclitaxel |
| AK104 10mg/kg and AG | Experimental | Drug: AK104, Drug: Gemcitabine, Drug: Nab-Paclitaxel |
| AK104 and mFOLFIRINOX | Experimental | Drug: AK104, Drug: Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin |
| AK104 and NALIRIFOX | Experimental | Drug: AK104, Drug: Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
- Males or females aged ≥ 18 years and ≤ 75 years at the time of signing the ICF.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Patients have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer; for patients who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant/neoadjuvant chemotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months.
- Patients have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression as judged by imaging, it can be considered as a target lesion.
Key exclusion criteria (19 listed)
- Histologically or cytologically confirmed other pathological types, such as acinar cell carcinoma, pancreatic neuroendocrine neoplasms or pancreatoblastoma.
- Known active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal disease.
- Patients with known germ line BRAC1/2 mutation.
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).
- Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.
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 |
|---|---|---|
| AK104AK104 (6mg/kg) on day 1, IV, Q2W | Drug | AK104 6mg/kg and AG, AK104 and NALIRIFOX, AK104 and mFOLFIRINOX |
| AK104AK104 (10mg/kg) on day 1, IV, Q2W | Drug | AK104 10mg/kg and AG, AK104 and NALIRIFOX, AK104 and mFOLFIRINOX |
| GemcitabineGemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W | Drug | AK104 10mg/kg and AG, AK104 6mg/kg and AG |
| Nab-PaclitaxelNab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W | Drug | AK104 10mg/kg and AG, AK104 6mg/kg and AG |
| Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinateliposomal irinotecan 50 mg/m², oxaliplatin 60 mg/m², leucovorin 400 mg/m², and fluorouracil 2400 mg/m², administered sequentially as a continuous intravenous infusion over 46 h | Drug | AK104 and NALIRIFOX |
| Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorinoxaliplatin, 85 mg/m²; irinotecan, 180 mg/m²; leucovorin, 400 mg/m²; and fluorouracil, 400 mg/m² given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks | Drug | AK104 and mFOLFIRINOX |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 2 years
ORR is the proportion of subjects with CR or PR based on RECIST v1.1
The number of subjects experiencing adverse events (AEs)
Time frame: From the subject signs the ICF to 90 days after the last dose of study treatment.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
4 secondary outcomes
Maximum observed concentration (Cmax) of AK104
Time frame: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Minimum observed concentration (Cmin) of AK104 at steady state
Time frame: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Area under the curve (AUC) of AK104
Time frame: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of study drug until the 8th cycle (each cycle is 28 days) of study drug administration.
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 16 Dec 2024.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104, Gemcitabine and Nab-Paclitaxel in people with Pancreatic Cancer, run by Akeso at 7 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 9 inclusion and 19 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 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Zhifang Yao, MD (+86-0760-89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 16 Dec 2024.