Pancreatic Cancer MetastaticPhase 1/2NCT07342725
Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer
A Phase 1/2 study testing IBI363 + chemotherapy in people with Pancreatic Cancer Metastatic, run by Ruijin Hospital.
Trial summary
This study is an Ib/II phase clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a second-line treatment for unresectable locally advanced or metastatic pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Metastatic
- What is being tested?
- IBI363 + chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Phase 1/2
- 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
- Signed written informed consent form (ICF)
- Age 18-75 years
- Histologically/cytologically confirmed, unresectable locally advanced or metastatic pancreatic cancer.
- Disease progression or intolerance after first-line treatment with the AG regimen (gemcitabine + albumin-bound paclitaxel).
- ECOG Performance Status(PS) score of 0-1.
- At least one measurable lesion according to RECIST v1.1 criteria.
- Adequate organ and bone marrow function
Who cannot join
- Previous histologically/cytologically confirmed components including adenosquamous carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, etc.
- Prior treatment with PD-1/PD-L1 inhibitors or other immunotherapies.
- Unresolved > Grade 1 toxicities related to prior anticancer therapy (except persistent Grade 2 alopecia, anemia, peripheral neuropathy, correctable electrolyte abnormalities, or well-controlled endocrine disorders with hormone replacement therapy).
- History of hepatic encephalopathy, seizures, active/new/untreated CNS metastases, spinal compression, carcinomatous meningitis, or leptomeningeal metastases.
- Clinically significant cardiovascular/cerebrovascular diseases
- Known hypersensitivity to IL-2, sintilimab, or monoclonal antibody components
About this study
This study is an Ib/II phase clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a second-line treatment for unresectable locally advanced or metastatic pancreatic cancer.
Approximately 39-48 patients with unresectable locally advanced or metastatic pancreatic cancer, who have progressed on or are intolerant to first-line chemotherapy (albumin-bound paclitaxel + gemcitabine, AG regimen), will be enrolled. Treatment involves IBI363 combined with chemotherapy and continues until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for discontinuation.
- Conditions
- Pancreatic Cancer Metastatic
- Being tested
- IBI363 + chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI363 + chemotherapyDrug
IBI363+chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: IBI363 + chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: Up to approximately 36 months
Progression-Free Survival(PFS)
Measured: Up to approximately 6 months
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: Up to approximately 6 months
Disease control rate(DCR)
Measured: Up to approximately 6 months
Overall Survival(OS)
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovent Biologics, Inc.
- Responsible party
- Principal investigator, BAIYONG SHEN, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342725
- Sponsor's protocol ID
- PANC-IBI363
- Status last verified
- Jan 2026
- First submitted
- 24 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07342725
- Acronym / sponsor ID
- PANC-IBI363
- Conditions
- Pancreatic Cancer Metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Innovent Biologics, Inc.
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jan 2026 (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 an Ib/II phase clinical trial evaluating the safety and efficacy of IBI363 combined with chemotherapy as a second-line treatment for unresectable locally advanced or metastatic pancreatic cancer.
Approximately 39-48 patients with unresectable locally advanced or metastatic pancreatic cancer, who have progressed on or are intolerant to first-line chemotherapy (albumin-bound paclitaxel + gemcitabine, AG regimen), will be enrolled. Treatment involves IBI363 combined with chemotherapy and continues until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, or other protocol-specified reasons for discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: IBI363 + chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written informed consent form (ICF)
- Age 18-75 years
- Histologically/cytologically confirmed, unresectable locally advanced or metastatic pancreatic cancer.
- Disease progression or intolerance after first-line treatment with the AG regimen (gemcitabine + albumin-bound paclitaxel).
- ECOG Performance Status(PS) score of 0-1.
Key exclusion criteria (6 listed)
- Previous histologically/cytologically confirmed components including adenosquamous carcinoma, medullary carcinoma, signet ring cell carcinoma, undifferentiated carcinoma, etc.
- Prior treatment with PD-1/PD-L1 inhibitors or other immunotherapies.
- Unresolved > Grade 1 toxicities related to prior anticancer therapy (except persistent Grade 2 alopecia, anemia, peripheral neuropathy, correctable electrolyte abnormalities, or well-controlled endocrine disorders with hormone replacement therapy).
- History of hepatic encephalopathy, seizures, active/new/untreated CNS metastases, spinal compression, carcinomatous meningitis, or leptomeningeal metastases.
- Clinically significant cardiovascular/cerebrovascular diseases
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 |
|---|---|---|
| IBI363 + chemotherapyIBI363+chemotherapy | Drug | Experimental Group |
Primary outcome
Adverse events (AEs)
Time frame: Up to approximately 36 months
Progression-Free Survival(PFS)
Time frame: Up to approximately 6 months
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 6 months
Disease control rate(DCR)
Time frame: Up to approximately 6 months
Overall Survival(OS)
Time frame: Up to approximately 12 months
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 15 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IBI363 + chemotherapy in people with Pancreatic Cancer Metastatic, run by Ruijin Hospital.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: Up to approximately 36 months). 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 15 Jan 2026; AzTrials last refreshed its copy on 30 Oct 2026.