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

January 14, 2026 updated by: BAIYONG SHEN, Ruijin Hospital

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 2
  • Phase 1

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Drug: IBI363 + chemotherapy
IBI363+chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: Up to approximately 36 months
Up to approximately 36 months
Progression-Free Survival(PFS)
Time Frame: Up to approximately 6 months
Up to approximately 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 6 months
Up to approximately 6 months
Disease control rate(DCR)
Time Frame: Up to approximately 6 months
Up to approximately 6 months
Overall Survival(OS)
Time Frame: Up to approximately 12 months
Up to approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Innovent Biologics, Inc.

Study record dates

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 Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANC-IBI363

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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