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NCT Number: NCT07342725

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

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.

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Key information

Conditions

Pancreatic Cancer Metastatic

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBI363 + chemotherapy

Drug

IBI363+chemotherapy

Primary outcomes

  1. Adverse events (AEs)

    Time frame: Up to approximately 36 months

  2. Progression-Free Survival(PFS)

    Time frame: Up to approximately 6 months

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to approximately 6 months

  2. Disease control rate(DCR)

    Time frame: Up to approximately 6 months

  3. Overall Survival(OS)

    Time frame: Up to approximately 12 months

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Innovent Biologics, Inc.

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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