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

NCT ID: NCT07342725

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-12-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

Group Type: EXPERIMENTAL

IBI363 + chemotherapy

Intervention Type: DRUG

IBI363+chemotherapy

Interventions

IBI363 + chemotherapy

IBI363+chemotherapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics, Inc.

OTHER

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

BAIYONG SHEN

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PANC-IBI363

Identifier Type: -

Identifier Source: org_study_id