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

NCT07342725 | Not Yet Recruiting Phase 1

• 1 other identifier: PANC-IBI363
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs)

  Up to approximately 36 months

• Progression-Free Survival(PFS)

  Up to approximately 6 months

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Up to approximately 6 months

• Disease control rate(DCR)

  Up to approximately 6 months

• Overall Survival(OS)

  Up to approximately 12 months

Study Arms (1)

Experimental Group

EXPERIMENTAL

Drug: IBI363 + chemotherapy

Interventions

IBI363 + chemotherapy DRUG

IBI363+chemotherapy

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innovent Biologics, Inc.: collaborator
• Ruijin Hospital: lead

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01