A Multicenter, Open-label, Phase II Umbrella Study to Evaluate the Efficacy and Safety of the Investigational Product in Participants With Advanced or Metastatic Pancreatic Cancer

NCT07814066 | Not Yet Recruiting Phase 2

• 1 other identifier: SKB-PDAC-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, open-label, Phase II umbrella study conducted in participants with advanced or metastatic pancreatic cancer. This study has set up different cohorts to evaluate the efficacy and safety of multiple investigational products in pancreatic cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  Up to approximately 24 months.

Secondary Outcomes (8)

• Progression-free survival (PFS)

  Up to approximately 24 months.

• Duration of Response (DOR)

  Up to approximately 24 months.

• Disease control rate (DCR)

  Up to approximately 24 months.

• Overall Survival (OS)

  Up to approximately 24 months.

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  Up to approximately 24 months.

Study Arms (1)

Cohort A: SKB571 monotherapy

EXPERIMENTAL

Drug: SKB571

Interventions

SKB571 DRUG

q3w

Cohort A: SKB571 monotherapy

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form.
• Histologically or cytologically confirmed advanced or metastatic pancreatic cancer.
• Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before the first dose.
• Participants who have adequate bone marrow, liver, kidney, and coagulation function.
• Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.
• Participants must voluntarily join this study, sign the informed consent form (ICF), and be able to comply with the visits and related procedures specified in the protocol.

You may not qualify if:

• History or current metastases to central nervous system.
• Histologically or cytologically confirmed other pathological types or differentiation combined with other pathological types.
• Subjects with other malignant tumors within 3 years prior to the first dose.
• Presence of any cardiovascular and cerebrovascular disorders or risk factors.
• Presence of uncontrolled systemic disease.
• Presence of clinically symptomatic or uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• History of interstitial lung disease (ILD) or non-infectious pneumonitis.
• Presence within 3 months before the first dose of other moderate to severe lung disorders.
• Tumor invasion or compression of surrounding vital organs and major blood vessels.
• Active severe digestive system diseases.
• Unresolved toxicity from prior anti-tumor therapy.
• Serious infection within 4 weeks before the first dose.
• Presence of active HIV, hepatitis B or hepatitis C or co-infection with HBV and HCV.
• Known history of allogeneic organ transplant or hematopoietic stem cell transplant.
• History of allergy to any component of the study drug or severe hypersensitivity to other monoclonal antibodies.

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-08