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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: SKB571

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
• Participants who have received other investigational drug treatments within 4 weeks before the first dose.
• Pregnant or breastfeeding women.
• Known history of psychosis or drug abuse that prevents the participant from cooperating with the study.
• Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which may lead to higher medical risk and/or uncertainty in survival assessment, or may affect protocol compliance.
• Any condition that, in the investigator's opinion, interferes with the evaluation of the investigational product, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: SKB571 monotherapy	Drug: SKB571; q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Time from start of treatment to progression of disease (PD) or death, whichever occurs first, in patients with tumors.	Up to approximately 24 months.
Duration of Response (DOR)	Time from the start of the first assessment of CR or PR in tumor patients to PD or death due to any reason.	Up to approximately 24 months.
Disease control rate (DCR)	Assessed by the investigators as per RECIST v1.1	Up to approximately 24 months.
Overall Survival (OS)	Time from start of treatment to death due to any reason.	Up to approximately 24 months.
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results.	Up to approximately 24 months.
Maximum Plasma Concentration (Cmax) of the investigational product	Blood Samples will be collected to determine the Cmax of the investigational product in the plasma.	Up to approximately 24 months.
Minimum Plasma Concentration (Cmin) of the investigational product	Blood Samples will be collected to determine the Cmin of the investigational product in the plasma.	Up to approximately 24 months.
Immunogenicity of the investigational product	Incidence of anti-drug antibody (ADA) against the investigational product.	Up to approximately 24 months.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 7, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: SKB-PDAC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No