JDB153 Combined With Serplulimab For Pancreatic Cancer After Standard Treatment Failure

Study Overview

JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure

The goal of this clinical trial is to evaluate the safety and efficacy of JDB153 combined with Serplulimab in patients with pancreatic cancer after standard treatment failure.

This study is a single-arm, single-center, exploratory clinical trial aimed at evaluating the safety and efficacy of JDB153 combined with Serplulimab in patients with pancreatic cancer after standard treatment failure.

Refractory Pancreatic Ductal Adenocarcinoma
Refractory Pancreatic Adenocarcinoma

DRUG: JDB153
DRUG: Serplulimab

JDB153-IIT-PDAC002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-09-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-09-09
First Submitted that Met QC Criteria 2025-09-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2025-09-16
First Posted (ESTIMATED) 2025-09-16	Results First Posted N/A	Last Verified 2025-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: JDB153 combined with Serplulimab	DRUG: JDB153 JDB153 is administered orally at doses of 600 mg twice daily (1200 mg total daily dose) or 500 mg twice daily (1000 mg total daily dose) based on safety and tolerability assessment. DRUG: Serplulimab Serplulimab is administered by intravenous infusion at a dose of 200 mg once every 3 weeks (Q3W).

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: JDB153 combined with Serplulimab

DRUG: JDB153

JDB153 is administered orally at doses of 600 mg twice daily (1200 mg total daily dose) or 500 mg twice daily (1000 mg total daily dose) based on safety and tolerability assessment.

DRUG: Serplulimab

Serplulimab is administered by intravenous infusion at a dose of 200 mg once every 3 weeks (Q3W).

Primary Outcome Measures	Measure Description	Time Frame
Incidence of Treatment-Related Adverse Events	Number of participants experiencing treatment-related adverse events, serious adverse events, dose-limiting toxicities, and adverse events leading to treatment discontinuation, graded according to NCI CTCAE v5.0	Approximately 2 years
Objective Response Rate (ORR)	Proportion of participants achieving complete response (CR) and partial response (PR) according to RECIST v1.1 criteria	Approximately 2 years

Secondary Outcome Measures	Measure Description	Time Frame
Disease Control Rate (DCR)	Proportion of participants achieving complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 criteria	Approximately 2 years
Duration of Response (DoR)	Time from first documented objective response (CR or PR) to disease progression or death from any cause, whichever occurs first, according to RECIST v1.1 criteria	Approximately 2 years
Time to Progression (TTP)	Time from study enrollment to disease progression according to RECIST v1.1 criteria	Approximately 2 years
Progression-Free Survival (PFS)	Time from study enrollment to disease progression or death from any cause, whichever occurs first, according to RECIST v1.1 criteria	Approximately 2 years
Overall Survival (OS)	Time from study enrollment to death from any cause	Approximately 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dan Cao, MD

Phone Number: +8618980605963

Email: caodan@scu.edu.cn

Study Contact Backup

Name: Hong Zhu, MD

Phone Number: +8615828320185

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

1) Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic pancreatic cancer; 2) Age 18-75 years, inclusive; no sex restrictions; 3) Life expectancy ≥12 weeks; 4) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 5) Documented disease progression following prior standard systemic therapy. For patients who experienced disease progression within 6 months during or after adjuvant chemotherapy, the adjuvant chemotherapy will be considered first-line treatment; 6) Presence of at least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Target lesions must have a maximum diameter of ≥1 cm if identified by helical computed tomography (CT) or ≥2 cm if identified by conventional CT or magnetic resonance imaging (MRI). All imaging must have been performed within 28 days prior to enrollment; 7) Adequate bone marrow and organ function, as evidenced by laboratory test results obtained within 1 week prior to enrollment: Hemoglobin ≥90 g/L; Platelet count ≥75 × 10⁹/L; White blood cell count ≥3.0 × 10⁹/L; Absolute neutrophil count ≥1.5 × 10⁹/L; Total bilirubin ≤1.5 × upper limit of normal (ULN)(or ≤ 3.0 × ULN for patients with documented liver metastases); Serum creatinine ≤1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (or ≤ 5.0 × ULN for patients with documented liver metastases). Patients must not have received blood transfusions, granulocyte colony-stimulating factor (G-CSF), or other medical supportive treatments within 14 days prior to study drug administration; 8) Voluntary participation with provision of written informed consent.

1) History of other malignant tumors with disease-free survival <5 years (except cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and gastrointestinal tumors confirmed to be cured by endoscopic mucosal resection); 2) Prior treatment with a PD-1or PD-L1inhibitor; 3) Presence of immunodeficiency disease or HIV infection; 4) Severe, uncontrolled acute infection (defined as fever >38°C caused by infection); 5) History of active hepatitis B or active hepatitis C, defined as: HBV DNA titer ≥2000 IU/mL (or 1×10⁴ copies/mL) or HCV RNA ≥lower limit of detection; 6) Severe hepatic or renal dysfunction; or recent history of myocardial infarction (within 3 months); 7) Patients with active or previous autoimmune disease that has the potential for recurrence or poses associated risks (e.g., those who have undergone organ transplantation requiring immunosuppressive therapy). However, patients with Type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, or skin diseases not necessitating systemic treatment (e.g., vitiligo, psoriasis, or alopecia) are permitted to enroll; 8) History of interstitial lung disease or non-infectious pneumonitis that is symptomatic or has a history of pulmonary disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity; 9) History of active tuberculosis infection within 1 year prior to first administration of study drug. However, for patients with a history of active tuberculosis infection more than 1 year ago, enrollment is considered appropriate if the investigator determines there is currently no evidence of active tuberculosis; 10) History of chronic diarrhea or presence of complete intestinal obstruction; 11) Patients requiring systemic treatment with corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days prior to administration of study drug. Note: Inhaled or topical steroids, or adrenal replacement therapy (≤10 mg/day prednisone equivalent), are permitted in the absence of active autoimmune disease. Short-term (≤7 days) use of corticosteroids for prophylactic treatment (e.g., contrast media allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reactions caused by contact allergens) is permitted; 12) Concurrent other serious medical or surgical conditions affecting organ function that the investigator considers inappropriate for participation in this clinical trial; 13) Participation in other investigational drug clinical trials within 4 weeks; 14) Pregnant or lactating women, or patients with reproductive potential (men or women who have been post-menopausal for less than 1 year) who are unwilling to use adequate contraceptive measures; 15) Patients with a history of allergic or hypersensitivity reactions to any study drug components; 16) Patients deemed inappropriate for participation in this clinical trial by the investigator.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Dan Cao, MD, Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichua

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record