JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure

A Phase Ib/II Clinical Trial of JDB153 Combined With Serplulimab for the Treatment of Pancreatic Cancer Refractory to Standard Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractory Pancreatic Adenocarcinoma; Refractory Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Drug: JDB153; Drug: Serplulimab

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Dan Cao, MD; Phone Number: +8618980605963; Email: caodan@scu.edu.cn
• Study Contact Backup: Name: Hong Zhu, MD; Phone Number: +8615828320185

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
      • Principal Investigator: Dan Cao, MD
      • Contact: Dan Cao, MD; Phone Number: +8618980605963; Email: caodan@scu.edu.cn
      • Contact: Hong Zhu, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: West China Hospital
• 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, Sichuan University, Chengdu, Sichuan

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 9, 2025
• First Submitted That Met QC Criteria: September 9, 2025
• First Posted (Estimated): September 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Serplulimab; JDB153
• 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: JDB153-IIT-PDAC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to privacy protection requirements, regulatory restrictions in China, and limitations in the original informed consent process that did not include provisions for external data sharing.

Drug and device information, study documents

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