Refractory Pancreatic Ductal AdenocarcinomaPhase 1/2NCT07175389
JDB153 Combined With Serplulimab for Pancreatic Cancer After Standard Treatment Failure
A Phase 1/2 study testing JDB153 and Serplulimab in people with Refractory Pancreatic Ductal Adenocarcinoma and Refractory Pancreatic Adenocarcinoma, run by West China Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory Pancreatic Ductal Adenocarcinoma, Refractory Pancreatic Adenocarcinoma
- What is being tested?
- JDB153 and Serplulimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Huanji Xu, MD contact
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Dan Cao, MD, +8618980605963, caodan@scu.edu.cn
Huanji Xu, MD, xuhuanji1990@163.com
About this study
Official title: 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.
Read the 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.
- Being tested
- JDB153, Serplulimab
- Keywords
- Pancreatic Cancer, JDB153, Serplulimab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JDB153Drug
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.
SerplulimabDrug
Serplulimab is administered by intravenous infusion at a dose of 300 mg once every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| JDB153 combined with Serplulimab | Experimental | Not described Receives: Drug: JDB153; Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 2 years
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) and partial response (PR) according to RECIST v1.1 criteria
Measured: Approximately 2 years
Secondary outcomes (5)
Disease Control Rate (DCR)
Proportion of participants achieving complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 criteria
Measured: 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
Measured: Approximately 2 years
Time to Progression (TTP)
Time from study enrollment to disease progression according to RECIST v1.1 criteria
Measured: 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
Measured: Approximately 2 years
Overall Survival (OS)
Time from study enrollment to death from any cause
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Cao, West China Hospital
- Investigators
- Dan Cao, MD, Principal investigator, Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175389
- Sponsor's protocol ID
- JDB153-IIT-PDAC002
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial of JDB153 Combined With Serplulimab for the Treatment of Pancreatic Cancer Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT07175389
- Acronym / sponsor ID
- JDB153-IIT-PDAC002
- Keywords
- Pancreatic Cancer, JDB153, Serplulimab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JDB153 combined with Serplulimab | Experimental | Drug: JDB153, Drug: Serplulimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JDB153JDB153 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 | JDB153 combined with Serplulimab |
| SerplulimabSerplulimab is administered by intravenous infusion at a dose of 300 mg once every 3 weeks (Q3W). | Drug | JDB153 combined with Serplulimab |
Primary outcome
Incidence of Treatment-Related Adverse Events
Time frame: Approximately 2 years
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
Objective Response Rate (ORR)
Time frame: Approximately 2 years
Proportion of participants achieving complete response (CR) and partial response (PR) according to RECIST v1.1 criteria
5 secondary outcomes
Disease Control Rate (DCR)
Time frame: Approximately 2 years
Duration of Response (DoR)
Time frame: Approximately 2 years
Time to Progression (TTP)
Time frame: Approximately 2 years
Progression-Free Survival (PFS)
Time frame: Approximately 2 years
Overall Survival (OS)
Time frame: Approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huanji Xu, MD contact
Dan Cao, MD principal investigator
Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JDB153 and Serplulimab in people with Refractory Pancreatic Ductal Adenocarcinoma and Refractory Pancreatic Adenocarcinoma, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Cao, MD (+8618980605963, caodan@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Related Adverse Events (time frame: Approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.