Pancreatic CancerNCT07892573
Becotatug Vedotin Plus Anti-PD-1 and S-1 in Patients With EGFR-Positive Advanced Pancreatic Cancer Who Have Failed at Least One Line of Standard Therapy
A study testing Becotatug Vedotin, Anti-PD-1 antibody and S-1 in people with Pancreatic Cancer, run by Ningbo Medical Center Lihuili Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, single-center exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of a triplet regimen-becotatug vedotin combined with anti-PD-1 and S-1-in patients with EGFR-positive advanced pancreatic cancer who have failed at least one line of standard… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Becotatug Vedotin, Anti-PD-1 antibody and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2026to 1 Feb 2028
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understands the study procedures and content and voluntarily signs written informed consent.
- Age: 18 years or older.
- Histopathologically confirmed pancreatic cancer.
- The participant must have evidence of recurrence or metastasis, or have been assessed as not amenable to complete surgical resection, and must have received at least one prior line of standard systemic pharmacotherapy.
- EGFR positivity (1+/2+/3+) confirmed by immunohistochemistry.
- ECOG performance status of 0 to 3.
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- The patient must have at least one measurable target lesion according to RECIST v1.1.
- Adequate organ and bone marrow function; screening laboratory tests must meet all of the following criteria: hemoglobin greater than 9 g/dL without transfusion or erythropoietin within the preceding 14 days; absolute neutrophil count of 1.5 x 10^9/L or higher without the use of granulocyte colony-stimulating factor within the preceding 14 days; platelets of 80 x 10^9/L or higher without transfusion within the preceding 14 days; total bilirubin of 1.5 x upper limit of normal or less (up to 3 x upper limit of normal permitted for Gilbert syndrome), ALT and AST of 2.5 x upper limit of normal or less (5 x upper limit of normal permitted in the presence of liver metastases); serum creatinine of 1.5 x upper limit of normal or less, or creatinine clearance of 50 mL/min or higher according to the Cockcroft-Gault formula; adequate coagulation function, defined as an international normalized ratio or prothrombin time of 1.5 x upper limit of normal or less; and normal thyroid function, defined as thyroid-stimulating hormone within the normal range, although participants with an out-of-range baseline thyroid-stimulating hormone may be enrolled if total T3 (or FT3) and FT4 are within the normal range.
- Expected survival of more than 3 months.
- For women of childbearing potential, a negative urine or serum pregnancy test within 3 days before the first administration of study drug (Day 1 of Cycle 1). Women who are not of childbearing potential are defined as postmenopausal for at least 1 year, or surgically sterilized, or having undergone hysterectomy. If there is any risk of conception, all participants must use a contraceptive measure with an annual failure rate of less than 1% throughout the treatment period and for 120 days after the last dose of study drug.
- The participant is able and willing to comply with the visits, treatment plan, laboratory tests and other study-related procedures specified in the protocol.
Who cannot join
- Diagnosis of another malignant disease within 5 years before the first dose (excluding radically treated basal cell carcinoma and squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
- Previous treatment with an antibody-drug conjugate containing MMAE as the cytotoxic payload; previous use of S-1.
- Current participation in an interventional clinical study, or receipt of another investigational drug or treatment with an investigational device within 4 weeks before the first dose.
- Systemic treatment within 2 weeks before the first dose with a Chinese patent medicine having an antitumor indication, or with an immunomodulatory agent (including thymosin, interferon and interleukin), except for local administration for the control of pleural effusion.
- Active autoimmune disease requiring systemic treatment (for example disease-modifying agents, glucocorticoids or immunosuppressants) within 2 years before the first dose. Replacement therapy (for example thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment.
- Radiological evidence of tumor invasion or infiltration of a major blood vessel, or a bleeding tendency assessed by the investigator or the radiologist.
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- Major surgery (excluding surgery performed for the purpose of biopsy) within 4 weeks before the first dose of study drug, or planned major surgery during the study period.
- Serious non-healing wound, ulcer or fracture.
- Minor surgery (outpatient or inpatient procedure requiring local anesthesia, including placement of a central venous catheter) within 48 hours before the first dose of study drug.
- Current or recent (within 10 days before the first dose of study drug) continuous use for 10 days of aspirin (more than 325 mg/day) or of another non-steroidal anti-inflammatory drug known to inhibit platelet function.
- Current or recent (within 10 days before the first dose of study drug) treatment for 10 consecutive days with a full-dose oral or parenteral anticoagulant or thrombolytic agent. Note: prophylactic low-dose anticoagulation is permitted provided the international normalized ratio is 1.5 or less, in which case low-dose warfarin (1 mg/day or less), low-dose heparin (12,000 U/day or less) or low-dose aspirin (100 mg/day or less) may be used for prophylactic purposes.
- Hereditary bleeding tendency or coagulation disorder, or a history of thrombosis.
- Clinically uncontrollable pleural or peritoneal effusion (participants who do not require drainage, or in whom the effusion does not increase significantly after 3 days without drainage, may be enrolled).
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Known hypersensitivity to becotatug vedotin, anti-PD-1, or any active ingredient or excipient of these study drugs.
- Incomplete recovery from the toxicity and/or complications of any prior intervention before the start of treatment, i.e. toxicity worse than grade 1 or above baseline, excluding alopecia or fatigue.
- Known history of human immunodeficiency virus infection, i.e. positive for HIV 1/2 antibody.
- Untreated active hepatitis B, defined as HBsAg positive with detectable HBV-DNA copy number above the upper limit of normal of the local laboratory.
- Administration of a live vaccine within 30 days before the first dose (Day 1 of Cycle 1). Note: administration of an injectable inactivated seasonal influenza vaccine within 30 days before the first dose is permitted; intranasal live attenuated influenza vaccine is not permitted.
- Any medical history, disease evidence, treatment or abnormal laboratory value likely to interfere with the study results or to prevent full participation in the study, or any other condition judged by the investigator to carry an unacceptable risk, including severe or uncontrolled systemic disease such as unstable angina, congestive heart failure, chronic heart failure of New York Heart Association class 2 or higher; any arterial thrombosis, embolism or ischemia within 6 months before enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack; poorly controlled blood pressure (systolic blood pressure above 140 mmHg or diastolic blood pressure above 90 mmHg); active tuberculosis; active or uncontrolled infection requiring systemic treatment; clinically active diverticulitis, abdominal abscess or gastrointestinal obstruction; or a psychiatric disorder precluding cooperation with treatment.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315040
Yongfei Hua, 13095951515, huayongfei@nblhlyy.com
About this study
This is a prospective, single-arm, single-center exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of a triplet regimen-becotatug vedotin combined with anti-PD-1 and S-1-in patients with EGFR-positive advanced pancreatic cancer who have failed at least one line of standard systemic therapy. Pancreatic cancer is one of the most lethal malignancies, and patients who progress after first-line treatment have very limited effective options. The study plans to enroll 27 participants aged 18 years or older with histopathologically confirmed pancreatic cancer, evidence of recurrence or metastasis (or disease not amenable to complete surgical resection), EGFR positivity confirmed by immunohistochemistry, an ECOG performance status of 0 to 3, and at least one measurable target lesion. All participants will receive becotatug vedotin 2.0 mg/kg intravenously on Day 1 every three weeks, anti-PD-1 200 mg intravenously on Day 1 every three weeks, and oral S-1 40 to 60 mg twice daily on Days 1 to 14 followed by a 7-day rest, repeated every three weeks. Treatment will continue until disease progression, unacceptable toxicity, completion of 12 months of treatment, or other protocol-defined discontinuation criteria. Tumor response will be assessed by CT or MRI every 9 weeks according to RECIST v1.1, and safety will be assessed according to NCI-CTCAE version 5.0. The primary endpoint is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. The study duration is approximately 3 years, with participant enrollment planned from OCT. 2026 to OCT. 2027. All participants will receive active treatment; no placebo is included. This study addresses a major unmet medical need, as current second-line and later treatment options for advanced pancreatic cancer provide only limited benefit.
- Conditions
- Pancreatic Cancer
- Being tested
- Becotatug Vedotin, Anti-PD-1 antibody, S-1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug VedotinDrug
Becotatug vedotin 2.0 mg/kg administered intravenously on Day 1 of each 21-day cycle.
Anti-PD-1 antibodyDrug
Anti-PD-1 antibody 200 mg administered intravenously on Day 1 of each 21-day cycle.
S-1Drug
S-1 40 to 60 mg per dose according to body surface area, administered orally twice daily on Days 1 to 14 of each 21-day cycle, followed by a 7-day rest.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Becotatug Vedotin + Anti-PD-1 + S-1 | Experimental | Participants receive becotatug vedotin 2.0 mg/kg intravenously on Day 1 every three weeks, anti-PD-1 200 mg intravenously on Day 1 every three weeks, and oral S-1 40 to 60 mg twice daily on Days 1 to 14 followed by a 7-day rest, repeated every three weeks. Treatment continues until disease progression, unacceptable toxicity, completion of 12 months of treatment, or other protocol-defined discontinuation criteria. Receives: Drug: Becotatug Vedotin; Drug: Anti-PD-1 antibody; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of patients who achieve a complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator. ORR = (number of patients with CR or PR) / total number of patients × 100%. CR and PR are determined based on the best overall tumor response confirmed twice during the study.
Measured: Every 9 weeks (every three treatment cycles) from the start of treatment until disease progression, death, or end of study, up to approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start7 Oct 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ningbo Medical Center Lihuili Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892573
- Sponsor's protocol ID
- KY2026SL317-02
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becotatug Vedotin Plus Anti-PD-1 and S-1 in Patients With EGFR-Positive Advanced Pancreatic Cancer Who Have Failed at Least One Line of Standard Therapy
- ClinicalTrials.gov ID
- NCT07892573
- Acronym / sponsor ID
- KY2026SL317-02
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Ningbo Medical Center Lihuili HospitalOther government
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 23 Oct 2026 (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.
This is a prospective, single-arm, single-center exploratory clinical study. The purpose of this study is to evaluate the efficacy and safety of a triplet regimen-becotatug vedotin combined with anti-PD-1 and S-1-in patients with EGFR-positive advanced pancreatic cancer who have failed at least one line of standard systemic therapy. Pancreatic cancer is one of the most lethal malignancies, and patients who progress after first-line treatment have very limited effective options. The study plans to enroll 27 participants aged 18 years or older with histopathologically confirmed pancreatic cancer, evidence of recurrence or metastasis (or disease not amenable to complete surgical resection), EGFR positivity confirmed by immunohistochemistry, an ECOG performance status of 0 to 3, and at least one measurable target lesion. All participants will receive becotatug vedotin 2.0 mg/kg intravenously on Day 1 every three weeks, anti-PD-1 200 mg intravenously on Day 1 every three weeks, and oral S-1 40 to 60 mg twice daily on Days 1 to 14 followed by a 7-day rest, repeated every three weeks. Treatment will continue until disease progression, unacceptable toxicity, completion of 12 months of treatment, or other protocol-defined discontinuation criteria. Tumor response will be assessed by CT or MRI every 9 weeks according to RECIST v1.1, and safety will be assessed according to NCI-CTCAE version 5.0. The primary endpoint is objective response rate (ORR). Secondary endpoints include disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. The study duration is approximately 3 years, with participant enrollment planned from OCT. 2026 to OCT. 2027. All participants will receive active treatment; no placebo is included. This study addresses a major unmet medical need, as current second-line and later treatment options for advanced pancreatic cancer provide only limited benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Becotatug Vedotin + Anti-PD-1 + S-1 | Experimental | Drug: Becotatug Vedotin, Drug: Anti-PD-1 antibody, Drug: S-1Participants receive becotatug vedotin 2.0 mg/kg intravenously on Day 1 every three weeks, anti-PD-1 200 mg intravenously on Day 1 every three weeks, and oral S-1 40 to 60 mg twice daily on Days 1 to 14 followed by a 7-day rest, repeated every three weeks. Treatment continues until disease progression, unacceptable toxicity, completion of 12 months of treatment, or other protocol-defined discontinuation criteria. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Understands the study procedures and content and voluntarily signs written informed consent.
- Age: 18 years or older.
- Histopathologically confirmed pancreatic cancer.
- The participant must have evidence of recurrence or metastasis, or have been assessed as not amenable to complete surgical resection, and must have received at least one prior line of standard systemic pharmacotherapy.
- EGFR positivity (1+/2+/3+) confirmed by immunohistochemistry.
Key exclusion criteria (21 listed)
- Diagnosis of another malignant disease within 5 years before the first dose (excluding radically treated basal cell carcinoma and squamous cell carcinoma of the skin, and/or radically resected carcinoma in situ).
- Previous treatment with an antibody-drug conjugate containing MMAE as the cytotoxic payload; previous use of S-1.
- Current participation in an interventional clinical study, or receipt of another investigational drug or treatment with an investigational device within 4 weeks before the first dose.
- Systemic treatment within 2 weeks before the first dose with a Chinese patent medicine having an antitumor indication, or with an immunomodulatory agent (including thymosin, interferon and interleukin), except for local administration for the control of pleural effusion.
- Active autoimmune disease requiring systemic treatment (for example disease-modifying agents, glucocorticoids or immunosuppressants) within 2 years before the first dose. Replacement therapy (for example thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment.
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 |
|---|---|---|
| Becotatug VedotinBecotatug vedotin 2.0 mg/kg administered intravenously on Day 1 of each 21-day cycle. | Drug | Experimental: Becotatug Vedotin + Anti-PD-1 + S-1 |
| Anti-PD-1 antibodyAnti-PD-1 antibody 200 mg administered intravenously on Day 1 of each 21-day cycle. | Drug | Experimental: Becotatug Vedotin + Anti-PD-1 + S-1 |
| S-1S-1 40 to 60 mg per dose according to body surface area, administered orally twice daily on Days 1 to 14 of each 21-day cycle, followed by a 7-day rest. | Drug | Experimental: Becotatug Vedotin + Anti-PD-1 + S-1 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Every 9 weeks (every three treatment cycles) from the start of treatment until disease progression, death, or end of study, up to approximately 36 months.
Proportion of patients who achieve a complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the investigator. ORR = (number of patients with CR or PR) / total number of patients × 100%. CR and PR are determined based on the best overall tumor response confirmed twice during the study.
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 23 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Becotatug Vedotin, Anti-PD-1 antibody and S-1 in people with Pancreatic Cancer, run by Ningbo Medical Center Lihuili 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 11 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 23 Oct 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Every 9 weeks (every three treatment cycles) from the start of treatment until disease progression, death, or end of study, up to approximately 36 months.). 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 23 Oct 2026.