OncoMatch/Clinical Trials/NCT07892573
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
Is NCT07892573 recruiting? Yes, currently enrolling (Oct 2026). This NA trial studies multiple treatments including Becotatug Vedotin and Anti-PD-1 antibody for pancreatic cancer.
Treatment: Becotatug Vedotin · Anti-PD-1 antibody · S-1 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: EGFR expression (1+/2+/3+)
Performance status
ECOG 0–3(Limited self-care)
Demographics
Prior therapy
Must have received: systemic pharmacotherapy
must have received at least one prior line of standard systemic pharmacotherapy
Cannot have received: antibody-drug conjugate containing MMAE
Previous treatment with an antibody-drug conjugate containing MMAE as the cytotoxic payload
Cannot have received: S-1 (S-1)
previous use of S-1
Lab requirements
Blood counts
hemoglobin > 9 g/dL (no transfusion/erythropoietin within 14 days); ANC ≥ 1.5 x 10^9/L (no G-CSF within 14 days); platelets ≥ 80 x 10^9/L (no transfusion within 14 days)
Kidney function
serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)
Liver function
total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert syndrome); ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases)
Adequate organ and bone marrow function; screening laboratory tests must meet all of the following criteria: hemoglobin > 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07892573 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate containing MMAE, S-1 disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 85 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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