NIPH Clinical Trials Search

NCCH2412/MK015 Trial

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Small Bowel Adenocarcinoma
Date of first enrollment	16/10/2025
Target sample size	27
Countries of recruitment
Study type	Interventional
Intervention(s)	Enfortumab Vedotin (recombinant) was administered as an intravenous infusion at a dose of 1.25 mg/kg (body weight) over at least 30 minutes, once weekly for three consecutive weeks, followed by a one-week rest. This 4-week cycle was repeated as one course of treatment.

Outcome(s)

Primary Outcome	Objective response rate (centrally assessed)
Secondary Outcome	Response rate (investigator assessed), progression-free survival, overall survival, disease control rate, incidence of adverse events, dose intensity, relative dose intensity,duration of response, and time to response

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1)Histologically or cytologically confirmed small bowel adenocarcinoma (duodenum excluding the ampulla of Vater, jejunum, or ileum) 2)One of the following a. to c. a. Unresectable locally advanced small bowel adenocarcinoma in which R0 resection would require combined resection of invaded organs and is judged infeasible. b. UICC-TNM stage IV SBA with distant metastasis c. Postoperative recurrence of small bowel adenocarcinoma 3)No symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiation or surgical intervention 4)No pericardial effusion, pleural effusion, or ascites requiring treatment 5)At least 18 years of age at enrollment 6) Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 7) One or more measurable lesions on contrast-enhanced CT (chest, abdomen, and pelvis: slice-thickness 5 mm or less) within 14 days before the date of enrollment (the same day of the week is allowed for 14 days or less) 8) Patients have been previously treated with platinum combination therapy (FOLFOX or CapeOX therapy) for locally advanced or metastatic small bowel adenocarcinoma and discontinued due to disease progression, recurrence, or toxicities 9)If prior testing (e.g., MSI, MMR, or comprehensive genomic profiling) has identified alterations that qualify for tumor-agnostic approved therapies, the patient must be refractory, intolerant, or ineligible to such therapies. These tests are not mandatory; lack of testing does not preclude enrollment. 10)Archived samples of tumor tissue from either the primary lesion or metastatic sites have been identified as available at the date of enrollment. If archival samples of tumor tissue are not available, consent has been obtained to undergo an additional biopsy to obtain tumor tissue prior to commencement of study drug administration 11)Within 14 days before the date of enrollment, the patient has not received any anticancer drugs (e.g., chemotherapy, molecular targeted therapy, immunotherapy), other investigational drugs and radiotherapy (including palliative radiotherapy) 12)Not undergoing surgery with general anesthesia within 28 days before the date of enrollment 13)Laboratory tests performed within 14 days before the enrollment date meet the following a. to g. However, patients should not receive granulocyte colony-stimulating factor(G-CSF) or blood transfusion within 7 days before the day of blood collection. a. Neutrophil count >=1,500/mm3 b. Platelet count >=10x 10(4)/mm 3 c. Hemoglobin>=8.5 g/dL d. AST<=100 U/L (acceptable to 200 U/L if hepatic metastasis) e. ALT<=100 U/L (acceptable to 200 U/L if hepatic metastatic) f. Total bilirubin <= 1.5 mg/dL g. Creatinine<=1.5 mg/dL However, if creatinine exceeds 1.5 mg/dL, an estimated creatinine clearance (eCCr) using Cockcroft-Gault equation or creatinine clearance (CCr) from a 24-hour urine collection is confirmed to be 30 mL/min or higher, it is eligible 14)For women of childbearing potential, they agree to contraception and not donate eggs for at least 2 months after obtaining informed consent and the last dose of the study drug Patients who are breastfeeding agree not to breastfeed for at least 3 weeks after obtaining informed consent. Men agree to contraception and not to donate sperm for at least 1 month after obtaining informed consent 15)Written informed consent has been obtained from the patient for study participation
Exclude criteria	1)Patients with active overlapping cancers (but not a.-d.: a. completely resected cancer: basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder carcinoma; b. gastrointestinal carcinoma curatively resected with ESD or EMR; c. localized prostate cancer with curative intent and no evidence of progression; low-or very-low-risk (according to standard-guidelines) localized prostate cancer during supervised/deferred treatment with no curative intent; and d. other cancers that have not recurred for more than 3 years 2)Active infection requiring systemic therapy 3)Interstitial lung diseases diagnosed by imaging or clinical findings, with or without the need for steroidal treatment 4)Poorly controlled diabetes mellitus: HbA1c >=8%, or HbA1c 7%<=HbA1c<8% with otherwise unexplained hyperglycemic symptoms (polyuria and/or polydipsia) 5)Known hypersensitivity to any of the excipients (histidine, trehalose dihydrate, polysorbate 20, etc.) in Enfortumab Vedotin or Enfortumab Vedotin preparations. Alternatively, it is known to be hypersensitive to biological agents made in Chinese hamster ovary cells 6)Ongoing sensory or motor neuropathy greater than or equal to Grade 2 7)History of cerebrovascular disease (stroke or transient ischemic attack), unstable angina pectoris, myocardial infarction, cardiac symptoms corresponding to New York Heart Association Class III to IV (congestive heart failure, etc.) in the 6 months before the date of enrollment 8)Persistent clinically significant toxicities (beyond Grade 2, excluding alopecia) associated with prior therapy (e.g., systemic chemotherapy, radiotherapy, or surgical treatment) 9)Ongoig clinically significant skin disorders (Grade 2 or higher in CTCAE v5.0) regardless of the presence of toxicities associated with prior treatment 10)Receiving continuous systemic administration of steroids or other immunosuppressive drugs 11)Active keratitis or corneal ulcer has been identified However, superficial punctate keratitis can be included if the investigator or sub-investigator judges the disease to be adequately treated 12)HIV antibody, HBs antigen, or HCV-RNA is positive (but HCV-RNA is required only if HCV antibody is positive) 13)HBs antigen is negative, HBs antibody or HBc antibody is positive, and HBV-DNA assay is positive (not excluded if HBV-DNA is below the limit of detection) 14)Women who are or may be pregnant 15)Psychosis or psychiatric symptoms that interfere with daily activities are concomitant, and participation in the trial is considered difficult