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New treatment option for Advanced Small Bowel Adenocarcinoma
Official title Enfortumab Vedotin in Patients With Advanced Small Bowel Adenocarcinoma Refractory or Intolerant to Platinum-based Combination Therapy
ClinicalTrials.gov ID: NCT07347314
What this study is testing
What is Enfortumab vedotin?
Enfortumab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced small bowel adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Small bowel adenocarcinoma is a rare cancer with a poor prognosis. For patients with locally advanced or metastatic disease, the usual first treatment is chemotherapy with platinum-based combinations such as FOLFOX or CapeOX.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed small bowel adenocarcinoma (duodenum excluding the ampulla of Vater, jejunum, or ileum). If pathology was...
- One of the following:
- unresectable locally advanced small bowel adenocarcinoma in which R0 resection would require combined resection of invaded organs and is judged...
- UICC-TNM stage IV small bowel adenocarcinoma with distant metastasis
- postoperative recurrence of small bowel adenocarcinoma.
You likely can't join if
- Active second primary malignancy.
- Active infection requiring systemic therapy.
- Interstitial lung disease/pneumonitis, diagnosed by imaging or clinical findings, current or prior, irrespective of steroid use.
- Poorly controlled diabetes mellitus: HbA1c ≥8%, or HbA1c 7.0-\<8.0% with otherwise unexplained hyperglycemic symptoms (polyuria and/or polydipsia).
- Known hypersensitivity to enfortumab vedotin, its excipients (e.g., histidine, trehalose dihydrate, polysorbate 20).
- Ongoing grade ≥2 sensory or motor peripheral neuropathy.
See the full eligibility criteria
- Histologically or cytologically confirmed small bowel adenocarcinoma (duodenum excluding the ampulla of Vater, jejunum, or ileum). If pathology was performed at another institution, slides/blocks must be reviewed by a...
- One of the following:
- unresectable locally advanced small bowel adenocarcinoma in which R0 resection would require combined resection of invaded organs and is judged infeasible
- UICC-TNM stage IV small bowel adenocarcinoma with distant metastasis
- postoperative recurrence of small bowel adenocarcinoma.
- No symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiation or surgical intervention.
- No clinically significant pericardial effusion, pleural effusion, or ascites requiring treatment.
- Age ≥18 years at registration.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1.
- ≥1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, on contrast-enhanced CT (slice thickness ≤5 mm) obtained within 14 days before registration.
- Prior platinum-based chemotherapy for unresectable locally advanced or metastatic small bowel adenocarcinoma (FOLFOX or CapeOX) with documented progression, recurrence or treatment discontinuation due to toxicity.
- If prior testing (e.g., microsatellite instability, mismatch repair, or comprehensive genomic profiling) has identified alterations that qualify for tumor-agnostic approved therapies, the patient must be refractory...
- Archival tumor tissue is available; if unavailable, the patient agrees to a pre-treatment biopsy to obtain tumor tissue.
- No anticancer chemotherapy or radiotherapy within 14 days before registration.
- No surgery under general anesthesia within 28 days before registration.
- Screening laboratory tests within 14 days before registration meet all of the following conditions:
- absolute neutrophil count ≥1,500/mm³
- platelet count≥100,000/mm³
- hemoglobin ≥8.5 g/dL
- AST ≤100 U/L (≤200 U/L with liver metastases)
- ALT ≤100 U/L (≤200 U/L with liver metastases)
- total bilirubin ≤1.5 mg/dL
- serum creatinine ≤1.5 mg/dL
- Contraception: Women of childbearing potential agree to use effective contraception and to refrain from oocyte donation from consent through ≥2 months after last dose; breastfeeding patients agree to withhold...
- Written informed consent obtained from the patient.
- Active second primary malignancy.
- Active infection requiring systemic therapy.
- Interstitial lung disease/pneumonitis, diagnosed by imaging or clinical findings, current or prior, irrespective of steroid use.
- Poorly controlled diabetes mellitus: HbA1c ≥8%, or HbA1c 7.0-\<8.0% with otherwise unexplained hyperglycemic symptoms (polyuria and/or polydipsia).
- Known hypersensitivity to enfortumab vedotin, its excipients (e.g., histidine, trehalose dihydrate, polysorbate 20).
- Ongoing grade ≥2 sensory or motor peripheral neuropathy.
- Cerebrovascular event, unstable angina, myocardial infarction, or severe heart failure within 6 months before registration.
- Ongoing grade ≥2 unresolved clinically significant toxicities from prior therapy, excluding alopecia.
- Ongoing grade ≥2 dermatologic disorders regardless of prior-treatment causality.
- Ongoing use of chronic systemic corticosteroids or other immunosuppressants.
- Active keratitis or corneal ulcer.
- Positive for HIV antibodies, HBs antigen, or HCV RNA
- Negative for HBs antigen, positive for HBs or HBc antibodies, and positive HBV DNA quantification (patients are not excluded if HBV DNA is detected but below the limit of quantification).
- Pregnant or possibly pregnant women.
- Psychiatric illness or psychiatric symptoms that interfere with activities of daily living and, in the investigator's judgment, preclude study participation.
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Japan
- Osaka, Japan
- Tokyo, Japan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Japan; Osaka, Japan; Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.