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New treatment option for Triple Negative Breast Cancer
Official title A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
ClinicalTrials.gov ID: NCT06908928
What this study is testing
What is bulumtatug fuvedotin?
bulumtatug fuvedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple negative breast cancer.
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
- The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have previously received treatment with an antibody-drug conjugates.
- Phase 1: an early, usually small safety 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
- Patient has measurable disease by RECIST v1.1
- Recurrent or metastatic triple-negative breast cancer patients as per current ASCO/CAP guidelines
- Patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload.
- Patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.
- Provision of archival tumor tissue or fresh tumor biopsy.
You likely can't join if
- Have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other MMAE based or nectin-4 targeted antibody-drug conjugates.
- Unstable CNS metastasis requiring treatment in the last 28 days.
- Acute infection requiring IV treatment in the last 14 days.
- Grade ≥2 peripheral neuropathy.
- Pregnant or breastfeeding women.
- Life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk
See the full eligibility criteria
- Patient has measurable disease by RECIST v1.1
- Recurrent or metastatic triple-negative breast cancer patients as per current ASCO/CAP guidelines
- Patient has received prior treatment with a taxane and an antibody-drug conjugate with a topoisomerase inhibitor payload.
- Patient has received no more than 3 prior lines of cytotoxic therapy in the locally advanced or metastatic setting.
- Provision of archival tumor tissue or fresh tumor biopsy.
- Capable of giving informed consent
- Male or female people aged ≥ 18 years.
- people must be willing to receive blood transfusions if medically indicated.
- ECOG 0-1
- Adequate hematologic and organ function
- Life expectancy of at least 3 months as assessed by the investigator
- Compliance with contraceptive requirement
- Have received any prior treatment with enfortumab vedotin, tisotumab vedotin or other MMAE based or nectin-4 targeted antibody-drug conjugates.
- Unstable CNS metastasis requiring treatment in the last 28 days.
- Acute infection requiring IV treatment in the last 14 days.
- Grade ≥2 peripheral neuropathy.
- Pregnant or breastfeeding women.
- Life-threatening illness or uncontrolled medical conditions that could compromise the subject's safety or put the study outcomes at risk
- Any systemic anticancer therapy in the last 28 days prior to first administration of study drug.
- Active HCV, HBV or HIV infection unless well controlled with anti-viral therapy.
- Active or chronic corneal disorder, keratitis, corneal ulcerations or Sjogren's syndrome.
- Have any ongoing acute inflammatory skin disease or chronic skin disease not well controlled.
- Have been diagnosed with another primary malignancy except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or people with another primary...
- Have significant, uncontrolled or active cardiovascular disease
- Have active or a history of pneumonitis or interstitial lung disease that requires corticosteroid treatment. Patients with radiation pneumonitis that does not require treatment is allowed.
- Have uncontrolled diabetes.
- Have received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.
- people known to be hypersensitive to bulumtatug fuvedotin or to any components of the formulation.
- History of drug abuse including narcotic and psychiatric drugs within 12 months prior to screening.
- Have received a live vaccine within 30 days of planned start of study therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- La Jolla, California, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Duarte, California, United States; La Jolla, California, United States; Aurora, Colorado, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; New York, New York, United States. 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.