A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether bulumtatug fuvedotin works for adults with triple-negative breast cancer that has come back or spread. It compares doses in people who have already received an antibody-drug conjugate (ADC), a drug that carries cancer-killing medicine to cancer cells.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older and have triple-negative breast cancer that has come back or spread.
- Your cancer can be measured using the study’s rules.
- You have received a taxane chemotherapy drug and an ADC carrying a drug called a topoisomerase inhibitor.
- You have had no more than 3 courses of cell-killing cancer treatment for cancer that has spread nearby or to other parts of the body.
- You can provide a stored tumor sample or have a new tumor sample taken.
- You are fully active or can do light work, and your blood counts and organs work well enough.
- The study doctor expects you to live at least 3 months, and you can give informed consent to join.
- You agree to follow birth control rules and receive blood transfusions if needed.
Who can't join
- You have received enfortumab vedotin, tisotumab vedotin, or another ADC that carries MMAE or targets nectin-4. You have had cancer treatment that acts throughout the body within 28 days before the first study dose.
- You have unstable cancer spread to the brain or spinal cord that needed treatment in the past 28 days, or moderate or worse nerve damage outside the brain and spinal cord.
- You had an infection needing treatment through a vein in the past 14 days; have active hepatitis B, hepatitis C, or HIV that is not well controlled with antiviral drugs; or received a live vaccine within 30 days before the planned study start.
- You have an active or long-term disorder of the eye’s clear front layer, including swelling or sores; Sjogren’s syndrome; or an ongoing sudden skin inflammation or poorly controlled long-term skin disease.
- You have serious, uncontrolled, or active heart or blood vessel disease; uncontrolled diabetes; or another life-threatening or uncontrolled illness that could make the study unsafe or affect results.
- You have current or past lung inflammation or lung tissue disease that requires steroid treatment. Lung inflammation from radiation is allowed if it needs no treatment.
- You have another cancer, unless it is adequately treated non-melanoma skin cancer or very early cervical cancer, fully treated prostate cancer that has not spread, or another cancer with no return after treatment and at least 3 years since diagnosis.
- You are pregnant or breastfeeding; are allergic to the study drug or its ingredients; took a strong CYP3A4 inhibitor, a medicine that changes how some drugs are broken down, within 14 days before the first dose; or have a history of drug abuse within 12 months before screening.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 subjects aged ≥ 18 years. * Subjects 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 Exclusion Criteria: * 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 subjects with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy. * 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. * Subjects 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.
Study sites (7)
CA
- City of Hope · Duarte, CA 91010 · Study contact · 877-460-2954Hope Rugo, M.D. · Principal investigatorMore trials in Duarte
- UCSD Moores Cancer Center · La Jolla, CA 92093 · Study contact · 866-773-2703Rebecca Shatsky, M.D. · Principal investigatorMore trials in La Jolla
CO
- Anschutz Medical Center · Aurora, CO 80045Tenzin Olsen · Study contact · TENZINDOLMA.OLSEN@CUANSCHUTZ.EDUVirginia Borges, M.D. · Principal investigatorMore trials in Aurora
IL
- UChicago Medicine Comprehensive Cancer Center · Chicago, IL 60637 · Study contact · 855-702-8222Rita Nanda, M.D. · Principal investigatorMore trials in Chicago
MA
- Massachusetts General Hospital · Boston, MA 02114More trials in Boston
NY
- Memorial Sloan Kettering Cancer Center · New York, NY 10021 · Study contact · 646-888-6885Nour Abuhadra, M.D. · Principal investigatorMore trials in New York
TN
- Sarah Cannon Research Institute (SCRI) · Nashville, TN 37203Erika Hamilton, M.D. · Principal investigatorMore trials in Nashville