Triple Negative Breast CancerPhase 1NCT06908928
A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs
A Phase 1 study testing bulumtatug fuvedotin in people with Triple Negative Breast Cancer, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- bulumtatug fuvedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 7 sitesUnited States
- Study dates
- 11 Aug 2025to May 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 6 recruiting
- Recruiting
Anschutz Medical Center
Aurora, Colorado, 80045
Tenzin Olsen, TENZINDOLMA.OLSEN@CUANSCHUTZ.EDU
Virginia Borges, M.D.
- Withdrawn
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
UChicago Medicine Comprehensive Cancer Center
Chicago, Illinois, 60637
855-702-8222
Rita Nanda, M.D.
- Recruiting
City of Hope
Duarte, California, 91010
877-460-2954
Hope Rugo, M.D.
- Recruiting
UCSD Moores Cancer Center
La Jolla, California, 92093
866-773-2703
Rebecca Shatsky, M.D.
- Recruiting
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, 37203
Erika Hamilton, M.D.
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
646-888-6885
Nour Abuhadra, M.D.
About this study
Official title: 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
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.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- bulumtatug fuvedotin
- Keywords
- 9MW2821, bulumtatug fuvedotin
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bulumtatug fuvedotinDrug
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
bulumtatug fuvedotinDrug
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 of BFv | Experimental | Not described Receives: Drug: bulumtatug fuvedotin |
| Dose level 2 of BFv | Experimental | Not described Receives: Drug: bulumtatug fuvedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective Response Rate according to RECIST v1.1 by investigator assessment
Measured: Up to approximately 2 years
Secondary outcomes (12)
Disease control rate
The percentage of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as per RECIST v1.1.
Measured: Up to approximately 2 years
Clinical benefit rate
The percentage of patients who achieve CR, PR, or SD for at least 6 months.
Measured: Up to approximately 2 years
Duration of response
The time from first documented response (CR or PR) to disease progression or death, whichever occurs first.
Measured: Up to approximately 2 years
Progression-free survival
The time from treatment initiation to disease progression or death from any cause.
Measured: Up to approximately 2 years
Overall survival
The time from treatment initiation to death from any cause.
Measured: Up to approximately 2 years
Time to Maximum Concentration (Tmax)
Time to reach the maximum observed concentration of bulumtatug fuvedotin, TAb, and MMAE in blood.
Measured: Up to approximately 2 years
Maximum Concentration (Cmax)
Maximum observed blood concentration of bulumtatug fuvedotin, TAb, and MMAE.
Measured: Up to approximately 2 years
Half-life (t1/2)
The time required for the blood concentration of bulumtatug fuvedotin, TAb, and MMAE to decrease by 50%.
Measured: Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
The area under the plasma concentration-time curve from time zero to the last measurable concentration for bulumtatug fuvedotin, TAb, and MMAE.
Measured: Up to approximately 2 years
Incidence, rate and severity of treatment-emergent adverse events.
Incidence, rate and severity of AE, SAE, TRAE and AESI. Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, urinalysis, vital signs, and 12-Lead ECG record. Safety will be reported as incidence and rate of treatment-emergent adverse events using NCI CTCAE v5.0 criteria.
Measured: Up to approximately 2 years
Immunogenicity
Incidence and rates of ADA and Nab.
Measured: Up to approximately 2 years
Immunogenicity
Titre of ADA and Nab.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start11 Aug 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908928
- Sponsor's protocol ID
- 9MW2821-2022-CP103
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No