A Dose Randomization Study of Bulumtatug Fuvedotin in TNBC Patients Previously Treated With ADCs

March 16, 2026 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Hope Rugo
        • Contact:
          • Phone Number: 877-460-2954
      • La Jolla, California, United States, 92093
        • Recruiting
        • UCSD Moores Cancer Center
        • Principal Investigator:
          • Rebecca Shatsky
        • Contact:
          • Phone Number: 866-773-2703
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Anschutz Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • UChicago Medicine Comprehensive Cancer Center
        • Principal Investigator:
          • Rita Nanda
        • Contact:
          • Phone Number: 855-702-8222
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Nour Abuhadra
        • Contact:
          • Phone Number: 646-888-6885

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dose level 1 of BFv
Drug: bulumtatug fuvedotin
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
Drug: bulumtatug fuvedotin
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2
Experimental: Dose level 2 of BFv
Drug: bulumtatug fuvedotin
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 1
Drug: bulumtatug fuvedotin
given via intravenous infusion on day 1 and day 8 of every 21-day cycle at dose level 2

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Up to approximately 2 years
Objective Response Rate according to RECIST v1.1 by investigator assessment
Up to approximately 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: Up to approximately 2 years
The percentage of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as per RECIST v1.1.
Up to approximately 2 years
Clinical benefit rate
Time Frame: Up to approximately 2 years
The percentage of patients who achieve CR, PR, or SD for at least 6 months.
Up to approximately 2 years
Duration of response
Time Frame: Up to approximately 2 years
The time from first documented response (CR or PR) to disease progression or death, whichever occurs first.
Up to approximately 2 years
Progression-free survival
Time Frame: Up to approximately 2 years
The time from treatment initiation to disease progression or death from any cause.
Up to approximately 2 years
Overall survival
Time Frame: Up to approximately 2 years
The time from treatment initiation to death from any cause.
Up to approximately 2 years
Time to Maximum Concentration (Tmax)
Time Frame: Up to approximately 2 years
Time to reach the maximum observed concentration of bulumtatug fuvedotin, TAb, and MMAE in blood.
Up to approximately 2 years
Maximum Concentration (Cmax)
Time Frame: Up to approximately 2 years
Maximum observed blood concentration of bulumtatug fuvedotin, TAb, and MMAE.
Up to approximately 2 years
Half-life (t1/2)
Time Frame: Up to approximately 2 years
The time required for the blood concentration of bulumtatug fuvedotin, TAb, and MMAE to decrease by 50%.
Up to approximately 2 years
Area Under the Plasma Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
Time Frame: Up to approximately 2 years
The area under the plasma concentration-time curve from time zero to the last measurable concentration for bulumtatug fuvedotin, TAb, and MMAE.
Up to approximately 2 years
Incidence, rate and severity of treatment-emergent adverse events.
Time Frame: Up to approximately 2 years
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.
Up to approximately 2 years
Immunogenicity
Time Frame: Up to approximately 2 years
Incidence and rates of ADA and Nab.
Up to approximately 2 years
Immunogenicity
Time Frame: Up to approximately 2 years
Titre of ADA and Nab.
Up to approximately 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy parameters and biomarkers including but not limited to nectin-4 expression level.
Time Frame: Up to approximately 2 years
The proportion of nectin-4 positive and negative patients. The proportion of nectin-4 positive patients who experienced objective response. The proportion of nectin-4 negative patients who experienced objective response.
Up to approximately 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mabwell (Shanghai) Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9MW2821-2022-CP103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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