Bulumtatug Fuvedotin for Breast Cancer

Recruiting at 4 trial locations

Overseen By Wenhui Zhang, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

Must not be taking: Strong CYP3A4 inhibitors

Disqualifiers: Unstable CNS metastasis, Uncontrolled diabetes, Active HCV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 2 years

52 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called bulumtatug fuvedotin (an experimental drug) to determine its effectiveness for people with triple-negative breast cancer. This type of cancer does not respond to some common hormone therapies and tends to be more aggressive. The trial targets patients who have already received certain other treatments but still need help managing their cancer. Participants will receive one of two different doses of the treatment to identify which works best. For those with triple-negative breast cancer that has returned or spread after treatment, this trial might be suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires that you have not received any systemic anticancer therapy in the last 28 days before starting the study drug. Additionally, you should not have taken any strong CYP3A4 inhibitors within 14 days prior to the first dose. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that bulumtatug fuvedotin is likely to be safe for humans?

Research has shown that bulumtatug fuvedotin is generally well-tolerated by patients with various solid tumors, including breast cancer. Early trials showed promising results for this treatment. Although specific side effects have not been detailed, its successful use in other cancers suggests it might be safe for further testing in breast cancer. However, this is a Phase 1 trial, so researchers are still learning about its safety and the correct dosage. Participants should understand that while early results are encouraging, the trial's main goal is to determine the treatment's safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for breast cancer, which often include chemotherapy, hormone therapy, and targeted therapies like trastuzumab, Bulumtatug Fuvedotin stands out due to its novel mechanism of action. This treatment is an antibody-drug conjugate (ADC) that combines a monoclonal antibody with a potent cancer-killing agent. It specifically targets cancer cells, delivering the drug directly to the tumor while sparing healthy cells, which could potentially reduce side effects. Researchers are excited about Bulumtatug Fuvedotin because it offers a more precise approach to attacking cancer, potentially leading to better outcomes and fewer adverse reactions compared to traditional therapies.

What evidence suggests that bulumtatug fuvedotin might be an effective treatment for triple-negative breast cancer?

Research has shown that bulumtatug fuvedotin may help treat various types of cancer. In earlier studies, 50% of patients with triple-negative breast cancer (TNBC) experienced tumor shrinkage or disappearance after treatment, known as the objective response rate (ORR). Although these results are preliminary, they suggest that bulumtatug fuvedotin could be effective for TNBC. Further research is needed to confirm these findings, but the initial results are promising. Participants in this trial will receive different dose levels of bulumtatug fuvedotin to further evaluate its effectiveness and safety. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for patients with triple-negative breast cancer who have measurable disease and have been treated before with specific drugs, including a taxane and an antibody-drug conjugate. They should not have had more than three prior chemotherapy treatments in advanced stages, be able to consent, accept blood transfusions if needed, and be relatively active (ECOG 0-1) with good organ function.

Inclusion Criteria

* Patient has measurable disease by RECIST v1.1

My breast cancer is triple-negative and has come back or spread.

I have been treated with a taxane and a specific targeted therapy before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bulumtatug fuvedotin to assess its effectiveness in treating triple-negative breast cancer

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bulumtatug Fuvedotin

Trial Overview The study tests bulumtatug fuvedotin's effectiveness on those who've previously received antibody-drug conjugates. It aims to determine the right dose of this drug for patients with recurrent or metastatic triple-negative breast cancer.

How Is the Trial Designed?

Group I: Dose level 2 of BFv Experimental Treatment 1 Intervention

Group II: Dose level 1 of BFv Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mabwell (Shanghai) Bioscience Co., Ltd.

Lead Sponsor

Trials

42

Recruited

7,400+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0923753425001693

Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation ... Among 221 patients assessable for efficacy in 1.25 mg/kg group, objective response rates were 54.1%, 32.1%, 14.0% and 50% in urothelial cancer, cervical cancer, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06908928

NCT06908928 | A Dose Randomization Study of ... The goal of this clinical trial is to investigate if treatment with bulumtatug fuvedotin is effective in triple-negative breast cancer patients who have ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)00169-3/abstract

Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation ... Bulumtatug fuvedotin monotherapy demonstrated an ORR of 54.1%, 32.1%, 14.0% and 50% in advanced UC, CC, EC and TNBC, respectively. •. Bulumtatug ...

4. mabwell.com mabwell.com/en/news_info/id-184.html

Mabwell Announces First Patient Dosed in the US Clinical ... The multicenter clinical study (NCT06908928) aims to evaluate the efficacy and safety of BFv in TNBC patients previously treated with a taxane ...

5. prnewswire.com prnewswire.com/news-releases/mabwell-announces-first-patient-dosed-in-the-us-clinical-study-of-bulumtatug-fuvedotin-in-tnbc-patients-previously-treated-with-adcs-302527599.html

Mabwell Announces First Patient Dosed in the US Clinical ... The multicenter clinical study (NCT06908928) aims to evaluate the efficacy and safety of BFv in TNBC patients previously treated with a taxane ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40288679/

a first-in-human, open label, multicenter, phase Ⅰ/Ⅱ study Among 226 patients evaluable for efficacy, objective response rates were 54.1%, 32.1%, 14.0% and 50% in urothelial cancer, cervical cancer, ...