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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMabwell (Shanghai) Bioscience Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • bulumtatug fuvedotin
  • bulumtatug fuvedotin

Treatment groups

52 Participants
are divided into 2 treatment groups