A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This study is a single-arm, open, multicenter, non-randomized phase Ib/II clinical study evaluating the efficacy and safety of BL-M07D1 for injection in patients with HER2-expressing recurrent or metastatic gynecologic malignancies.

Eligibility criteria

Qualifiers

Sign the informed consent form voluntarily and follow the protocol requirements;

Female;

Age: ≥18 years old and ≤75 years old;

Expected survival time ≥3 months;

Disqualifiers

had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas; Oral fluorouracils; Palliative radiotherapy; Anti-tumor traditional Chinese medicine or Chinese patent medicine;

had received prior ADC drug therapy with camptothecin derivative (topoisomerase I inhibitor) as toxin;

had a history of serious cardiovascular and cerebrovascular diseases;

active autoimmune or inflammatory diseases;

Trial design

Treatments tested in this trial

  • BL-M07D1

Treatment groups

138 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator