Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSystImmune Inc.

About this trial

The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.

Eligibility criteria

Qualifiers

Age: ≥18 years

Has a life expectancy of ≥3 months

Cohort 1: Subjects with HER2 expression in endometrial cancers (EC)

Cohort 2: Subjects with HER2 expression in cervical cancers (CC)

Disqualifiers

Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration

Subjects with history of severe heart disease

Subjects with prolonged QT interval (QTc >470 msec), complete left bundle branch block, Grade 3 atrioventricular block

Active autoimmune diseases and inflammatory diseases

Trial design

Treatments tested in this trial

  • BL-M07D1

Treatment groups

280 Participants
are divided into 3 treatment groups

Sponsors and collaborators