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

Signed the informed consent form voluntarily and agreed to follow the program requirements.

Either sex

Age: ≥18 years

Life expectancy of ≥3 months

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

Participants with history of severe heart disease, such as symptomatic congestive heart failure (CHF) ≥ Grade 2 (CTCAE 5.0), New York Heart Association (NYHA)

Participants with prolonged QT interval corrected Fridericia formula ([QTcF]>470 msec), complete left bundle branch block, Grade 3 atrioventricular block

Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease, and Hashimoto's thyroiditis, etc. Participants with skin diseases that do not require systemic treatment (such as vitiligo, psoriasis), well-controlled type 1 diabetes, or hypothyroidism are permitted. For autoimmune conditions that are active but stable and low grade on systemic therapy, discussion with the medical monitor is required prior to screening

Trial design

Treatments tested in this trial

  • BL-M07D1

Treatment groups

280 Participants
are divided into 3 treatment groups

Sponsors and collaborators