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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • BL-M07D1

    Drug

    Drug: BL-M07D1 The study includes 3 parts: Part 1 Dose escalation. Part 2 Dose Finding non-randomized and Part 3 Dose expansion randomized. BL-M07D1 will be administered on Day 1 by intravenous infusion every 3 weeks. Other Names: BL-M07D1

Treatment groups

280 Participants
are divided into 3 treatment groups
Group A: Experimental: Dose EscalationExperimental treatment 1 intervention
Group B: Experimental: Dose FindingExperimental treatment 1 intervention
Group C: Experimental: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Summary of safety

The number of patients with dose-limiting toxicities, serious adverse events, treatment-emergent adverse events, physical exam findings, vital signs, laboratory tests, ECG parameters and echocardiograph

Time frame
Though study completion, an average of 24 months
2

To determine the maximum tolerated dose (MTD) if reached or maximum administered dose (MAD) and two or more recommended doses for dose expansion (RDEs) of BL-M07D1

Determine the highest BL-M07D1 dose level at which subjects do not experience a DLT during the DLT evaluation period and highest BL-M07D1 dose administered in the event and MTD cannot be defined.

Time frame
21 Days

Secondary outcomes

Other outcomes

Sponsors and contacts

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