The FDA has granted clearance for the investigational new drug (IND) application for BL-M17D1, an antibody-drug conjugate (ADC), for the potential treatment of patients with advanced or metastatic solid tumors. This clearance paves the way for a phase 1 trial in the United States to assess the drug's safety, tolerability, pharmacokinetics (PK), and preliminary efficacy.
The phase 1 trial, titled BL‑M17D1-ST-101, will enroll patients with advanced or metastatic solid tumors. SystImmune, the developer of BL-M17D1, aims to bring transformative clinical benefits to patients through this novel therapy.
BL-M17D1: A Novel ADC
BL-M17D1 incorporates SystImmune's next-generation linker and payload technology. According to Jie D'Elia, chief executive officer of SystImmune, the initiation of clinical development for BL-M17D1 demonstrates the company's ability to innovate in the ADC space and bring potentially best-in-class products to patients.
Ongoing Trial in China
Currently, a phase 1 trial (NCT06503783) is ongoing in China, evaluating BL-M17D1 in patients with locally advanced or metastatic HER2-positive or HER2-negative breast cancer and other solid tumors. This open-label, multicenter, dose-escalation and expansion-enrollment study is nonrandomized.
In the Chinese trial, participants receive BL-M17D1 via intravenous infusion every three weeks. Treatment continues as long as patients derive clinical benefit, but may be discontinued due to disease progression or intolerable toxicity. Eligible patients are aged 18 to 75, have an ECOG performance status of 0 or 1, and have at least one measurable extracranial lesion. They must also provide archival or fresh tumor tissue samples and have adequate cardiac function. Prior toxicities from antineoplastic therapy must have resolved to grade 1 or less, as defined by NCI-CTCAE v5.0.
The primary endpoints for phase 1a of the Chinese study are to assess dose-limiting toxicities and determine the maximum tolerated dose. For phase 1b, investigators aim to define the recommended phase 2 dose of BL-M17D1. Secondary endpoints include treatment-emergent adverse effects and pharmacokinetic parameters. In phase 1b, secondary endpoints also include objective response rate, disease control rate, and duration of response.
