Phase I Study of BL-M07D1 Infusion in Adults With Advanced or Metastatic HER2-Positive or Low-Expression Breast Cancer and Other Solid Tumors

What this Trial Is About

Researchers are studying BL-M07D1, an intravenous drug, to evaluate its safety, tolerability, and preliminary effectiveness in patients with locally advanced or metastatic HER2-positive or low-expression breast cancer and other solid tumors. This phase I trial aims to identify the dose-limiting toxicity, maximum tolerated dose, and the recommended dose for future studies. The study includes patients who have failed or are not eligible for standard therapies. Participants receive BL-M07D1 through intravenous infusion every three weeks during the first treatment cycle. Those who show clinical benefit may continue receiving additional cycles until disease progression, intolerable side effects, or other reasons cause treatment to stop. The study proceeds through phase Ia to phase Ib to determine safe dosing and monitor the drugs pharmacokinetics and immunogenicity. During the trial, participants will undergo assessments including tumor tissue analysis, imaging to measure lesions, and health evaluations such as heart function and blood tests. Researchers will track side effects, immune response to the drug, and tumor response over approximately 24 months. The primary outcomes focus on safety and dose recommendations within 21 days after the first dose, while secondary outcomes include longer-term measures like disease control, response duration, and progression-free survival.

A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Low Expression Breast Cancer and Other Solid Tumors