SystImmune Inc.
The objective of this study is to evaluate the safety, tolerability, and efficacy of BL-M07D1 in patients with HER2 expressing advanced tumors.
BL-M07D1-ST-101 is a global, multi-center, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M07D1 in participants with HER2 expressing advanced malignant solid tumors. This study will be conducted in three parts (dose escalation, dose finding and dose expansion). Dosing will be conducted on Day 1 of a continuous 21-day treatment cycle. .
Inclusion Criteria: Participants must meet all the following inclusion criteria to be eligible for participation in this study: 1. Signed the informed consent form voluntarily and agreed to follow the program requirements. 2. Either sex 3. Age: ≥18 years 4. Life expectancy of ≥3 months 5. For Dose Escalation and Dose Finding: Documented locally advanced or metastatic HER2-expressing (IHC 1+ to 3+ and/or HER2 gene amplification or activating mutation \[see Table 17-5\] in tumor specimen by ISH or NGS) solid tumor(s) not amenable to curative surgery or radiation and has received at least 2 lin…
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