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HER2: FDA Approves Application for Phase I Clinical Trial of Paragon HER2 ADC for Solid Tumours
吉满生物
2024-11-08
On 8 Nov., SystImmune, Inc. received notification from the US FDA that its Phase I clinical trial application for BL-M17D1 (ADC) for the treatment of patients with advanced solid tumours has been approved by the FDA.

A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumorsimage.png

This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in patients with locally advanced or metastatic HER2 positive/negative breast cancer and other solid tumors.


At present, including the new FDA licence for BL-M17D1, the Company has a total of six projects that have been licensed by the FDA to conduct clinical research, and the other five are: BL-B01D1, BL-M07D1, SI-B001, BL-M05D1, BL-M11D1 clinical trials in the United States.

Learn more about our HER2 catalog.

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HER2: FDA Approves Application for Phase I Clinical Trial of Paragon HER2 ADC for Solid Tumours
吉满生物
2024-11-08
On 8 Nov., SystImmune, Inc. received notification from the US FDA that its Phase I clinical trial application for BL-M17D1 (ADC) for the treatment of patients with advanced solid tumours has been approved by the FDA.

A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumorsimage.png

This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in patients with locally advanced or metastatic HER2 positive/negative breast cancer and other solid tumors.


At present, including the new FDA licence for BL-M17D1, the Company has a total of six projects that have been licensed by the FDA to conduct clinical research, and the other five are: BL-B01D1, BL-M07D1, SI-B001, BL-M05D1, BL-M11D1 clinical trials in the United States.

Learn more about our HER2 catalog.

Contact Information
If you have any more questions, please fill in the relevant information and we will reply to you as soon as possible to provide assistance!
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