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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.

Current position:News > News > Insights
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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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