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1

BL-M07D1 ADC for Advanced HER2 Positive, HER2 Low, and HER2 Expressing Breast Cancer

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of BL-M07D1, an experimental antibody drug conjugate (ADC).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), HER2 low, or HER2 amplified breast cancer who have received at least 2 lines of therapy. You are also eligible if circulating tumor cells (CTCs) are HER2 amplified. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BL-M07D1, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BL-M07D1 is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">BL-M07D1's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called trastuzumab.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06293898' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://systimmune.com/bl-m07d1' target='_blank'>SystImmune: BL-M07D1 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
1

BL-M07D1 ADC for Advanced HER2 Positive, HER2 Low, and HER2 Expressing Breast Cancer

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects With HER2 Expressing Advanced Malignant Solid Tumors
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Nearest Location:
1643 miles
SystImmune Recruiting Site
Houston, TX

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06293898

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Phase I

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