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1

TransCon IL-2 β/γ Immunotherapy with Trastuzumab or Trastuzumab Emtansine (T-DM1) for Metastatic 3rd Line or Later HER2+ Breast Cancer

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

Purpose: To study the safety, best dose, and effects (good and bad) of TransCon IL-2 β/γ, an experimental immunotherapy, alone or with other anti-cancer therapies.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received at least 2 lines of therapy for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TransCon IL-2 β/γ, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) or Trastuzumab emtansine (T-DM1, Kadcyla®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TransCon IL-2 β/γ is an experimental immunotherapy that includes interleukin-2 (IL-2) and may work better than IL-2 alone.</li> <li class="seamTextUnorderedListItem">IL-2 activates immune cells to kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®) is an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An 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">T-DM1's antibody targets HER2 and delivers an anti-cancer drug called emtansine.</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/NCT05081609' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascendispharma.com/pipeline/oncology/' target='_blank'>Ascendis Pharma: TransCon Drug Information Page</a> </li></ul>
1

TransCon IL-2 β/γ Immunotherapy with Trastuzumab or Trastuzumab Emtansine (T-DM1) for Metastatic 3rd Line or Later HER2+ Breast Cancer

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies
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Nearest Location:
340 miles
Ascendis Pharma Investigational Site
Los Angeles, CA

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Visits:
At least 1 visit every 3 weeks

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ClinicalTrials.gov: NCT05081609

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Phase I-II

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