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1

GI-102 Bispecific Antibody Alone or With Immunotherapy for Advanced Breast Cancer

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patient...(KEYNOTE-G08)

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of GI-102, an experimental bispecific antibody, alone or with other anti-cancer drugs.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 5 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV or injection, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 1-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102 is an experimental immunotherapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two different targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd) is 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">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">The chemotherapies being used in this study are doxorubicin (Doxil®), paclitaxel (Taxol®), and eribulin (Halaven®).</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®) is a targeted therapy called a VEGF inhibitor. Blocking VEGF may slow or stop cancer cells from growing.</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/NCT05824975' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li></ul>
1

GI-102 Bispecific Antibody Alone or With Immunotherapy for Advanced Breast Cancer

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patient...(KEYNOTE-G08)
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Nearest Location:
660 miles
Mayo Clinic in Arizona
Scottsdale, AZ

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Visits:
At least 1 visit every 3 weeks

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ClinicalTrials.gov: NCT05824975

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Phase I-II

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