A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors
What's involved?
<p class="seamTextPara">
You will be assigned to 1 of 3 groups:
</p>
<p class="seamTextPara">
<i class="seamTextEmphasis">Group 1</i>
</p>
<ul class="seamTextUnorderedList">
<li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li>
<li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®), by IV, every 3 weeks</li>
</ul>
<p class="seamTextPara">
<i class="seamTextEmphasis">Group 2</i>
</p>
<ul class="seamTextUnorderedList">
<li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li>
<li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-Dxd), by IV, every 3 weeks</li>
</ul>
<p class="seamTextPara">
<i class="seamTextEmphasis">Group 3</i>
</p>
<ul class="seamTextUnorderedList">
<li class="seamTextUnorderedListItem">ZN-A-1041, by mouth, daily</li>
<li class="seamTextUnorderedListItem">Pertuzumab/trastuzumab (PHESGO®), by injection, every 3 weeks</li></ul>
What's being studied?
<ul class="seamTextUnorderedList">
<li class="seamTextUnorderedListItem">ZN-A-1041 is an experimental anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li>
<li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®) and trastuzumab deruxtecan (T-Dxd, Enhertu®) are antibody drug conjugates (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 emtansine and trastuzumab deruxtecan target HER2 and deliver anti-cancer drugs.</li>
<li class="seamTextUnorderedListItem">Pertuzumab/trastuzumab (PHESGO®) is a combination of two anti-HER2 targeted therapies, pertuzumab (Perjeta®) and trastuzumab (Herceptin®). You may also receive the two drugs separately.</li>
<li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 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/NCT05593094' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.businesswire.com/news/home/20200907005109/en/Zion-Pharma-Announces-Initiation-of-Phase-1-Study' target='_blank'>Zion Pharma Press Release: ZN-A-1041</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab emtansine (T-DM1, Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (T-Dxd, Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/phesgo' target='_blank'>Breastcancer.org: Pertuzumab/trastuzumab (PHESGO®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-anti-her2-therapies' target='_blank'>Breastcancer.org: Anti-HER2 Targeted Therapy</a> </li></ul>