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1

CX-5461 for Advanced Breast Cancer with a BRCA2 or PALB2 Mutation

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation

Purpose: To determine the safety and best dose of CX-5461, an experimental targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have a BRCA2 or PALB2 germline (genetic) mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461, by IV, 2 times per month</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461 is an experimental targeted therapy. </li> <li class="seamTextUnorderedListItem">It targets cells with a Homologous Recombination Deficiency <span class="highlight">(HRD)</span> mutation. </li> <li class="seamTextUnorderedListItem">It works by slowing down the growth of cancer cells or causing cancer cells to die.</li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of advanced cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA2, PALB2</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/NCT04890613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/senhwa-biosciences-receives-us-fda-study-may-proceed-letter-to-treat-brca2-or-palb2-solid-tumors-with-cx-5461-301198347.html' target='_blank'>Senhwa Biosciences Press Release: CX-5461</a> </li></ul>
1

CX-5461 for Advanced Breast Cancer with a BRCA2 or PALB2 Mutation

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation
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Nearest Location:
341 miles
University of California, Los Angeles
Santa Monica, CA

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Visits:
2 visits per month

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ClinicalTrials.gov: NCT04890613

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Phase I

2

PARP Inhibitor Olaparib for Metastatic Breast Cancer That Tests Positive for a BRCA1/2 Tumor Mutation

A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency <span class="highlight">(HRD)</span> Positive Advanced Cancer

Purpose: To study the safety and anti-cancer activity of using the PARP inhibitor Olaparib (Lynparza®) in cancer with a BRCA1/2 tumor mutation.

Who is this for?: People with metastatic (stage IV) breast cancer that tests positive for a BRCA1 or BRCA2 tumor (not inherited) mutation who have already recieved an anthracycline and a taxane-based chemotherapy. You may not enroll in this trial if you have an inherited BRCA1/2 mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is olaparib (Lynparza®). It is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA1/2 mutation.</li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations can be inherited (also called germline) or in a tumor (also called somatic). </li> <li class="seamTextUnorderedListItem">This trial is only enrolling people with tumor BRCA1/2 mutations. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer that is BRCA1/2 tumor mutation positive.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1/2 tumor mutation</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/NCT03742895' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/results/metastatic-breast-cancer-results.html' target='_blank'>AstraZeneca Information Page: Lynparza® (Olaparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/parp-inhibitors-in-breast-cancer-treatment' target='_blank'>Breast Cancer Now: PARP Inhibitors in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mygenecounsel.com/my-tumor-carries-a-brca-mutation/' target='_blank'>My Gene Counsel: A BRCA Mutation Was Found in My Tumor. Does This Mean I’m a BRCA Carrier?</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/parp-inhibitors-cancer/' target='_blank'>Metastatic Trial Talk: Get the Latest News on PARP Inhibitors</a> </li></ul>
2

PARP Inhibitor Olaparib for Metastatic Breast Cancer That Tests Positive for a BRCA1/2 Tumor Mutation

A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency <span class="highlight">(HRD)</span> Positive Advanced Cancer
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Nearest Location:
675 miles
Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)
Seattle, WA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03742895

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Phase II

3

TNG348 Targeted Therapy Alone or With PARP Inhibitor for Advanced Breast Cancer with BRCA1/2 or <span class="highlight">HRD</span> Mutations

Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG348 Single Agent and in Combination With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or Other <span class="highlight">HRD+</span> Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of TNG348, an experimental USP1 inhibitor, alone or with olaparib (Lynparza®) PARP inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a BRCA1/2 or Homologous Recombination Deficiency <span class="highlight">(HRD)</span> mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TNG348</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TNG348</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TNG348 is an experimental targeted therapy called a USP1 inhibitor. Blocking USP1 may kill cancer cells with BRCA1/2 and Homologous Recombination Deficiency <span class="highlight">(HRD)</span> mutations.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, <span class="highlight">HRD</li></ul></span>

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/NCT06065059' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tangotx.com/programs/usp1/' target='_blank'>Tango Therapeutics: TNG348 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li></ul>
3

TNG348 Targeted Therapy Alone or With PARP Inhibitor for Advanced Breast Cancer with BRCA1/2 or <span class="highlight">HRD</span> Mutations

Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of TNG348 Single Agent and in Combination With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or Other <span class="highlight">HRD+</span> Solid Tumors
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Nearest Location:
948 miles
HealthONE
Denver, CO

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06065059

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Phase I-II

4

VIO-01 Targeted Therapy for Advanced HER2- Breast Cancer with HRR or <span class="highlight">HRD</span> Mutations

A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of VIO-01, an experimental targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have received 0-1 lines of therapy for advanced disease. You must have a BRCA1, BRCA2, PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, or other homologous recombination repair (HRR) or homologous recombination deficiency <span class="highlight">(HRD)</span> mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VIO-01, by IV, weekly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VIO-01 is an experimental targeted therapy called a DNA decoy drug. VIO-01 may prevent tumor cells from repairing tumor DNA which helps cancer grow.</li> <li class="seamTextUnorderedListItem">BRCA1, BRCA2, PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, are types of homologous recombination repair (HRR) or homologous recombination deficiency <span class="highlight">(HRD)</span> mutations.</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/NCT06257758' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://valeriotx.com/our-science/#pipeline' target='_blank'>Valerio Therapeutics: VIO-01 Drug Information Page</a> </li></ul>
4

VIO-01 Targeted Therapy for Advanced HER2- Breast Cancer with HRR or <span class="highlight">HRD</span> Mutations

A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors
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Nearest Location:
1482 miles
Next Oncology
San Antonio, TX

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Visits:
1 visit every week

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ClinicalTrials.gov: NCT06257758

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Phase I-II

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