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1

NUV-868 Targeted Therapy for Advanced Triple Negative Breast Cancer

Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of NUV-868, an experimental targeted therapy, alone or with olaparib (Lynparza®) or enzalutamide (Xtandi®) targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received at least 1 line of chemotherapy for advanced or metastatic disease. If you have a BRCA mutation, you must have received treatment with talazoparib (Talzenna®) or olaparib (Lynparza®). View full eligibility criteria

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">NUV-868, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868 is an experimental targeted therapy called a BET inhibitor. Blocking BET may help slow or stop the growth of cancer cells.</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">Enzalutamide (Xtandi®) is a type of targeted therapy called an <span class="highlight">androgen</span> receptor (AR) inhibitor. It is approved to treat advanced prostate cancer.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2</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/NCT05252390' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nuvationbio.com/pipeline/' target='_blank'>Nuvation Bio: NUV-868 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><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612033.html' target='_blank'>MedlinePlus: Enzalutamide (Xtandi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>
1

NUV-868 Targeted Therapy for Advanced Triple Negative Breast Cancer

Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
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Nearest Location:
341 miles
Lawrence J. Ellison Institute for Transformative Medicine
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05252390

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Phase I-II

2

EP0062 Hormone Therapy for Advanced ER+, HER2- or HER2 Low, AR+ Breast Cancer

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of EP0062, an experimental hormone therapy.

Who is this for?: Postmenopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low, <span class="highlight">androgen</span> receptor positive (AR+) breast cancer with no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EP0062, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EP0062 is an experimental type of hormone therapy called a selective <span class="highlight">androgen</span> receptor modulator (SARM) that targets the <span class="highlight">androgen</span> receptor (AR).</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH-.</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/NCT05573126' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ellipses.life/portfolio/' target='_blank'>Ellipses Pharma: EP0062 Drug Information Page</a> </li></ul>
2

EP0062 Hormone Therapy for Advanced ER+, HER2- or HER2 Low, AR+ Breast Cancer

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer
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Nearest Location:
1482 miles
Texas Oncology Baylor University Medical Center
Dallas, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05573126

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Phase I-II

3

Evaluating PSMA Expression to Determine Response to Anti-Androgen Therapies for Metastatic HER2-, AR+ Breast Cancer

Evaluation of Prostate Specific Membrane Antigen (PSMA) in HER2-negative, <span class="highlight">Androgen</span> Receptor (AR)-Positive Metastatic Breast Cancer With 18F-DCFPyL PSMA-based PET/CT

Purpose: To evaluate prostate specific membrane antigen (PSMA) expression in breast cancer to determine people most likely to benefit from anti-androgen therapies.

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-), <span class="highlight">androgen</span> receptor positive (AR+) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scan with 18F-DCFPyL</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTC) test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Prostate specific membrane antigen (PSMA) expression may correlate with resistance to anti-androgen therapies, which has been documented in prostate cancer.</li> <li class="seamTextUnorderedListItem">Evaluating PSMA expression may be used to select people most likely to benefit from anti-androgen therapies, such as bicalutamide (Casodex®), in future clinical trials.</li> <li class="seamTextUnorderedListItem">18F-DCFPyL is a tracer that is used to visualize PSMA expression during imaging scans.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">Circulating tumor cells (CTCs) are breast cancer cells that leave the tumor and move through the bloodstream.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PSMA, AR</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/NCT04573231' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/news/psma-new-target-prostate-cancer-treatment' target='_blank'>Memorial Sloan Kettering Cancer Center: PSMA</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/tests/pet-ct-scan' target='_blank'>Cancer Research UK: PET/CT Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/ctc/#:~:text=A%20circulating%20tumor%20cell%20(CTC,test%20for%20metastatic%20breast%20cancer.' target='_blank'>Metastatic Trial Talk: Circulating Tumor Cell Testing</a> </li></ul>
3

Evaluating PSMA Expression to Determine Response to Anti-Androgen Therapies for Metastatic HER2-, AR+ Breast Cancer

Evaluation of Prostate Specific Membrane Antigen (PSMA) in HER2-negative, <span class="highlight">Androgen</span> Receptor (AR)-Positive Metastatic Breast Cancer With 18F-DCFPyL PSMA-based PET/CT
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Nearest Location:
1761 miles
University of Wisconsin School of Medicine and Public Health
Madison, WI

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04573231

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Phase II

4

Enzalutamide Alone or With Mifepristone for Advanced Triple Negative or ER Low, <span class="highlight">Androgen</span> Receptor Positive Breast Cancer

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of enzalutamide (Xtandi®), an experimental hormone therapy, alone or with mifepristone, an experimental hormone therapy, compared to standard of care chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2-) or ER low, <span class="highlight">androgen</span> receptor positive (AR+) breast cancer who have received 0-1 lines of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Mifepristone, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®) is an anti-androgen hormone therapy approved for people with prostate cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Mifepristone is an anti-progesterone hormone therapy. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), paclitaxel (Taxol®), capecitabine (Xeloda®), and eribulin (Halaven®) are standard of care chemotherapy medications used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">If you are in group 3, you may be able to switch to group 2 if your cancer progresses.</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/NCT06099769' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612033.html' target='_blank'>Medline Plus: Enzalutamide (Xtandi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
4

Enzalutamide Alone or With Mifepristone for Advanced Triple Negative or ER Low, <span class="highlight">Androgen</span> Receptor Positive Breast Cancer

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06099769

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Phase II

5

PET/MRI Scans with 18F-FDHT Tracer for Women with Advanced AR+ Breast Cancer

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer

Purpose: To study if PET/MRI scans with 18F-FDHT are an effective way of identifying AR+ breast cancer.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) <span class="highlight">androgen</span> receptor positive (AR+) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/MRI scan with 18F-FDHT</li> <li class="seamTextUnorderedListItem">PET/CT scan with 18F-FDG</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scans with 18F-FDG is a standard of care imaging scan.</li> <li class="seamTextUnorderedListItem">PET/MRI scans with 18F-FDHT is an experimental imaging scan. 18F-FDHT is an experimental tracer.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AR</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/NCT06145399' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancercenter.com/diagnosing-cancer/diagnostic-imaging/pet-ct-scan' target='_blank'>City of Hope: PET vs. CT vs. MRI Scan</a> </li></ul>
5

PET/MRI Scans with 18F-FDHT Tracer for Women with Advanced AR+ Breast Cancer

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer
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Nearest Location:
2567 miles
Memorial Sloan Kettering Cancer Center
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06145399

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Phase NA

6

Abemaciclib With Bicalutamide for <span class="highlight">Androgen</span> Receptor+, HER2- Advanced Breast Cancer

A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for <span class="highlight">Androgen</span> Receptor-positive, HER2-negative Metastatic Breast Cancer

Purpose: To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®) together with bicalutamide (Casodex®), an anti-androgen drug.

Who is this for?: Postmenopausal women with advanced (some stage III) or metastatic (stage IV) <span class="highlight">androgen</span> receptor positive (AR+) HER2 negative breast cancer. You must have received at least one line of therapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®), by mouth, twice daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate 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/NCT05095207' target='_blank'>ClinicalTrials.gov</a> </li></ul>
6

Abemaciclib With Bicalutamide for <span class="highlight">Androgen</span> Receptor+, HER2- Advanced Breast Cancer

A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for <span class="highlight">Androgen</span> Receptor-positive, HER2-negative Metastatic Breast Cancer
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Nearest Location:
2568 miles
Mount Sinai - West
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05095207

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Phase I-II

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