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A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer(NCT03262935)

Summary

To take part in this study, you must have HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. This study is comparing the safety and effects (good or bad) of a new targeted drug to a physician's choice standard treatment for advanced HER2+ breast cancer. The new targeted therapy is called SYD985. It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. The physician's standard of care drug combination will include two of the following: lapatinib (Tykerb®), capecitabine (Xeloda®), trastuzumab (Herceptin®), vinorelbine (Navelbine®), or eribulin (Halaven®).
This is a Phase III trial

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [DESTINY-Breast04] (NCT03734029)

Summary

To take part in this study you must have HER2-low advanced (some stage III) or metastatic (stage IV) breast cancer. This study is comparing the safety and effects (good or bad) of the new targeted therapy DS-8201a to the standard of care. HER2-low tumors are IHC/FISH 1+ or 2+. DS-8201a is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a topoisomerase I inhibitor directly to cancer cells.
This is a Phase III trial

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer (NCT03523572)

Summary

To take part in this study, you must have HER2 positive or low HER2 expression advanced (some stage III) or metastatic (stage IV) breast cancer that did not respond to standard therapies.

This study will test the safety and effects (good or bad) of an experimental drug called DS-8201 when it is given along with an immunotherapy to treat advanced breast cancer. DS-8201a (Trastuzumab deruxtecan) is a new type of HER2-targeted therapy. It is an antibody-drug conjugate (ADC), which means it uses an antibody to deliver a chemotherapy drug directly to the cancer cells. The immunotherapy being used in this study is the PD-1 inhibitor nivolumab (Opdivo®). By blocking PD-1, it allows your immune system to see and go after cancer cells. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] (NCT03529110)

Summary

To take part in this study, you must have HER2 positive, advanced (some stage III) or metastatic (stage IV) breast cancer and have already been treated with T-DM1 (Kadcyla®).

This study is comparing the effects (good or bad) of an experimental HER2 targeted therapy called DS-8201 to the standard of care in patients with advanced breast cancer who have already been treated with the HER2 targeted therapy Kadcyla. DS-8201 is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. The two standard of care options used in this study are the HER2 targeted therapy trastuzumab (Herceptin®) given with the chemotherapy drug capecitabine (Xeloda®) and the HER2-targeted therapy lapatinib (Tykerb®) given with Xeloda.

A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients With Advanced Solid Tumors (NCT03504488)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies.

This study is investigating the safety and effects (good or bad) of an experimental drug called CAB-ROR2-ADC (BA3021). CAB-ROR2-ADC is a type of drug called an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. The antibody in this drug targets ROR2 proteins. This study is also enrolling patients with other types of advanced cancer.

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T DM1 [DESTINY-Breast02] (NCT03523585)

Summary

To take part in this study, you must have HER2 positive, advanced (some stage III) or metastatic (stage IV) breast cancer and have already been treated with T-DM1 (Kadcyla®).

This study is comparing the effects (good or bad) of an experimental HER2 targeted therapy called DS-8201 to the standard of care in patients with advanced breast cancer who have already been treated with the HER2 targeted therapy Kadcyla. DS-8201 is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells. The two standard of care options used in this study are the HER2 targeted therapy trastuzumab (Herceptin®) given with the chemotherapy drug capecitabine (Xeloda®) and the HER2-targeted therapy lapatinib (Tykerb®) given with Xeloda.

A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With LIV-1-Positive Metastatic Breast Cancer (NCT01969643)

Summary

Antibody-drug conjugate (ADC) is a cancer therapy that combines an antibody that targets cancer cells with a drug that can kill cancer cells. Because the antibody only targets cancer cells, the drug does not kill normal cells, making it less likely to cause side effects. SGN-LIV1A is an ADC that targets LIV-1 (SLC39A6), a protein that is expressed by most breast cancer cells, and delivers a cancer drug called monomethyl auristatin E. This study will assess the safety, highest tolerable dose and anti-tumor activity of SGN-LIV1A in women with HER2-negative metastatic breast cancer. To be eligible, participants must have triple negative metastatic breast cancer or HER2-negative, hormone sensitive metastatic breast cancer that can no longer be treated with a hormone therapy.

Phase 1/2, Multicenter, Open-label, Multiple-Dose First-in-human Study of U3-1402, in Subjects With HER3 Positive Metastatic Breast Cancer (NCT02980341)

Summary

To take part in this study you must have advanced (stage III) or metastatic (stage IV) breast cancer that is HER2 negative and HER3 positive and have had 2-6 prior chemotherapy regimens, at least 2 of which were for advanced cancer, and at least 1 that included a taxane.

This study will evaluate the safety, effects (good or bad) and best dose of U3 1402. This drug is an investigational antibody-drug conjugate (ADC). It uses an antibody that targets HER3 on cancer cells to deliver a chemotherapy drug called MAAA-1181a directly to these cells.

ATOP TRIAL: Adjuvant Ado-Trastuzumab Emtansine (T-DM1) for Older Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (NCT03587740)

Summary

To take part in this study you must have HER2 positive stage I, II or III breast cancer.

This study is testing the safety and effectiveness of using T-DM1 (Kadcyla®) to treat early-stage HER2 positive breast cancer. T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody—the HER2-targeted therapy trastuzumab (Herceptin®)—to deliver the chemotherapy drug DM1 directly to the cancer cells. Kadclya is approved to treat HER2-positive metastatic breast cancer.

A Phase 1, Multicenter, Open-label, Multiple Dose-escalation Study of ARX788, Intravenously Administered as a Single Agent in Subjects With Advanced Cancers With HER2 Expression (NCT03255070)

Summary

To take part in this study you must have HER2 positive advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies and has already been treated with trastuzumab (Herceptin®).

This study is evaluating the safety, effects (good or bad) and best dose of ARX788. ARX788 is an antibody-drug conjugate (ADC). It uses an antibody that targets HER2 positive cancer cells to deliver a chemotherapy drug called amberstatin269 directly to these cells. This study is also enrolling patients with other types of advanced cancer.

An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer (NCT03243331)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic (stage IV) breast cancer.

This study is investigating the safety and effects (good or bad) of using two investigational drugs to treat metastatic triple negative breast cancer. The two drugs are gedatolisib and PTK7-ADC. Gedatolisib is a targeted therapy that works by blocking PI3K and mTOR kinase proteins, which play a role in the cellular pathways that help tumors grow. PTK7-ADC (PF-06647020) targets a protein called PTK7, which is often found on cancer cells. It is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a drug that can kill these cells.

A Phase 1B Dose Escalation Trial of Human Anti-4-1BB Agonistic Antibody PF-05082566 in Combination With Adotrastuzumab-Emtansine or Trastuzumab in Patients With HER2-Positive Advanced Breast Cancer (NCT03364348)

Summary

To take part in this study you must have HER2 positive advanced (some stage III) or metastatic (stage IV) breast cancer.

This study is investigating the safety and effects (good or bad) of using utomilumab (PF-05082566) with trastuzumab emtansine (Kadcyla®) or trastuzumab (Herceptin®). Utomilumab is an investigational immunotherapy that targets 4-1BB (CD-137), a molecule that stimulates the immune system. Herceptin is a HER2-targeted therapy approved to treat HER2 positive breast cancer. Kadcyla is an antibody-drug conjugate (ADC). It uses Herceptin to deliver the chemotherapy drug DM1 directly to the cancer cells. It is approved to treat HER2 positive metastatic breast cancer.

A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009) (NCT03149549)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer.

This study in investigating the safety and effects (good and bad) of a new immunotherapy for treating advanced breast cancer. CX-2009 A166 is an antibody-drug conjugate (ADC). It combines chemotherapy with targeted therapy, allowing it to deliver the chemotherapy directly to the cancer cells. This trial is also enrolling patients with other types of solid tumors.

Phase 1a/2a Dose Escalation Trial to Determine Safety, Tolerance, MTD, and Preliminary Antineoplastic Activity of AVID100, in Patients With Advanced or Metastatic Solid Tumors of Epithelial Origin (NCT03094169)

Summary

To take part in this study you must have advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options and tests positive for EGFR over-expression.

This study is to determine the safety and effects (good or bad) of using an experimental targeted therapy called AVID100. AVID100 is a targeted antibody-drug conjugate (ADC). It targets EGFR proteins to deliver a chemotherapy drug called maytansinoid mertansine (DM1). This study is also enrolling patients with other types of tumors that test EGFR positive.

A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06804103 IN PATIENTS WITH HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2) POSITIVE SOLID TUMORS (NCT03284723)

Summary

To take part in this study you must have locally advanced (stage III) or metastatic (stage IV) HER2+ breast cancer and have no standard treatment options available. This study is investigating the safety and effect (good or bad) of PF-06804103. This investigational therapy is an antibody drug conjugate (ADC). It uses a HER2-targeted agent to deliver the chemotherapy drug Auristatin-0101 directly to HER2+ cancer cells. This study is also enrolling patients with other types of HER2+ solid tumors.
This is a Phase I trial

A Phase I, Open-Label Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Escalating Doses of DHES0815A in Patients With HER2-Positive Breast Cancer (NCT03451162)

Summary

To take part in this study, you must have HER2-positive, advanced (some stage III) or metastatic (stage IV) breast cancer. You must also have already received a treatment that your cancer progressed on or did not respond to.

In this study, researchers will evaluate the safety, best dose, and effects (good and bad) of an experimental therapy called DHES0815A for treating HER2-positive metastatic breast cancer. DHES0815A is an antibody-drug conjugate (ADC). It combines chemotherapy with a HER2 targeted therapy, allowing it to deliver the chemotherapy directly to the cancer cells.

A Phase I Dose-Escalation Safety and Tolerability Study of Mirvetuximab Soravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC) (NCT02996825)

Summary

To take part in this study you must have stage IV metastatic breast cancer that is triple negative (ER-, PR- and HER2-) and folate receptor (FR) alpha-positive. You must not have had more than four lines of chemotherapy. This study is testing the safety and effects (good or bad) of a new drug called mirvetuximab soravtansine when it is given with the chemotherapy drug gemcitabine (Gemzar®). Mirvetuximab soravtansine is an antibody drug conjugate (ADC). It uses a drug that targets folate receptors on cancer cells to deliver the chemotherapy drug soravtansine directly to the tumor. Gemzar® is a chemotherapy drug approved to treat metastatic breast cancer. This study also is enrolling patients with other types of FR+ tumors.
This is a Phase I trial

A Phase I-II, FIH Study of A166 in Locally Advanced/Metastatic Solid Tumors Expressing Human Epidermal Growth Factor Receptor 2 (HER2) or Are HER2 Amplified That Did Not Respond or Stopped Responding to Approved Therapies (NCT03602079)

Summary

To take part in this study, you must have HER2 positive or low HER2 expression advanced (some stage III) or metastatic (stage IV) breast cancer that has not responded to standard therapies.

This study is evaluating the safety and effects (good and bad) of the experimental therapy A166 in women and men with advanced breast cancer. A166 is an antibody-drug conjugate (ADC). It combines chemotherapy with a HER2 targeted therapy, allowing it to deliver the chemotherapy directly to the cancer cells. This study is also enrolling patients with other types of advanced cancer.