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PhAse 1/2 StuDy of Modern ImmunotherApy in BCG-Unresponsive, BCG-RelaPsing, and High-Risk BCG-Naive Non-muscle Invasive UroThelial Carcinoma of the BLADDER – (ADAPT-BLADDER) HCRN GU16-243

Principal Investigator:

Christopher B Anderson, MD

Contact Number:

212-342-5162

NCT Number:

NCT03317158

Population:

Adult

Phase:

I/II

This study is for patients who have bladder cancer that has not invaded muscle tissue and who have been treated with one or more surgical resections and Bacillus Calmette-Guerin or BCG, which was directly given into the bladder before. The main purpose of this trial is to show that durvalumab is safe when given alone, in combination with BCG treatments, and in combination with radiation therapy for patients whose bladder cancer has now come back. The overall goal of this trial is to see if the risk of the bladder cancer coming back can be decreased with this treatment regimen. Are you...
Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05163041

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate whether the investigational drug, BT7480, will be a safe and effective anticancer therapy. This is the first time BT7480 will be given to humans. BT7480 is designed to recognize and attach itself to both the Nectin-4 protein found on the surface of some cancer cells and CD137, a protein found on the surface of some immune cells. BT7480 binds to both Nectin-4 and CD137 and may activate immune cells to fight the Nectin-4- expressing cancers. Are you Eligible? (Inclusion Criteria) Must be aged 18 years or older. Must have locally advanced or metastatic...
PHASE 1/2 FIH STUDY OF REGN5458 (ANTI-BCMA X ANTI-CD3BISPECIFIC ANTIBODY) IN PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT03761108

Population:

Adult

Phase:

I/II

This study will look at the safety of a drug (REGN5458) in patients with multiple myeloma. It will also try to find out what the best dose of REGN5458 is and look for any signs that REGN5458 can help treat your cancer. REGN5458 is investigational, which means it has not been approved by the US Food and Drug Administration (FDA) for any condition. Are you Eligible? (Inclusion Criteria) Are you at least 18 years old? Have you been diagnosed with Multiple Myeloma? Has your disease progressed?
PHASE 1/2 STUDY OF LINVOSELTAMAB (ANTI-BCMA X ANTI-CD3BISPECIFIC ANTIBODY) IN PREVIOUSLY UNTREATED PATIENTSWITH SYMPTOMATIC MULTIPLE MYELOMA

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05828511

Population:

Adult

Phase:

I/II

This study is looking at people who have recently been newly diagnosed with a type of cancer called multiple myeloma (NDMM). The purpose of this study is to learn about the safety, tolerability (how your body reacts to the study drug), and effectiveness (tumor shrinkage) of linvoseltamab (called “study drug”) in participants with NDMM as a first step in determining if the study drug has a role to play in the treatment of NDMM. This study consists of 2 phases. Your study doctor will tell you which phase of the study you will be participating in. Are you Eligible? (Inclusion...
Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients with Molecularly Selected Cancers (ATTACC)

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT04972110

Population:

Adult

Phase:

I/II

The study is being done to learn how safe and effective the study drug, RP- 3500, is when given with either niraparib or olaparib to treat advanced cancer. Niraparib and olaparib belong to a group of drugs called PARP inhibitors. These drugs are designed to block an enzyme called PARP which may stop cancer cells from growing. RP 3500 belongs to a class of drugs called ATR inhibitors that are design to stop cancer cells from growing. Are you Eligible? (Inclusion Criteria) Aged 18 years or older. Diagnosed with locally advanced or metastatic cancer. Have not received prior therapy with another...
A Phase 1 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector inSubjects with Severe Sickle Cell Disease

Principal Investigator:

Markus Y Mapara, MD

Contact Number:

212-342-5162

Phase:

I

The purpose of this study is to evaluate the safety and ability of the autologous stem cell transplant with gene modified stem cells to treat sickle cell disease. The goal is to determine if a sufficient amount of normal hemoglobin (without sickling) can be produced after the gene modified stem cells are returned to the body. This study may provide information on the usefulness of LentiGlobin® BB305 as a future treatment for sickle cell disease. Genes, which we inherit from our parents, are pieces of information which provide the blueprints for all the proteins that keep our cells and...
A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies

Principal Investigator:

June Y. Hou, MD

Contact Number:

212-342-5162

NCT Number:

NCT02922764

Population:

Adult

Phase:

I

The main purpose of this study is learn about the the safety and side effects of the study drug, RGX-104. RGX-104 is an experimental drug. This means that RGX-104 is not approved by the Food and Drug Administration (FDA). This is the first time RGX-104 will be given to humans. Are you Eligible? (Inclusion Criteria) Do you have a confirmed solid tumor? Have you had treatment for your disease before? Or is there not a standard treatment available for your disease? Does your cancer continue to grow? Can your cancer not be removed by surgery? Are you 18 years of age or older?
A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients with Localized Clear Cell Renal Cell Carcinoma (SPARC-1 Trial)

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT04028245

Population:

Adult

Phase:

I

The purpose of this study is to study two experimental drugs called canakinumab and spartalizumab produced by Novartis to see if: • It is safe and feasible to give canakinumab and spartalizumab prior to radical nephrectomy? • Canakinumab and spartalizumab can kill cancer cells and bring immune cells into the kidney cancer when hen given to human subjects prior to radical nephrectomy? You are being asked to participate in this study because you have localized kidney cancer and you are planned to have a radical nephrectomy. People who usually have this do not receive any additional...
A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants with Gastrointestinal Malignancies

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT04104672

Population:

Adult

Phase:

I

This study is being done to see if potential new drugs, AB680 and AB122, can be safely given in combination with chemotherapy to study patients with pancreatic cancer. The standard chemotherapy treatments that will be given in combination with AB680 and AB122 are nab-paclitaxel and gemcitabine. AB680 and AB122 are are not approved by the United States Food and Drug Administration (U.S. FDA). Are you Eligible? (Inclusion Criteria) Are you at least 18 years old? Do you have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma? Are you naïve to any prior treatment...
A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 inPatients with Mature B-Cell Malignancies

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT04277637

Population:

Adult

Phase:

I

The purpose of this study is to look at the safety and tolerability of an investigational anticancer drug currently known as BGB-11417. This study aims to determine the range of BGB-11417 doses that can safely be used, the safest dosing schedule to minimize side effects when first taking BGB-11417, what side effects may be experienced when taking this drug, how your body processes this drug, and if this drug is effective against your cancer. Are you Eligible? (Inclusion Criteria) Provision of signed and dated written informed consent prior to any study specific procedures, sampling, or...

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