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PHASE 1/2 STUDY OF LINVOSELTAMAB (ANTI-BCMA X ANTI-CD3BISPECIFIC ANTIBODY) IN PREVIOUSLY UNTREATED PATIENTSWITH SYMPTOMATIC MULTIPLE MYELOMA

Principal Investigator:

Rajshekhar 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...
R4018-ONC-1721: A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

Principal Investigator:

June Y. Hou, MD

Contact Number:

212-342-5162

NCT Number:

NCT03564340

Population:

Adult

Phase:

I/II

The main purpose of this study is to: • Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or in combination with cemiplimab to research subjects with ovarian cancer without too many side effects. • The study will also look at the levels of REGN4018 and/or cemiplimab in the body and measure how well your body can remove the study drug(s). This is called pharmacokinetics. • The study will also look at any signs that REGN4018 alone or with cemiplimab can treat cancer. Are you Eligible? (Inclusion Criteria) Do you have ovarian cancer? Are...
Randomized Study of ONC-392 plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who Progressed on Androgen Receptor (AR) Pathway Inhibition

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05682443

Population:

Adult

Phase:

I/II

The main purpose of the study is to determine whether the study drug, ONC-392, together with a standard of care drug PLUVICTO® (Lutetium Lu 177 Vipivotide Tetraxetan), are safe and well tolerated, and whether two drugs are effective in treating prostate cancer, in comparison with the standard of care PLUVICTO® alone. ONC-392 has not yet been approved by the Food and Drug Administration (FDA). PLUVICTO® is FDA approved but is not approved to be combined with ONC-392. Are you Eligible? (Inclusion Criteria) Male 18 years or older -Confirmed prostate adenocarcinoma -Have had previous...
An Open-Label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, inAdvanced Solid Tumor Malignancies with SMARCA4/BRG1 Alterations- J5M-OX-JOXA

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06561685

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of an investigational treatment called LY4050784 in subjects with solid tumors that have a particular genetic abnormality (called an alteration or mutation) of a gene called SMARCA4 and/or BRG1. LY4050784 is an investigational (or experimental) drug, taken by mouth that targets a gene called SMARCA2/BRM, and may treat certain cancers. Investigational means neither the FDA nor any other health or regulatory authority in other countries have approved LY4050784. This study will be the first time LY4050784 will be tested in humans. Are you Eligible...
A Phase 1a/1b Study of the pan-KRAS Inhibitor LY4066434 in Participants with KRAS Mutant SolidTumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06607185

Population:

Adult

Phase:

I

This research study is being done to test the safety of an investigational treatment called LY4066434 when given alone or with other cancer drugs. LY4066434 is an investigational (or experimental) drug, taken orally. It was designed for patients that have abnormalities (also known as DNA mutations) in the KRAS gene that can occur in some types of cancer. LY4066434 is not approved by the U.S. Food and Drug Administration. Are you Eligible? (Inclusion Criteria) Must be ≥18 years of age, 2. Must be able to swallow tablets. 3. Must be able to comply with outpatient treatment, laboratory...
A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Principal Investigator:

Hua-Jay J Cherng, MD

Contact Number:

212-342-5162

NCT Number:

NCT04970901

Population:

Adult

Phase:

I

This study will look at the safety, effectiveness (efficacy) and tolerability of an investigational drug called loncastuximab tesirine in combination with other anti-cancer drugs polatuzumab vedotin, glofitamab and mosunetuzumab for patients with relapsed or refractory B-cell Non- Hodgkin Lymphoma. Loncastuximab tesirine is an antibody drug conjugate (ADC), which is a type of medicine that combines an antibody (a protein that binds to specific substances in the body) with a chemotherapy drug that can kill cells. The antibody part of the study drug potentially helps direct the chemotherapy to...
A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034 (balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT03860272

Population:

Adult

Phase:

I

This research study mainly aims to test the safety and tolerability of AGEN1181 and balstilimab and to determine the most appropriate dose of the study drug AGEN1181 alone and in combination with balstilimab. AGEN1181 targets cells that are a part of the body’s immune system to block a protein called cytotoxic T- lymphocyte associated protein-4 (CTLA-4). Balstilimab can specially block a protein called programmed-death 1 (PD-1) and prevent communication between this protein and receptors on the tumor-cells. These receptors are known to affect the body’s defense mechanism to...
A Feasibility Study Examining the Use of Non-Invasive Focused Ultrasound (FUS) with oral Etoposide Administration in Children, Adolescents, and Young Adults with Progressive Diffuse Midline Glioma (DMG)

Principal Investigator:

James Hinkley Garvin Jr, MD

Contact Number:

212-342-5162

NCT Number:

NCT05762419

Population:

Pediatrics/Adult

Phase:

I

Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY® microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine whether there are any clinical benefits of the study treatment. Children with progressive diffuse midline gliomas (DMGs) have very poor outcomes and have very limited options. One of the main obstacles in the effectiveness of medical...
A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT04227847

Population:

Adult

Phase:

I

You are being asked to participate in this study because you have Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and we are testing the study drug’s, SEA-CD70, to find out what its side effects are and to see if the study drug is safe for people with these types of cancer. are testing to see if SEA- CD70 is safe for people, and its side effects. SEA-CD70 is a type of drug called an antibody. Antibodies are part of your immune system. Usually they help protect you from getting sick. The purpose of this study is to use study drug SEA-CD70, and while using another antibody...
A Phase 1 Open-label, Multicenter Study Evaluating theSafety and Efficacy of KITE-363 or KITE-753, AutologousAnti-CD19/CD20 CAR T-cell Therapies, in Subjects WithRelapsed and/or Refractory B-cell Lymphoma

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT04989803

Population:

Adult

Phase:

I

You have been invited to participate in this study because you have relapsed and/or refractory B-cell lymphoma and standard therapies available to treat your disease have limited effectiveness. The purpose of this study is to find out if the experimental products, KITE-363 and KITE-753, are safe and effective in treating your relapsed and/or refractory B-cell lymphoma. Participants will receive either KITE-363 or KITE-753 one time through into the vein (IV) infusion. The experimental treatment would involve removing some of your immune cells, genetically engineering those cells to identify...

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