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A Phase 1/2, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of the Safety, Tolerability, Pharmacokinetic, and Antitumor Activity of E-602 as a Single Agent and in Combination with Cemiplimab in Patients with Advanced Cancers

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05259696

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of the study drug, E-602, at different dose levels both alone (monotherapy) and in combination with pembrolizumab (also known as Keytruda®).Pembrolizumab is FDA-approved for the treatment of some cancers, but not all of the cancers in this study. E-602 has not been approved by the United States Food and Drug Administration (FDA). This study is the first time that E-602 will be administered to participants. The study will also inform on what effects, both good and bad, E-602 alone and in combination with pembrolizumab have on participants...
A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients with Active Epidermal Growth Factor Receptor Mutation Locally Advanced or

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05519293

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety (the side effects) of H002, the study drug, and to determine the best dose of the drug to be given to patients. Another purpose is to find out the amount of study drug that is in your blood and how fast your body absorbs, metabolizes and eliminates the study drug from your body. This is the first study where H002 is being given to humans and it is not approved by the U.S. Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Must have life expectancy 3 months or more - Cannot have or major...
A First-In-Human, Open-Label, Multicenter Study of VOR33 in Patients with Acute Myeloid Leukemia who are at High-Risk for Leukemia Relapse following Hematopoietic Cell Transplantation

Principal Investigator:

Markus Y Mapara, MD

Contact Number:

212-342-5162

NCT Number:

NCT04849910

Population:

Adult

Phase:

I/II

You are being asked to take part in this study because you have acute myeloid leukemia (AML). Vor Biopharma, is a company that is testing a possible new treatment for AML. This possible new treatment, is VOR33. In this study, your blood-forming stem cells will be genetically modified to become VOR33. VOR33 has not been approved by the Food and Drug Administration (FDA). This is a first time VOR33 is being studied in humans. The sponsor of this study is looking to find out if VOR33 is safe. Are you Eligible? (Inclusion Criteria) Must be between 18 to 70 years old - Have a confirmed diagnosis...
A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men with Biochemical Recurrence after Definitive Local Therapy for Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05617040

Population:

Adult

Phase:

I/II

The purpose of this study is to determine how safe the study drug, VTP-850, is in people with prostate cancer who have had initial treatment but their prostate-specific antigen (PSA) levels have started to rise again. This study also aims to find the appropriate dose regimen of VTP-850 that can be given safely to people with prostate cancer. In addition, we want to see if VTP-850 brings about an immune response and if it has an effect on prostate cancer. VTP-850 is considered immunotherapeutic investigative drug, which means that it is meant to work by stimulating a person’s immune...
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF ORAL MRT-2359 IN PATIENTS WITH MYC-DRIVEN AND OTHER SELECTED SOLID TUMORS INCLUDING LUNG CANCER AND DIFFUSE LARGE B-CELL LYMPHOMA

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05546268

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety and confirm the best dose in humans for an investigational drug called MRT-2359 in subjects with solid tumors and diffuse large B-cell lymphoma. “Investigational” means the study drug has not been approved for the treatment of participants with cancer by the Food and Drug Administration (“FDA”) or any other health/regulatory authority anywhere in the world.MRT-2359 is called a molecular glue degrader or MGD. This MGD can selectively stick to a protein called G1 To S Phase Transition 1 (GSPT1) and cause GSPT1 to...
A PHASE 1/2 STUDY OF REGN5678 (ANTI-PSMAXCD28) WITH OR WITHOUT CEMIPLIMAB (ANTI-PD-1) IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AND OTHER TUMORS ASSOCIATED WITH PSMA EXPRESSION

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT03972657

Population:

Adult

Phase:

I/II

The purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness of REGN5678 which will be given alone first and then be given in combination with cemiplimab. Neither REGN5678 nor Cemiplimab is FDA approved to treat your type of cancer. Cemiplimab is approved by the FDA for the treatment of certain types of metastatic cutaneous squamous cell carcinoma (CSCC) (one of the main types of skin cancer ) or locally advanced CSCC (who are not candidates for curative surgery or curative radiation). REGN5678 has not yet been studied in people. Are...
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT04623541

Population:

Adult

Phase:

I/II

The purpose of this study is to investigate the safety and tolerability of the study drug, epcoritamab, as a treatment for Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome. This means the study will look into the potential side effects of epcoritamab and how well it works against your disease. This study will also measure epcoritamab levels in your blood and how long epcoritamab stays in your body. Are you Eligible? (Inclusion Criteria) • Must be at least 18 years of age • Women can not be pregnant • Male and Women of child bearing potential must agree 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/II

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 First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased DonorBone Marrow Transplantation for Patients with Hematologic Malignancies (PRESERVE I)

Principal Investigator:

Markus Y Mapara, MD

Contact Number:

212-342-5162

NCT Number:

NCT05589896

Population:

Adult

Phase:

I/II

The purpose of the study is to learn if a transplant using bone marrow recovered from deceased organ and tissue donors is safe and effective in patients undergoing bone marrow transplant (BMT). This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard of care for transplant. Bone marrow cells from a deceased organ and tissue donor in your transplant is the investigational treatment in this study and has not yet been approved by the Food and Drug Administration (FDA). This study is the first in human study that will use deceased...
A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants with Metastatic Castration-Resistant Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05553639

Population:

Adult

Phase:

I/II

The purpose of this study is to determine whether HB-302/HB-301 therapy is safe and well tolerated. This will be the first time HB-302/HB-301 will be tested in humans. HB-302/HB-301 has not yet been approved by the Food and Drug Administration (FDA) Are you Eligible? (Inclusion Criteria) Must be 18 years old or older. - Cannot have COVID positive result 6 weeks prior to study enrollment. - Must agree to use contraception during the study and through 5 months after the last dose of study drug

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