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A Phase I/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti tumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05914116

Population:

Adult

Phase:

I/II

DB-1311 (study drug) is an investigational antibody-drug conjugate (antibody that guides the study drug to cancer cells) composed of an anti-B7-H3 (a protein associated with worse overall survival and drug resistance) antibody and P1021 (slows DNA replication in cancer cells). Investigational means the study drug being tested is not approved by the United States (U.S.) Food and Drug Administration (FDA). The main goal of this study is to test whether the study drug is safe and tolerable in patients with certain types of cancer. This study will also measure the amount of the study drug in...
A Phase I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, aChimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participantswith Metastatic Prostate Cancer: APOLLO

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06267729

Population:

Adult

Phase:

I/II

The purpose of this study whether AZD0754 is safe to administer to people with prostate cancer that has spread to other parts of your body (metastatic) and whether it can help to treat their type of cancer. AZD0754 is a type of study treatment called chimeric antigen receptor or CAR T-cell therapy. It uses cells from the subject's own immune system, called T-cells, to attack cancer cells. AZD0754 has not been approved by the Food and Drug Administration (FDA). This is a first in human study. A few days before AZD0754 infusion, the subject will have chemotherapy to lower the number of white...
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 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04851119

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find out what dose of tegavivint should be used with children and how well it works when given to patients between the ages of 12 months to 30 years of age with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas, osteosarcomas, liver tumors (HCC and hepatoblastoma), Wilm's tumor and tumors with Wnt pathway aberrations. Tegavivint is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of children with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas,...
A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04870944

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find the highest dose of CBL0137 that can be given safely to patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory) solid tumors, including the CNS tumors and lymphoma. CBL0137 will be given into a vein on Day 1 and Day 8 of a 21 day cycle for up to 17 cycles, which will last about 24 months. Are you Eligible? (Inclusion Criteria) Inclusion Criteria: Part A: Patients must be at least 1 year of age and 21 years of age, have been diagnosed with relapsed or refractory relapsed or refractory solid tumors or lymphoma...
An open-label, multicenter, dose escalation and expansion phase 1/2 study to evaluatethe safety, tolerability and pharmacokinetics, and anti-tumor activity of GI-102, a CD80-IgG4Fc-IL-2v bispecific fusion protein, as a single agent and in combination with

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT05824975

Population:

Adult

Phase:

I/II

This study will see if the study drug, GI-102, alone or in combination with conventional anti- cancer drugs, pembrolizumab or trastuzumab deruxtecan, has an effect on the tumor and whether it causes any side effects. This study is to test study drugs in people with all types of solid tumors (certain tumor types for some groups). Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but is not approved to treat all types of cancer in this study. GI-102 is still experimental and is not approved by any regulatory...
A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT06634589

Population:

Adult

Phase:

I/II

Treatments for B cell cancers that return or are hard to treat often do not last long. Even when patients improve at first, the cancer usually comes back. Drugs called Bruton’s tyrosine kinase (BTK) inhibitors have helped people with conditions such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia (WM), marginal zone lymphoma (MZL), and follicular lymphoma (FL). However, these drugs cannot fully stop the disease, because cancer cells can change and resist treatment. This study is testing BGB...
A Phase 1/2 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/II

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...
A Pilot/Randomized Phase II Trial of Rituximab in Addition to Standard of Care for the Prevention of Post-Transplant Lymphoproliferative Disorder in Solid Organ Transplant Recipients with EBV DNAemia

Principal Investigator:

Jennifer Effie Amengual, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

I/II

People who have received a solid organ transplant can develop ongoing Epstein–Barr virus (EBV) infection in the blood, which increases the risk of a serious cancer called post‑transplant lymphoproliferative disorder (PTLD). This study will test whether rituximab, a drug approved by the U.S. Food and Drug Administration (FDA) for several immune‑related conditions, can safely clear EBV from the blood and help prevent PTLD when lowering immune‑suppressing medications is not possible or effective. The study includes an initial smaller group focused on determining whether EBV can be cleared...
A Phase 1/2 Study of nula-cel in Autologous CD34+ Hematopoietic Stem Cells to Convert HbS to HbA for Treating Severe Sickle Cell Disease

Principal Investigator:

Markus Y Mapara, MD

Contact Number:

212-342-5162

NCT Number:

NCT04819841

Population:

Adult

Phase:

I/II

In this study includes studying nula-cel (nulabeglogene autogedtemcel, also referred to as KMAU001) in sickle cell disease (SCD). Some of your blood stem cells will be collected and sent to a lab for gene correction and editing. The lab will use a process to change the mutated beta-globin gene into a normal beta-globin gene in the blood stem cells. The corrected cells are called nula-cel , which is the study drug product (DP) in this study. Your DP is made only for you. It will not be given to anyone else. The purpose of this study is to find out whether this gene correction process improves...

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