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An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT03328078

Population:

Adult

Phase:

I/II

This study is being done to test the orally administered study drug, CA-4948 in combination with ibrutinib in adult patients ages 18 and over diagnosed with relapsed or refractory (RR) Primary Central Nervous System Lymphoma (PCNSL). This study will take place at multiple centers globally. The study drug is thought to work by blocking a protein in your body called interleukin-1 receptor-associated kinase 4 (IRAK4). IRAK4 plays an essential role in some of the signaling pathways that are frequently not controlled in non-Hodgkin’s Lymphoma (NHL) and other hematological malignancies. When...
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 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 Platform Study of RAS(ON) Inhibitors in Patients with RASMutated Non-Small Cell Lung Cancer (NSCLC)

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06162221

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of an experimental drug called RMC-6291 or RMC-6236 in combination with pembrolizumab in non-small cell lung cancer (NSCLC). Both study drugs, RMC-6236 and RMC-6291, has not been approved by the Food and Drug Administration (FDA). Pembrolizumab is FDA approved but not in combination with RMC- 6291 or RMC-6236. You will be assigned to receive RMC-6291 in combination with pembrolizumab if you have an advanced cancer which has a mutation in a gene known as KRAS^G12C. You will be assigned to receive RMC-6236 in combination with pembrolizumab if you...
A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma orNon-Small Cell Lung Cancer

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05256290

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug, BDTX-1535, which is not yet approved by the United States Food and Drug Administration (FDA), in treating patients with advanced solid tumors with changes in a protein named epidermal growth factor receptor (EGFR), which may or may not help your condition during this study. However, it may help other patients in the future. Are you Eligible? (Inclusion Criteria) Adults 18 years of age or older or as permitted by applicable local regulations at the time of providing informed consent. 2. Life...
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 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...
LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of [177Lu]Lu-FAP-2286 in Patients with an Advanced Solid Tumor

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04939610

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of the experimental drugs called 68Ga-FAP-2286 and 177Lu-FAP-2286. 8Ga-FAP-2286 is an imaging agent that targets a certain protein which has been found in certain tumors called Fibroblast activation protein (FAP). Imaging using 68Ga-FAP-2286 will determine if participants are eligible to receive the experimental radiotherapy, 177Lu-FAP-2286, which researchers think may kill cancer cells by delivering radiation to cancer cells that have fibroblast activation protein (FAP). Are you Eligible? (Inclusion Criteria) Have you been diagnosed with...
Phase I/II trial of pembrolizumab and androgen-receptor pathway inhibitor with or without 225Ac-J591 for progressive metastatic castration resistant prostate cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04946370

Population:

Adult

Phase:

I/II

The main purpose of this study is to evaluate the maximum tolerated and recommended dose of pembrolizumab and an androgen-receptor pathway inhibitor with or without 225Ac-J591, to see what the side effects are and if they work for metastatic castration resistant prostate cancer. Pembrolizumab may help the body’s immune system fight tumor cells. It does this by keeping certain blood cells, called T cells, active so they can attack the cancer. T-cells are also part of your immune system. Thousands of patients have received pembrolizumab, but it is not approved for most patients with...
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...

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