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A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of BMS-986393 in Novel Combinations in Participants with Relapsed and/or RefractoryMultiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT06121843

Population:

Adult

Phase:

I

The purpose of this study is to test whether BMS-986393 in combination with other anti- cancer drugs is safe and effective at treating people with multiple myeloma (MM) that has come back after previous treatment (relapsed) or is not responding to current treatment (refractory). The researchers think that the combinations of alnuctamab, mezigdomide, or iberdomide with BMS-986393 in people with relapsed/refractory MM may improve their disease or keep their disease under control. This is an open-label, multicenter study that will recruit potential participants in the United States (USA) and...
A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Radiotherapy with or without Temozolomide and in Recurrent Glioblastoma as Single Agent

Principal Investigator:

Akiva Mintz, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05109728

Population:

Adult

Phase:

I

The purpose of the study is to evaluate the safety of Lutathera alone in patients with recurrent glioblastoma and the combination of Lutathera with radiotherapy with temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GB) and to establish the appropriate dose of this combination. Lutathera is a radioligand therapy, which is a targeted treatment that selectively delivers radiation to the tumor, with limited damage to surrounding tissues. Lutathera uses a radioactive particle (lutetium-177) attached to a targeting compound that binds to a specific protein on the tumor cells (...
A PHASE 1 OPEN-LABEL STUDY OF HER3-DXd (PATRITUMAB DERUXTECAN; U3-1402) IN COMBINATION WITH OSIMERTINIB IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC EGFR-MUTATED NON-SMALL CELL LUNG CANCER (NSCLC) (HER3-DXd [PATRITUMAB DERUXTECAN; U3-1402] IN

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04676477

Population:

Adult

Phase:

I

The purpose of this study is to determine the combination dose of patritumab deruxtecan and osimertinib that can be given to patients safely and to understand how well patritumab deruxtecan alone or in combination with osimertinib works to treat lung cancer. Osimertinib is an EGFR TKI therapy that targets EGFR mutations. Osimertinib has already been approved by several regulatory authorities for the treatment of patients with advanced non-small cell lung cancer whose tumors contain specific EGFR mutations. This will be the first time patritumab deruxtecan is used in combination with...
An Open-Label Phase 1b Study Evaluating the Safety and Efficacy of ABBV-383 in AL Amyloidosis

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT06158854

Population:

Adult

Phase:

I

The purpose of this study is to see how safe and effective is the study drug, ABBV-383. ABBV-383 works by binding to a specific protein called B-cell maturation antigen, which is found on the surface of cells affected by amyloidosis. By engaging T-cells, a type of white blood cell, ABBV-383 helps activate the immune response to target and remove the abnormal proteins that cause amyloidosis. The study drug ABBV-383, is not approved by the U.S Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years or older - Must consent to fresh pretreatment bone marrow...
A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3789 as Monotherapy and in Combination with Docetaxel in Participants with Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05639751

Population:

Adult

Phase:

I

The purpose of this research study is to test the safety of an investigational drug, PRT3789, at different dose levels to find out what effects, good and/or bad, PRT3789 has on Advanced or Metastatic Solid Tumors with a SMARCA4 Mutation. Mutations are changes or alterations in the DNA (genetic material) of your cells. A SMARCA4 mutation has been linked to certain cancers. Investigational means that the study drug is currently being tested and has not been approved for use by any health authority such as the United States (US) Food and Drug Administration (FDA) or any other health or...
Effects of MK-3475 on the breast tumor microenvironment in triple negative breast cancer with and without intra-operative RT: a window of opportunity study.

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT02977468

Population:

Adult

Phase:

I

Are you Eligible? (Inclusion Criteria) Participants must be/have: at least 21 years of age on the day of signing informed consent histologically proven invasive breast carcinoma with triple negative receptor status no evidence of metastatic disease no prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry adequate organ function
First-in-Human, Phase 1/1b, Open-label, Multicenter Study ofBifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapyand in Combination Therapy in Patients with EGFR-DrivenAdvanced Solid Tumors

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04429542

Population:

Adult

Phase:

I

This is a first-in-human clinical research study. This study is sponsored by a biopharmaceutical company named Bicara Therapeutics. The main purpose of this study is to investigate the study drug BCA101 alone and BCA101 in combination with pembrolizumab for its safety, the way the body absorbs, distributes, and gets rid of this study drug, how the study drug acts on the body, and whether it works on your cancer in patients with advanced cancer like you. Subjects will receive either BCA101 alone or BCA101 in combination with pembrolizumab until disease worsens, the subject stops benefitting...
Phase 1, window of opportunity study of parasympathetic stimulation with bethanechol in localized pancreatic adenocarcinoma prior to surgery.

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT03572283

Population:

Adult

Phase:

I

1. Are you 18 years of age or greater? 2. Do you have recurrent glioblastoma? 3. Is this the first or second time your glioblastoma reoccurred? 4. Did your first treatment include radiotherapy and temozolomide? Are you Eligible? (Inclusion Criteria) The purpose of this study is to determine whether the drug, bethanechol, could potentially be used in combination with surgery to decrease the chance of the cancer coming back after it is removed. Bethanechol is a medication that regulates the parasympathetic nervous system and is often used to manage the side effects of chemotherapy drugs and to...
Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection with ex vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells

Principal Investigator:

Pawel Muranski, MD

Contact Number:

212-342-5162

NCT Number:

NCT05183490

Population:

Adult

Phase:

I

The purpose of this study is to test whether giving an experimental cell product can treat viral infection in patients who have conditions that cause the poor function of their immune system. The patients with infections caused by viruses such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK and JC polyomaviruses (PyVs) virus may participate in this study. The cell product is called rapidly generated virus-specific T cells (R-MVST). R-MVST cells will be manufactured in our laboratory at Columbia University Irving Medical Center. This cell product has not been approved...
Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects with Advanced KRASG12C Mutant Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05462717

Population:

Adult

Phase:

I

The purpose of this study is to test a new drug called RMC-6291, to evaluate its safety at different doses, and to find out how the body processes it. RMC-6291 is a new experimental drug, which means that it is not approved by the US Food and Drug Administration (FDA) or any other health authorities. This is the first study in which RMC- 6291 will be tested in humans. Are you Eligible? (Inclusion Criteria) Must be 18 year old or older - Life expectancy of more than 3 months - Subjects must be able to take the study drug and retain by mouth

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