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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...
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
Phase 1/Expansion Study of Tazemetostat Plus Belinostat for the Treatment of Relapsed or Refractory Lymphoma

Principal Investigator:

Jennifer Effie Amengual, MD

Contact Number:

212-342-5162

NCT Number:

NCT05627245

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of drugs called tazemetostat and belinostat when administered together. This study tests different doses of the drugs to see which doses are safer for people. There will be between 21 and 48 people taking part in this study. There are two parts in this study, a dose escalation (dose finding) part and a dose expansion part (where the established dose is tested further). In the dose escalation part of this study, different people will get different doses of the study drugs tazemetostat and belinostat. The first 3 people taking part in this study...
Phase I trial of ZEN003694 (ZEN-3694) in combination with capecitabine in patients with solid tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05803382

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of a drug called ZEN003694 (ZEN-3694), in combination with the usual approach of capecitabine. This study tests different doses of ZEN003694 in combination with capecitabine to see which dose is safer for people. There will be between 21 and 30 people taking part in this study. This drug combination is not approved by the FDA for treatment of the disease being studied. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Have you been diagnosed with metastatic or unresectable cancer, which progressed while you were treated...
Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP6306 Alone or in Combination with RP-3500 or Debio 0123 in Patients with Advanced Solid Tumors (MYTHIC Study)

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04855656

Population:

Adult

Phase:

I

The purpose of this research study is to test how safe RP-6306 is at different doses and schedules, test how well RP-6306 works to shrink cancer in the body, and evaluate if food affects the way RP-6306 moves through your body. This study will test the investigational drug, RP-6306, for the first time in humans. “Investigational” means that the study drug being tested has not been approved by the United States Food and Drug Administration (FDA). RP- 6306 is a PKMYT1 inhibitor (blocks the activity of the PKMYT1 protein) that is designed to stop certain cancer cells from growing...

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