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An Open-Label Phase 1/2 Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis

Principal Investigator:

Rajshekhar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT06158854

Population:

Adult

Phase:

I/II

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 Multicenter Open-Label Study of RMC-6236 in Patients with Advanced Solid Tumors Harboring Specific Mutations in KRAS

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05379985

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to test an experimental drug called RMC-6236 (the study drug) for solid tumor cancer with a KRAS mutation. The KRAS protein sends signals that cause cancer cells to grow. RMC-6236 is designed to prevent the KRAS protein from sending these signals, and this blocking action may slow or stop the growth of your cancer cells. RMC-6236 is an experimental drug, which means that it is not approved by the United States (US) Food and Drug Administration (FDA) or any other health authorities. This is the first study in which RMC-6236 will be tested in humans. The safety of...
A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer

Principal Investigator:

Juan-Manuel Schvartzman, MD, PHD

Contact Number:

212-342-5162

NCT Number:

NCT05379595

Population:

Adult

Phase:

I/II

The purpose of this study is to see if the study drug,amivantamab (also known as Rybrevant TM) is safe and useful for treating patients with Colorectal Cancer (CRC) when it is given alone or in addition to standard-of-care chemotherapies (mFOLFOX6 or FOLFIRI), as well as to find the best dose of amivantamab when given with chemotherapies. Amivantamab is an antibody made from a protein, designed to target and eliminate a specific harmful object in your body, in this case, a cancer cell. Amivantamab works by targeting a protein in your body known as epidermal growth factor receptor (EGFR), that...
A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with

Principal Investigator:

Maria Diaz Ordonez, MD

Contact Number:

212-342-5162

NCT Number:

NCT05417594

Population:

Adult

Phase:

I/II

The main purpose of this study is to determine a dose of AZD9574 that is safe and tolerable (does not cause side effects that could prevent people from taking the drug) when given alone or in combination with temozolomide. The study will also evaluate how much of the study drug is in your blood at various times. In addition, the action of the study drug will be evaluated by measuring specific chemicals in the blood. All parts of this study are experimental which means AZD9574 is not approved by the U.S. Food and Drug Administration (FDA). This is the first time AZD9574 has been tested in...
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 Platform Study of RAS(ON) Inhibitors in Patients with Gastrointestinal Solid Tumors

Principal Investigator:

Gulam A. Manji, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT06445062

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of an experimental drug called RMC-6236 in combination with several chemotherapy medicines in patients with gastrointestinal cancers. The study will test the safety of RMC-6236 at different doses in combination with a fixed, standard dose of combination anti-cancer therapy, and how your body processes this combination. RMC-6236 is an investigational (experimental) drug, which means that it has not been approved by the United States (US) Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years old or older -...
A Phase I/IIa Randomized Clinical trial to Evaluate the Efficacy of EGFR-targeted, PNU159682-packaged Nanocells and Glycolipid-Packaged Nanocells in combination withGemcitabine and Nab-paclitaxel in Metastatic Pancreatic Ductal Adenocarcinoma

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT07049055

Population:

Adult

Phase:

I/II

The purpose of this study is to test a new experimental treatment for people with pancreatic cancer that has spread (metastatic PDAC). The experimental treatment being evaluated is called EGFR-targeted EnGeneIC Dream Vector™ (EDV™), carrying a drug called PNU-159682, or E-EDV-D682, referred to as the “study drug.” The study drug is investigational and has not been approved by the United States Food and Drug Administration (FDA). The study drug is a type of chemotherapy packaged inside a delivery vehicle (manufactured from a non–disease- causing salmonella...
A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT02332668

Population:

Pediatrics

Phase:

I/II

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have either advanced melanoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL) or advanced, relapsed or refractory programmed cell death ligand 1 (PD-L1) positive malignant solid tumor or other lymphoma. Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D. This study is being sponsored by the Children's...
An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis

Principal Investigator:

Rajshekhar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05451771

Population:

Adult

Phase:

I/II

The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in subjects with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis. Furthermore, the purpose of phase 2 part of this study is to compare the effectiveness of venetoclax and dexamethasone versus investigator’s choice treatment in this condition. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Can you comply with the procedures in this study, which include taking the study drug and extra clinic...
A Phase 1b/2 Study of AZD0120 (also known as GC012F), a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B cell Maturation Antigen in Participants with Relapsed or Refractory AL Amyloidosis

Principal Investigator:

Suzanne Lentzsch, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT07081646

Population:

Adult

Phase:

I/II

The purpose of this study is to learn more about whether AZD0120 is safe to administer to people with relapsed or refractory AL amyloidosis, those who haven't responded well to previous treatments. Relapsed means your AL amyloidosis has returned after a period of improvement. Refractory means your AL amyloidosis has not responded to treatment. We also want to see if AZD0120 can help treat this condition. This study will also help to better understand AL Amyloidosis and associated health problems. Are you Eligible? (Inclusion Criteria) Age greater than 18 years old - ECOG performance status of...

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