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A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination with Pembrolizumab inPatients With Advanced or Metastatic Hepatocellular Carcinoma

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06600321

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of an investigational drug called ALN-BCAT, and find out what effects, if any, ALN-BCAT has on people with your type of liver cancer. The effects being studied include: • The frequency and severity of side effects (to determine if the drug is safe) • Whether ALN-BCAT may make tumors smaller • How ALN-BCAT may affect the genes and proteins in your cancer cells • How your body processes ALN-BCAT Are you Eligible? (Inclusion Criteria) Age 18 years or older - Patient able to understand and willing and able to comply with...
A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD6008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR Mutation (TIAN-SHAN1)

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06813365

Population:

Adult

Phase:

I

This study is a Phase 1 clinical trial, which means it is the first stage of testing a new drug in humans to evaluate its safety, determine how the body processes it, and identify any potential side effects. The drug being studied, DZD6008, is investigational, meaning it has not been approved by the U.S. Food and Drug Administration (FDA). This study is evaluating the study drug, DZD6008, in patients with advanced non small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation. EGFR is a protein that is important in regulating activities in cell proliferation...
A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced HepatocellularCarcinoma and Other Solid Tumors with Activating FGF/FGFR pathway aberrations (SURF-431)

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT06915753

Population:

Adult

Phase:

I

The purpose of this Study is to find out if an investigational drug, TYRA-430, is safe and effective at treating cancer in participants with locally advanced/metastatic liver cancer and other solid tumors tumors that have a certain mutation or alteration of a type of protein located on the surface of cancer cells. Investigational drug means that it has not been approved by the United States Food and Drug Administration (US FDA) to use or to treat any disease or cancer. This is the first time that the Study Drug has been used in people. Are you Eligible? (Inclusion Criteria) 18 years of age or...
A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects with Advanced KRAS Mutant Cancers

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06917079

Population:

Adult

Phase:

I

The purpose of this study is to find the best dose of the study drug, BBO-11818, when used alone (single therapy) and in combination with other standard of care treatments, and to see what effects, good or bad, the study drug has on participants. While the standard of care treatments, pembrolizumab, pemetrexed, cisplatin, carboplatin, and cetuximab are FDA-approved individually, the combination of BBO-11818 with these treatments is considered experimental. The study drug, BBO-11818, has not been approved by the U.S. Food and Drug Administration (FDA). This is the first time that BBO- 11818...
A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or“azer-cel”), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT03666000

Population:

Adult

Phase:

I

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers. PBCAR0191 is a new investigational treatment for certain types of cancer of the blood, such as leukemia and lymphoma. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill some types of cancer cells. Are you Eligible? (Inclusion Criteria) Must be 18 years of age or older Must have received at least 2...
A Controlled Multi-Arm Phase 1 Umbrella Study Evaluating the Safety and Feasibility of T-Cell Receptor Engineered Donor T-Cells Targeting HA-1 (TSC-100) or HA-2 (TSC-101) in HLA-A*02:01 Positive Subjects Undergoing Allogeneic Peripheral Blood Stem Cell

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT05473910

Population:

Adult

Phase:

I

The study involves research of two study drugs (TSC 100 and TSC 101), given in combination with the standard of care (SOC). The purpose of the study is to see if TSC 100 and TSC 101 are safe and effective in treating your blood cancer. The study also is measuring the effect of these study drugs on your immune system (immunogenicity of study drugs). TSC 100 and TSC-101 are experimental new study drugs that have not yet been approved by the US Food and Drug Administration (FDA) or regulatory authorities in any other countries. This is a first-in-human study, which means that these study drugs...
A Phase 1 Study of Lenalidomide in Combination with EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL)

Principal Investigator:

Jennifer Effie Amengual, MD

Contact Number:

212-342-5162

NCT Number:

NCT04301076

Population:

Adult

Phase:

I

Are you 18 years of age or older? Have you been diagnosed with human T-cell leukemia virus (HTLV)-associated adult T-cell leukemia-lymphoma (ATLL)? Are you able to make regularly scheduled visits to the clinic for treatment and examinations? Are you Eligible? (Inclusion Criteria) The purpose of this study is to test the safety and tolerability (side effects) of adding a study drug called lenalidomide at different doses in combination with the usual treatment with EPOCH chemotherapy. “Dose” is defined as the amount of drug a patient gets, such as 15 mg. These drugs have already...
A Phase 1, Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®819 in Subjects with Relapsed or Refractory Clear Cell Renal Cell Carcinoma

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05433142

Population:

Adult

Phase:

I

The purpose of this study is to assess whether an investigational drug called XmAb819 has any effects on Clear Cell Renal Cell Carcinoma, to determine if it is safe and well tolerated, and to determine the dosing schedule. The investigational drug will be given by intravenous (IV – into the vein) infusion over a 2 hour period. This study will also see how the body affects the study drug and how much study drug is in the blood (pharmacokinetics, or “PK”), how the drug affects the tumor and body (pharmacodynamics, or “PD”), and if the body develops antibodies...
A Feasibility Study Examining the Use of Non-Invasive Focused Ultrasound (FUS) with oral Etoposide Administration in Children, Adolescents, and Young Adults with Progressive Diffuse Midline Glioma (DMG)

Principal Investigator:

Stergios Zacharoulis, MD

Contact Number:

212-342-5162

NCT Number:

NCT05762419

Population:

Pediatrics/Adult

Phase:

I

Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY® microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine whether there are any clinical benefits of the study treatment. Children with progressive diffuse midline gliomas (DMGs) have very poor outcomes and have very limited options. One of the main obstacles in the effectiveness of medical...
A Phase 1 Study of PF-08046040/SEA-CD70 in MyeloidMalignancies

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT04227847

Population:

Adult

Phase:

I

You are being asked to participate in this study because you have Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and we are testing the study drug’s, SEA-CD70, to find out what its side effects are and to see if the study drug is safe for people with these types of cancer. are testing to see if SEA- CD70 is safe for people, and its side effects. SEA-CD70 is a type of drug called an antibody. Antibodies are part of your immune system. Usually they help protect you from getting sick. The purpose of this study is to use study drug SEA-CD70, and while using another antibody...

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