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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 First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased DonorBone Marrow Transplantation for Patients with Hematologic Malignancies (PRESERVE I)

Principal Investigator:

Markus Y Mapara, MD

Contact Number:

212-342-5162

NCT Number:

NCT05589896

Population:

Adult

Phase:

I/II

The purpose of the study is to learn if a transplant using bone marrow recovered from deceased organ and tissue donors is safe and effective in patients undergoing bone marrow transplant (BMT). This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard of care for transplant. Bone marrow cells from a deceased organ and tissue donor in your transplant is the investigational treatment in this study and has not yet been approved by the Food and Drug Administration (FDA). This study is the first in human study that will use deceased...
A Phase Ib/II, Open-Label, Multicenter, Randomized Platform Study Evaluating The Efficacy and Safety of Neoadjuvant Immunotherapy Combinations in Patients with Surgically Resectable Hepatocellular Carcinoma (Morpheus-Neo-HCC)

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05908786

Population:

Adult

Phase:

I/II

The purpose of this study is to compare the effects, good or bad, of the cancer immunotherapy (CIT) combinations on you and your liver cancer, to find out which is better when given prior to surgery to remove your cancer. The study drugs are Atezolizumab, Bevacizumab, Tiragolumab, and RO7247669.The CIT combinations are experimental drug treatments, which means health authorities have not approved them for the treatment of liver cancer in the neoadjuvant for treating cancer before surgery. Are you Eligible? (Inclusion Criteria) • Signed Informed Consent Form • Age ≥ 18 years at...
A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination with Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT03604978

Population:

Adult

Phase:

I/II

Phase 2, Treatment A: This study is being done to see if your recurrent brain tumor may respond to a combination of radiosurgery (a type of radiation therapy) with nivolumab (a type of immunotherapy drug). A small number of patients have already received this combination previously and have tolerated the treatment relatively well. However, we would like to see if the combination treatment may be better or worse than the standard approach of radiosurgery alone. We would also want to learn more about the side effects associated with giving nivolumab with radiosurgery. Phase 2, Treatment B: This...
A Phase 1b/2, Randomized, Open-Label Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine as Maintenance Therapy in Patients With

Principal Investigator:

Yoanna S Pumpalova, MD

Contact Number:

212-342-5162

NCT Number:

NCT05609370

Population:

Adult

Phase:

I/II

The purpose of this study is safety, tolerability and efficacy of a combined treatment of LBL-007 and tislelizumab in combination with bevacizumab and capecitabine. LBL-007 and tislelizumab has not yet been approved by the Food and Drug Administration (FDA). Bevacizumab and capecitabine are approved for use in colorectal cancer, but their use in combination with LBL- 007 alone or LBL-007 in combination with tislelizumab is not. Tislelizumab affects cells in your immune system, making them more likely to attack cancer cells. Tislelizumab does this by binding to a part of your immune cells...
A Phase 1/2 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, andEfficacy of AMG 193 in Combination With IDE397 in Subjects With Advanced MTAP-null SolidTumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05975073

Population:

Adult

Phase:

I/II

The purpose of this study is to assess how the study drugs, AMG 193 and IDE397, move throughout the body, how the study drugs work in the body, whether they are safe, and an effective treatment option for people with advanced solid tumors lacking methylthioadeosine phosphorylase (MTAP) in the DNA (genetic material). Lacking MTAP may limit the way in which the enzyme, protein arginine methyltransferase 5 (PRMT5) works. PRMT5 is important for cancer cell survival and works with an enzyme methionine adenosyltransferase 2A (MAT2A). AMG193 may further slow down PRMT5 activity and kill cancer cells...
A Phase I/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti tumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05914116

Population:

Adult

Phase:

I/II

DB-1311 (study drug) is an investigational antibody-drug conjugate (antibody that guides the study drug to cancer cells) composed of an anti-B7-H3 (a protein associated with worse overall survival and drug resistance) antibody and P1021 (slows DNA replication in cancer cells). Investigational means the study drug being tested is not approved by the United States (U.S.) Food and Drug Administration (FDA). The main goal of this study is to test whether the study drug is safe and tolerable in patients with certain types of cancer. This study will also measure the amount of the study drug in...
A Platform Study of RAS(ON) Inhibitor Combinations in Patients with RAS-Mutated 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

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 1B/2, MULTICENTER, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXd), A B7-H3 ANTIBODY-DRUG CONJUGATE (ADC), IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE, IN SUBJECTS WITH EXTENSIVE-STAGE

Principal Investigator:

Lanyi Nora Chen, MD

Contact Number:

212-342-5162

NCT Number:

NCT06362252

Population:

Adult

Phase:

I/II

The purpose of this study is to learn more about an investigational drug, which is not approved by the United States Food and Drug Administration, called ifinatamab deruxtecan (I-DXd). It is being studied to see if it is safe and if your disease, extensive- stage small cell lung cancer (ES-SCLC), or other medical condition improves while taking it alongside other drugs, Atezolizumab, Carboplatin, and Etoposide. I-DXd is a type of drug called an antibody-drug conjugate, which is made up of 2 parts: an antibody and an anticancer drug. The antibody part binds to a protein commonly found on tumor...

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