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LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of [177Lu]Lu-FAP-2286 in Patients with an Advanced Solid Tumor

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04939610

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of the experimental drugs called 68Ga-FAP-2286 and 177Lu-FAP-2286. 8Ga-FAP-2286 is an imaging agent that targets a certain protein which has been found in certain tumors called Fibroblast activation protein (FAP). Imaging using 68Ga-FAP-2286 will determine if participants are eligible to receive the experimental radiotherapy, 177Lu-FAP-2286, which researchers think may kill cancer cells by delivering radiation to cancer cells that have fibroblast activation protein (FAP). Are you Eligible? (Inclusion Criteria) Have you been diagnosed with...
An open-label, multi-center phase I/Ib dose finding and expansion study of HRO761 as single agent and in combinations in patients with Microsatellite Instability-High or Mismatch Repair Deficient advanced solid tumors

Principal Investigator:

Edmond M. Chan, MD

Contact Number:

212-342-5162

NCT Number:

NCT05838768

Population:

Adult

Phase:

I

The main purpose of the study is to find the optimal dose of HRO761 alone or in combination with tislelizumab or irinotecan that can be given to people with certain cancer types called MSI high or dMMR. The new drug being tested in the study, HRO761, is an oral drug that is called a “targeted medicine”: this means that it targets particular processes which may not be working properly in the cancer cells in a participant's body and causing their disease. This is the first time HRO761 is given to people and the first time HRO761 is used in combination with tislelizumab or irinotecan...
A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, andPreliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination withPembrolizumab in Patients with Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05128487

Population:

Adult

Phase:

I/II

The purpose of this study is to find out if a new investigational drug NDI-101150 is safe when given alone and in combination with pembrolizumab, and to look at the pharmacokinetics (PK, to measure how your body takes up, breaks down, and clears NDI- 101150) and the antitumor activity (to measure how NDI-101150 works in your tumors). Investigational means the drug has not been approved by the Food and Drug Administration (FDA). This is the first time that NDI-101150 is being tested in humans. NDI-101150 is a small molecule inhibitor of HPK1 (a protein that weakens the immune system). It is...
A Phase 1/2 First-in-Human Study of the Safety and Efficacy of IMC-F106C as a Single Agent and in Combination with Checkpoint Inhibitors in HLA-A*02:01-Positive Participants with Advanced PRAME-Positive Cancers

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04262466

Population:

Adult

Phase:

I/II

This is a research study to determine how safe and effective a new treatment, called IMC-F106C, is for treating advanced cancers. This study is the first time the study drug is being tested in people. IMC-F106C has been developed to treat cancer by activating the body’s own immune system to fight the tumor. The study drug has 2 parts. The first part, called a “T cell receptor”, sticks very tightly to tumor cells that make markers called “HLA-A*02:01” and “PRAME”. The second part, called “anti-CD3 scFv”, sticks to a T cell (a type of white...
A Study of PARG Inhibitor IDE161 in Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05787587

Population:

Adult

Phase:

I

The purpose of this study is to find out if the experimental study drug called IDE161 used alone is safe and helpful in solid tumors known to be caused by an error in genes that repair DNA. Cells have different ways to repair damaged DNA. Experimental means that the study drug has not been approved by any regulatory authorities, including the U.S. Food and Drug Administration (FDA) .IDE161 may block the ability of a protein called Poly(ADP-ribose) glycohydrolase (PARG) from properly functioning. PARG is an important protein in a different DNA repair pathway called Base Excision Repair (BER)...
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
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF ORAL MRT-2359 IN PATIENTS WITH MYC-DRIVEN AND OTHER SELECTED SOLID TUMORS INCLUDING LUNG CANCER AND DIFFUSE LARGE B-CELL LYMPHOMA

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05546268

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety and confirm the best dose in humans for an investigational drug called MRT-2359 in subjects with solid tumors and diffuse large B-cell lymphoma. “Investigational” means the study drug has not been approved for the treatment of participants with cancer by the Food and Drug Administration (“FDA”) or any other health/regulatory authority anywhere in the world.MRT-2359 is called a molecular glue degrader or MGD. This MGD can selectively stick to a protein called G1 To S Phase Transition 1 (GSPT1) and cause GSPT1 to...
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

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 I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT04068194

Population:

Adult

Phase:

I/II

This study is being done to answer the following question: Is M3814 in combination with radiation therapy and avelumab safe and tolerable in patients with advanced or metastatic cancers. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your advanced or metastatic cancer. The usual approach is defined as care most people get for advanced or metastatic solid tumor. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have a tumor which has spread to other parts of your body or that has advanced and...
A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination with Pembrolizumab in Selected Advanced Solid Tumors

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05585034

Population:

Adult

Phase:

I

The purpose of this study is to assess whether an investigational drug, called XmAb808, given in combination with pembrolizumab, has any effects on your cancer, to determine the best dose of XmAb808 to treat your cancer, and if it is safe and well tolerated. XmAb808 is an investigational drug being developed for the treatment of advanced solid tumors. An investigational drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA), the health authority that approves new medicines to be prescribed in the United States. Are you Eligible? (Inclusion Criteria) Subject...

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