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Showing 1 - 10 of 23 Trials

A Randomized, Double-blind, Placebo-controlledPhase 3 Study to evaluate Dostarlimab as SequentialTherapy after Chemoradiation in Participants withLocally Advanced Unresected Head and NeckSquamous Cell Carcinoma

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT06256588

Population:

Adult

Phase:

III

The purpose of this study is to find out if an experimental drug, which is not approved by the United States Food and drug Administration, called dostarlimab given over the course of 1 year starting shortly after chemoradiotherapy (CRT) has finished, can delay or reduce the risk of cancer returning when compared to placebo given over the same time period following CRT. The experimental drug is being tested in participants with locally advanced unresected head and neck squamous cell carcinoma. Dostarlimab belongs to a class of drugs called PD-1 inhibitors. The immune cells in your body produce...
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants with Advanced Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04895709

Population:

Adult

Phase:

I/II

The main purpose of this study is to test the safety of the investigational drug, BMS-986340, administered alone and in combination with nivolumab. This study will investigate how patients with selected advanced solid tumors tolerate these drugs to identify the highest tolerable dose or the most suitable dose, explore any changes in your tumor, and your general health after receiving multiple doses of BMS-986340 alone or together with nivolumab. BMS-986340 is an immunotherapy antibody and an investigational research drug. Investigational drugs are drugs that are not yet approved by the Food...
A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 as a Single Agent and in Combination Therapy in Subjects with Selected Advanced Solid Tumors

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05098132

Population:

Adult

Phase:

I

The main purpose of this study is to determine the highest dose of STK-012 that can be given safely alone and in combination with a standard dose of pembrolizumab in subjects with advanced solid tumors, this will be assessed in the dose escalation phase of the study. In the dose expansion phase of the study, the highest dose of STK-012 that can be safely given in combination with pembrolizumab, as determined in the dose escalation phase, will be given to more people for further study.STK-012 is a modified (changed in the laboratory) form of a cytokine (protein) called interleukin-2 (IL-2)...
A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05973487

Population:

Adult

Phase:

I

The purpose of the study is to learn if the study treatments TSC-204-A0201, TSC 200- A020, and TSC-204-C0702 alone or in combination, referred to as T-Plex, are safe and effective in treating your type of cancer. T-Plex has not yet been approved by the Food and Drug Administration (FDA). This is a first-in-human study, which means that these products have never been administered to humans before. You are unlikely to benefit from taking part in this study. Are you Eligible? (Inclusion Criteria) Must be 18 years or older - Diagnosed with a locally advanced (unresectable) or metastatic solid...
A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination with Immuno-Oncology Agents in Subjects with Unresectable Advanced or Metastatic Solid Tumors

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05176483

Population:

Adult

Phase:

I

The purpose of this study is to evaluate the efficacy of the study drug, XL092 alone and/or in combination of other study drugs such as with nivolumab, nivolumab plus ipilimumab, or nivolumab/relatlimab fixed dose combination as a potential anticancer therapy to treat people with locally advanced or metastatic cancers including advanced renal cell cancer, castration-resistant prostate cancer, bladder cancer, liver cancer, lung cancer, colon cancer, head and neck cancer. Nivolumab has been approved as single agent for the treatment of melanoma, lung cancer, and bladder cancer and in...
Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05163041

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate whether the investigational drug, BT7480, will be a safe and effective anticancer therapy. This is the first time BT7480 will be given to humans. BT7480 is designed to recognize and attach itself to both the Nectin-4 protein found on the surface of some cancer cells and CD137, a protein found on the surface of some immune cells. BT7480 binds to both Nectin-4 and CD137 and may activate immune cells to fight the Nectin-4- expressing cancers. Are you Eligible? (Inclusion Criteria) Must be aged 18 years or older. Must have locally advanced or metastatic...
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...
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 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05252416

Population:

Adult

Phase:

I/II

This first-in-human study will evaluate the recommended dose, safety, and effects (good and bad) of an experimental drug, BLU-222, either alone or in combination with therapies approved for some types of cancer, including carboplatin, ribociclib, and fulvestrant, to find out if these are safe and effective ways to treat nonresectable (unable to be removed with surgery) advanced solid tumors, including ovarian, endometrial, and estrogen receptor positive (ER+) or human epidermal growth factor receptor 2 negative (HER2-) breast cancer. All subjects participating in this research study will...

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