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An open-label, multi-center, non-randomized phase I dose escalation study to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ONO-4685 given as monotherapy in patients with relapsed or refractory T-cell Lymphoma

Principal Investigator:

Barbara Pro, MD

Contact Number:

212-342-5162

NCT Number:

NCT05079282

Population:

Adult

Phase:

I

The purpose of this study is to find out the safety, effectiveness, and blood levels of various doses of the study drug in participants with T-cell lymphoma that has not improved or has gotten worse. ONO-4685 is an experimental drug which is not approved by Health Authorities including United States Food and Drug Administration (FDA). The study drug is a protein made in laboratory called an antibody. Antibodies are made naturally in our body and are a key part of our immune system. The study drug antibody targets 2 specific proteins: a protein called PD-1 on cancer cells and protein Are you...
An open-label, Phase 1b study to evaluate the safety andtolerability of eflornithine plus temozolomide in patients with newly diagnosed glioblastoma or astrocytoma

Principal Investigator:

Maria Diaz Ordonez, MD

Contact Number:

212-342-5162

NCT Number:

NCT05879367

Population:

Adult

Phase:

I

The purpose of this study is to measure how safe eflornithine is in combination with temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM) following radiation therapy. Safety and tolerability will be determined on the basis of physical exams, laboratory tests, and questions about any problems you might experience during the study.This study will also measure levels of eflornithine in patients following dosing, and it will evaluate how effective eflornithine is as a treatment of GBM when combined with temozolomide. Eflornithine is an experimental drug, which means that it...
A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS ASINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTSIN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05538130

Population:

Adult

Phase:

I

The purpose of this study is to learn about the safety (the impact of the study drug on your body) and the effects of study drug PF-07799544 for specific types of cancer on the body and to find the best dose for treating certain cancers. For BRAF (B-raf proto-oncogene serine/threonine kinase) mutated solid tumors, PF-07799544 may be combined with encorafenib, also known as BRAFTOVI® (an FDA approved cancer medication). The study drug PF-07799544 is an investigational drug because it is not FDA approved for use in this country. The study drug encorafenib is approved in this country and is...
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...
An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT04794699

Population:

Adult

Phase:

I

IDE397 is an investigational drug, which has not been approved by health authorities for the treatment of people with your medical condition. It is currently not “on the market” (available for you to receive a prescription for and/or to buy) in any country. In this study, different dose levels of IDE397 will be tested. About 40 patients are expected to participate at approximately 6-8 study centers within the US. At a minimum, 2 patients will be enrolled in each dose level. There will be about 10 dose levels tested (starting at 5 mg). Every time a dose level is found to be safe, a...
A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04898634

Population:

Adult

Phase:

I

You are being invited to take part in a research study that includes studying JNJ-78278343 in subjects with prostate cancer. This is an investigational drug which means that this is a new approach for the treatment of people who have prostate cancer. The main purpose of this study is to find a safe dose of JNJ- 78278343 that can be used in the treatment of prostate cancer. To do this, we must find out if JNJ-78278343 can cause side-effects. Also, we need to find out how long JNJ-78278343 stays in and acts on your body and how your body responds to it. Prostate cancer is known to have high...
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 First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05216432

Population:

Adult

Phase:

I

This research study is designed to learn about the safety of an experimental (investigational) drug called RLY-2608, also called the study drug, when given to individuals who have been diagnosed with metastatic (spread to other areas of the body) or unresectable (cannot be removed surgically) cancers and have at least one mutation in a gene called PIK3CA. “Investigational” means that it is not yet known if this drug helps patients, has not been approved by the Food and Drug Administration (FDA) or any other regulatory agency, and is not available for sale as a marketed product...
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...

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