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A PHASE 1, MULTI-CENTER, OPEN-LABEL,DOSE-FINDING STUDY TO EVALUATE THE SAFETY,TOLERABILITY, PHARMACOKINETICS, ANDPHARMACODYNAMICS OF CC-94676 IN SUBJECTSWITH METASTATIC CASTRATION-RESISTANTPROSTATE CANCER

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT04428788

Population:

Adult

Phase:

I

You are being asked to take part in this study because you have been diagnosed with advanced prostate cancer and the standard drugs to treat your disease (metastatic castration-resistant prostate cancer [mCRPC]) are no longer effective or no effective treatment is known for your type of cancer. This research study will test an investigational drug called CC-94676 (the study drug; also known as BMS-986365). Investigational means the study drug being tested has not been approved by the United States Food and Drug Administration (FDA). CC-94676 is a new experimental drug developed by the sponsor...
A Phase 1 Study of DSP-0390 in Patients with RecurrentHigh-Grade Glioma

Principal Investigator:

Mary R. Welch, MD

Contact Number:

212-342-5162

NCT Number:

NCT05023551

Population:

Adult

Phase:

I

The purpose of this study is to evaluate how safe the investigational drug, DSP-0390, is at different doses and to identify a recommended dose that is safe for further study. Investigational means that the study drug is currently being tested and has not been approved for use alone or in combination with any drug by the U.S. Food and Drug Administration (FDA) or any other health or regulatory authority in other countries. DSP- 0390 is an oral drug that is being tested in people with high grade glioma. This drug may help to inhibit or block emopamil binding protein (EBP), a protein that is...
A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

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...
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...
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 inpatients 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...
A Phase 1 Clinical Trial of CA-4948 in Combination with Gemcitabine and Nab-Paclitaxel in Metastatic or Unresectable Pancreatic Ductal Carcinoma

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT05685602

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of a drug called CA-4948 in combination with gemcitabine and nab-paclitaxel. This study tests different doses of the drug CA-4948 to see which dose is safer for people. There will be about 36 people taking part in this study. CA- 4948 is not approved by the FDA for treatment of pancreatic cancer. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have pancreatic cancer which has progressed after previous chemotherapy treatment? Are you able to make extra visits to the clinic for treatment and assessments?
A Phase 1 Open-label, Multicenter Study Evaluating theSafety and Efficacy of KITE-363 or KITE-753, AutologousAnti-CD19/CD20 CAR T-cell Therapies, in Subjects WithRelapsed and/or Refractory B-cell Lymphoma

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT04989803

Population:

Adult

Phase:

I

You have been invited to participate in this study because you have relapsed and/or refractory B-cell lymphoma and standard therapies available to treat your disease have limited effectiveness. The purpose of this study is to find out if the experimental products, KITE-363 and KITE-753, are safe and effective in treating your relapsed and/or refractory B-cell lymphoma. Participants will receive either KITE-363 or KITE-753 one time through into the vein (IV) infusion. The experimental treatment would involve removing some of your immune cells, genetically engineering those cells to identify...
A Phase 1a/1b Trial in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a fenretinide phospholipid suspension (12.5 mg/mL) for Intravenous Infusion

Principal Investigator:

Barbara Pro, MD

Contact Number:

212-342-5162

NCT Number:

NCT04234048

Population:

Adult

Phase:

I

The purpose of this study is to see what effects, good and/or bad, the study drug, ST-001, has on you and your cancer, to find the best dose for treating your condition, and to see how safe ST-001 is for participants with your condition. This study will help us understand more about whether intravenous (injected into the vein) ST-001, will be a useful study treatment for subjects with Relapsed/Refractory T-cell Non-Hodgkin Lymphoma (T-Cell NHL). Relapsed or refractory disease means your disease that has come back after initial treatment or did not respond to initial treatment. Approximately...
A phase 1 study of JNJ-86974680, an A2a receptor antagonist, administered asmonotherapy and in combination with cetrelimab and radiotherapy for advanced nonsmallcell lung cancer

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT06116786

Population:

Adult

Phase:

I

The purpose of this study is to find out if JNJ-86974680 taken by itself or together with Cetrelimab and radiotherapy can cause side effects which are unexpected or unwanted reactions. This is the first time that JNJ-86974680 is being used in people. Radiotherapy is also part of the study treatment and not part of your standard of care. JNJ-86974680 and Cetrelimab are experimental drugs and not approved by the Food and Drug Administration (FDA). JJNJ-86974680 is a small molecule that may block adenosine function. Adenosine is a chemical in the body that can reduce the ability of your immune...
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined with JNJ 78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06095089

Population:

Adult

Phase:

I

The purpose of this study is to find out the side effects of JNJ-87189401 given in combination with JNJ-78278343 to patients with metastatic castration-resistant prostate cancer, and to find which doses of the two study drugs when given in combination cause the least side effects. The study will also look at how long JNJ-87189401 and JNJ-78278343 stay in the body, how they act on the body, and how the body responds to them. JNJ-87189401 and JNJ-78278343 have not been approved by the Food and Drug Administration (FDA). This is the first time that JNJ-87189401 will be used in people. JNJ-...

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