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An open-label, multicenter, dose escalation and expansion phase 1/2 study to evaluatethe safety, tolerability and pharmacokinetics, and anti-tumor activity of GI-102, a CD80-IgG4Fc-IL-2v bispecific fusion protein, as a single agent and in combination with

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT05824975

Population:

Adult

Phase:

I/II

This study will see if the study drug, GI-102, alone or in combination with conventional anti- cancer drugs, pembrolizumab or trastuzumab deruxtecan, has an effect on the tumor and whether it causes any side effects. This study is to test study drugs in people with all types of solid tumors (certain tumor types for some groups). Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but is not approved to treat all types of cancer in this study. GI-102 is still experimental and is not approved by any regulatory...
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...
Phase I/II trial of pembrolizumab and androgen-receptor pathway inhibitor with or without 225Ac-J591 for progressive metastatic castration resistant prostate cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04946370

Population:

Adult

Phase:

I/II

The main purpose of this study is to evaluate the maximum tolerated and recommended dose of pembrolizumab and an androgen-receptor pathway inhibitor with or without 225Ac-J591, to see what the side effects are and if they work for metastatic castration resistant prostate cancer. Pembrolizumab may help the body’s immune system fight tumor cells. It does this by keeping certain blood cells, called T cells, active so they can attack the cancer. T-cells are also part of your immune system. Thousands of patients have received pembrolizumab, but it is not approved for most patients with...
PHASE 1/2 STUDY OF LINVOSELTAMAB (ANTI-BCMA X ANTI-CD3BISPECIFIC ANTIBODY) IN PREVIOUSLY UNTREATED PATIENTSWITH SYMPTOMATIC MULTIPLE MYELOMA

Principal Investigator:

Rajshekhar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05828511

Population:

Adult

Phase:

I/II

This study is looking at people who have recently been newly diagnosed with a type of cancer called multiple myeloma (NDMM). The purpose of this study is to learn about the safety, tolerability (how your body reacts to the study drug), and effectiveness (tumor shrinkage) of linvoseltamab (called “study drug”) in participants with NDMM as a first step in determining if the study drug has a role to play in the treatment of NDMM. This study consists of 2 phases. Your study doctor will tell you which phase of the study you will be participating in. Are you Eligible? (Inclusion...
R4018-ONC-1721: A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

Principal Investigator:

June Y. Hou, MD

Contact Number:

212-342-5162

NCT Number:

NCT03564340

Population:

Adult

Phase:

I/II

The main purpose of this study is to: • Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or in combination with cemiplimab to research subjects with ovarian cancer without too many side effects. • The study will also look at the levels of REGN4018 and/or cemiplimab in the body and measure how well your body can remove the study drug(s). This is called pharmacokinetics. • The study will also look at any signs that REGN4018 alone or with cemiplimab can treat cancer. Are you Eligible? (Inclusion Criteria) Do you have ovarian cancer? Are...
An Open-Label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, inAdvanced Solid Tumor Malignancies with SMARCA4/BRG1 Alterations- J5M-OX-JOXA

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06561685

Population:

Adult

Phase:

I

The purpose of this study is to test the safety of an investigational treatment called LY4050784 in subjects with solid tumors that have a particular genetic abnormality (called an alteration or mutation) of a gene called SMARCA4 and/or BRG1. LY4050784 is an investigational (or experimental) drug, taken by mouth that targets a gene called SMARCA2/BRM, and may treat certain cancers. Investigational means neither the FDA nor any other health or regulatory authority in other countries have approved LY4050784. This study will be the first time LY4050784 will be tested in humans. Are you Eligible...
A Phase 1a/1b Study of the pan-KRAS Inhibitor LY4066434 in Participants with KRAS Mutant SolidTumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06607185

Population:

Adult

Phase:

I

This research study is being done to test the safety of an investigational treatment called LY4066434 when given alone or with other cancer drugs. LY4066434 is an investigational (or experimental) drug, taken orally. It was designed for patients that have abnormalities (also known as DNA mutations) in the KRAS gene that can occur in some types of cancer. LY4066434 is not approved by the U.S. Food and Drug Administration. Are you Eligible? (Inclusion Criteria) Must be ≥18 years of age, 2. Must be able to swallow tablets. 3. Must be able to comply with outpatient treatment, laboratory...
A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Principal Investigator:

Hua-Jay J Cherng, MD

Contact Number:

212-342-5162

NCT Number:

NCT04970901

Population:

Adult

Phase:

I

This study will look at the safety, effectiveness (efficacy) and tolerability of an investigational drug called loncastuximab tesirine in combination with other anti-cancer drugs polatuzumab vedotin, glofitamab and mosunetuzumab for patients with relapsed or refractory B-cell Non- Hodgkin Lymphoma. Loncastuximab tesirine is an antibody drug conjugate (ADC), which is a type of medicine that combines an antibody (a protein that binds to specific substances in the body) with a chemotherapy drug that can kill cells. The antibody part of the study drug potentially helps direct the chemotherapy to...
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...
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...

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