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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 1/2 study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT03947385

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety profile of IDE196 (an “investigational” drug), in enrolled subjects to find out if it is safe and possibly helpful in patients with certain cancers such as: metastatic uveal melanoma, cutaneous melanoma or colorectal cancer or cancers with mutations in genes called GNAQ, GNA11, or PRKC fusion. The study may last for approximately 25 months and your participation will depend on how well you tolerate the study drug and your overall condition during the study. Are you Eligible? (Inclusion Criteria) Do you have a solid tumor(s) that...
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...
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...
Phase 1b, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRASG12C-Mutated Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06128551

Population:

Adult

Phase:

I/II

The purpose of this study is to test a combination of 2 new drugs called RMC-6291 and RMC 6236 (the study drugs). RMC-6291 and RMC-6236 are new investigational (ie, experimental) drugs, which means that they are 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 6291 and RMC-6236 will be tested together in humans. This study will test the safety and anti-tumor effects of RMC-6291 and RMC-6236 when given together at different doses in participants with a change or alteration in the KRASG12C gene within...
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, 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...

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