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MORAb-202-G000-201: A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) in Subjects With Selected Tumor Types

Principal Investigator:

June Y. Hou, MD

Contact Number:

212-342-5162

NCT Number:

NCT04300556

Population:

Adult

Phase:

I/II

The purpose of the first part of this study, the Dose Escalation part, is to study and identify the highest tolerable safe dose of MORAb-202. The purpose of the Expansion part is to further investigate how the different tumor types being studied respond to the study drug and to gather more information on its safety and effectiveness. This study will enroll patients with triple-negative breast cancer (TNBC), endometrial cancer (EC), non-small cell lung cancer (NSCLC, adenocarcinoma), and ovarian cancer. If it is determined that you meet all of the study entry requirements, you will get an...
PHASE 1/2 STUDY OF LINVOSELTAMAB (ANTI-BCMA X ANTI-CD3BISPECIFIC ANTIBODY) IN PREVIOUSLY UNTREATED PATIENTSWITH SYMPTOMATIC MULTIPLE MYELOMA

Principal Investigator:

Rajshekar 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 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-186 (also known as MVC-101), An EGFR x CD3 COnditional Bispecific Redirected Activation (COBRA) Protein in Patients with Unresectable Locally Advanced or Metastatic Cancer CP-MVC-101-01

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04844073

Population:

Adult

Phase:

I/II

The purpose of this study is to determine the safety (how many side effects you and other patients have) and tolerability (how tolerable the side effects are) of a study drug called TAK186, and what is the highest and safest dose of TAK-186 that should be used for cancer patients. TAK-186 is a kind of antibody (a special kind of protein) being developed for the treatment of cancer. It is thought to work by attaching to both cancer cells and certain types of immune cells (T-cells) at the same time. TAK-186 is designed to activate T-cells to work against the cancer, helping the body’s...
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 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...
R4018-ONC-1721: A Phase 1/2 Study of REGN4018 (A MUC16xCD3 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...
Randomized Study of ONC-392 plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who Progressed on Androgen Receptor (AR) Pathway Inhibition

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05682443

Population:

Adult

Phase:

I/II

The main purpose of the study is to determine whether the study drug, ONC-392, together with a standard of care drug PLUVICTO® (Lutetium Lu 177 Vipivotide Tetraxetan), are safe and well tolerated, and whether two drugs are effective in treating prostate cancer, in comparison with the standard of care PLUVICTO® alone. ONC-392 has not yet been approved by the Food and Drug Administration (FDA). PLUVICTO® is FDA approved but is not approved to be combined with ONC-392. Are you Eligible? (Inclusion Criteria) Male 18 years or older -Confirmed prostate adenocarcinoma -Have had previous...
A Pilot Study of Neoadjuvant Combination Spartalizumab and Canakinumab Prior to Radical Nephrectomy in Patients with Localized Clear Cell Renal Cell Carcinoma (SPARC-1 Trial)

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT04028245

Population:

Adult

Phase:

I

The purpose of this study is to study two experimental drugs called canakinumab and spartalizumab produced by Novartis to see if: • It is safe and feasible to give canakinumab and spartalizumab prior to radical nephrectomy? • Canakinumab and spartalizumab can kill cancer cells and bring immune cells into the kidney cancer when hen given to human subjects prior to radical nephrectomy? You are being asked to participate in this study because you have localized kidney cancer and you are planned to have a radical nephrectomy. People who usually have this do not receive any additional...
A Phase 1 Study to Evaluate the Safety and Tolerability of AB680 Combination Therapy in Participants with Gastrointestinal Malignancies

Principal Investigator:

Gulam A. Manji, MD

Contact Number:

212-342-5162

NCT Number:

NCT04104672

Population:

Adult

Phase:

I

This study is being done to see if potential new drugs, AB680 and AB122, can be safely given in combination with chemotherapy to study patients with pancreatic cancer. The standard chemotherapy treatments that will be given in combination with AB680 and AB122 are nab-paclitaxel and gemcitabine. AB680 and AB122 are are not approved by the United States Food and Drug Administration (U.S. FDA). Are you Eligible? (Inclusion Criteria) Are you at least 18 years old? Do you have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma? Are you naïve to any prior treatment...
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...

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