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A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05973487

Population:

Adult

Phase:

I

The purpose of the study is to learn if the study treatments TSC-204-A0201, TSC 200- A020, and TSC-204-C0702 alone or in combination, referred to as T-Plex, are safe and effective in treating your type of cancer. T-Plex has not yet been approved by the Food and Drug Administration (FDA). This is a first-in-human study, which means that these products have never been administered to humans before. You are unlikely to benefit from taking part in this study. Are you Eligible? (Inclusion Criteria) Must be 18 years or older - Diagnosed with a locally advanced (unresectable) or metastatic solid...
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 1/1b Study of ASP2138 as Monotherapy and in Combination with Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05365581

Population:

Adult

Phase:

I

The goal of this study is to see if a study drug called ASP2138 is safe and effective for people diagnosed with tumors known to have Claudin (CLDN) 18.2 expression. CLDN is a group of proteins seen in gastric-specific, gastroesophageal junction (GEJ) or pancreatic cancer types. The study will also see how ASP2138 is processed in the blood. Each participant will complete a number of procedures and blood collections in order to find the best dose of ASP2138. When this dosage is identified, it will be used to evaluate if ASP2138 causes tumors to shrink. ASP2138 will be assessed continuously...
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-...
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety and Preliminary Efficacy of BMS-986393 in Novel Combinations in Participants with Relapsed and/or RefractoryMultiple Myeloma and Determine the Recommended Dose for Each Add-on Investigational

Principal Investigator:

Divaya Bhutani, MD

Contact Number:

212-342-5162

NCT Number:

NCT06121843

Population:

Adult

Phase:

I

The purpose of this study is to test whether BMS-986393 in combination with other anti- cancer drugs is safe and effective at treating people with multiple myeloma (MM) that has come back after previous treatment (relapsed) or is not responding to current treatment (refractory). The researchers think that the combinations of alnuctamab, mezigdomide, or iberdomide with BMS-986393 in people with relapsed/refractory MM may improve their disease or keep their disease under control. This is an open-label, multicenter study that will recruit potential participants in the United States (USA) and...
An Open-Label Phase 1b Study Evaluating the Safety and Efficacy of Etentamig (ABBV-383) in AL Amyloidosis

Principal Investigator:

Rajshekhar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT06158854

Population:

Adult

Phase:

I

The purpose of this study is to see how safe and effective is the study drug, ABBV-383. ABBV-383 works by binding to a specific protein called B-cell maturation antigen, which is found on the surface of cells affected by amyloidosis. By engaging T-cells, a type of white blood cell, ABBV-383 helps activate the immune response to target and remove the abnormal proteins that cause amyloidosis. The study drug ABBV-383, is not approved by the U.S Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years or older - Must consent to fresh pretreatment bone marrow...
A Phase 1 Study of SGN-B6A in Advanced Solid Tumors

Principal Investigator:

Lanyi Nora Chen, MD

Contact Number:

212-342-5162

NCT Number:

NCT04389632

Population:

Adult

Phase:

I

The purpose of this study is to study SGN-B6A alone, with pembrolizumab, or with pembrolizumab and one of the chemotherapy drugs (cisplatin or carboplatin). The sponsor wants to find out what its side effects are and if it works for specific types of cancer. It is not yet know if SGN-B6A alone or with other drugs is better or worse than other treatments. This clinical trial uses an experimental drug. This means the Food and Drug Administration (FDA) hasn’t approved it for sale in the United States. This drug is called SGN-B6A. This clinical trial also uses pembrolizumab. The brand name...
A Phase 1a/1b Study of LY4052031, an Antibody-Drug ConjugateTargeting Nectin-4, in Participants with Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT06465069

Population:

Adult

Phase:

I

The purpose of this study is to determine whether using LY4052031 in a type of cancer that may have tumor cells that express a protein called Nectin-4 is safe and how well the cancer responds to the study drug. LY4052031 has not been approved by the US Food and Drug Administration (FDA). This is a first in human study and all of the risks are not fully known yet. Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Life expectancy must be more than 12 weeks - Must not have uncontrolled diabetes
A MULTICENTER, OPEN-LABEL PHASE 1/1B DOSE-FINDING, SAFETY, AND PHARMACOKINETIC STUDY OF MBRC-101, AN ANTI-EPHA5 MONOMETHYL AURISTATIN E(MMAE) ANTIBODY DRUG CONJUGATE, IN ADVANCED REFRACTORY SOLID TUMORS

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06014658

Population:

Adult

Phase:

I

The purpose of this research is to determine the dose and dosing regimens of an investigational drug, MBRC-101, that are well tolerated, as well as to evaluate its safety in patients with advanced or metastatic solid tumors that have already received conventional therapy. MBRC-101 is not an approved treatment anywhere in the world. “Investigational” means that the drug has not been approved by any government authority responsible for the regulation of new medicines, such as the U.S. Food and Drug Administration (FDA). This is the first time MBRC-101 is being tested in humans. Are...

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