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A Phase 1 Study of ASP3082 in Participants with Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies with KRAS G12D Mutation

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05382559

Population:

Adult

Phase:

I

The purpose of this study is to find out if ASP3082 is effective and safe as a treatment in advanced cancers with KRAS G12D mutation. ASP3082 may work by directing proteins found in your body to block the growth of cancer cells. This is the first study where ASP3082 is being tested in humans. Are you Eligible? (Inclusion Criteria) Are you 18 years or older? Do you have locally advanced/unresectable or metastatic solid tumor with documented KRAS G12D mutation? Have you never been treated with another specific KRAS G12D inhibitor?
A Phase 1, Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®819 in Subjects with Relapsed or Refractory Clear Cell Renal Cell Carcinoma

Principal Investigator:

Karie Danielle Keera Runcie, MD

Contact Number:

212-342-5162

NCT Number:

NCT05433142

Population:

Adult

Phase:

I

The purpose of this study is to assess whether an investigational drug called XmAb819 has any effects on Clear Cell Renal Cell Carcinoma, to determine if it is safe and well tolerated, and to determine the dosing schedule. The investigational drug will be given by intravenous (IV – into the vein) infusion over a 2 hour period. This study will also see how the body affects the study drug and how much study drug is in the blood (pharmacokinetics, or “PK”), how the drug affects the tumor and body (pharmacodynamics, or “PD”), and if the body develops antibodies...
A Multicenter Open-Label Study of RMC-6236 in Patients with Advanced Solid Tumors Harboring Specific Mutations in KRAS

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05379985

Population:

Pediatrics/Adult

Phase:

I

The purpose of this study is to test an experimental drug called RMC-6236 (the study drug) for solid tumor cancer with a KRAS mutation. The KRAS protein sends signals that cause cancer cells to grow. RMC-6236 is designed to prevent the KRAS protein from sending these signals, and this blocking action may slow or stop the growth of your cancer cells. RMC-6236 is an experimental drug, which means that it is 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-6236 will be tested in humans. The safety of...
A Phase 1, First-in-Human, Dose-Finding and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of XmAb®808 in Combination with Pembrolizumab in Selected Advanced Solid Tumors

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT05585034

Population:

Adult

Phase:

I

The purpose of this study is to assess whether an investigational drug, called XmAb808, given in combination with pembrolizumab, has any effects on your cancer, to determine the best dose of XmAb808 to treat your cancer, and if it is safe and well tolerated. XmAb808 is an investigational drug being developed for the treatment of advanced solid tumors. An investigational drug is a drug that has not been approved by the U.S. Food and Drug Administration (FDA), the health authority that approves new medicines to be prescribed in the United States. Are you Eligible? (Inclusion Criteria) Subject...
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 Study of PARG Inhibitor IDE161 in Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05787587

Population:

Adult

Phase:

I

The purpose of this study is to find out if the experimental study drug called IDE161 used alone is safe and helpful in solid tumors known to be caused by an error in genes that repair DNA. Cells have different ways to repair damaged DNA. Experimental means that the study drug has not been approved by any regulatory authorities, including the U.S. Food and Drug Administration (FDA) .IDE161 may block the ability of a protein called Poly(ADP-ribose) glycohydrolase (PARG) from properly functioning. PARG is an important protein in a different DNA repair pathway called Base Excision Repair (BER)...
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-...

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