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An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants with Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT04794699

Population:

Adult

Phase:

I

IDE397 is an investigational drug, which has not been approved by health authorities for the treatment of people with your medical condition. It is currently not “on the market” (available for you to receive a prescription for and/or to buy) in any country. In this study, different dose levels of IDE397 will be tested. About 40 patients are expected to participate at approximately 6-8 study centers within the US. At a minimum, 2 patients will be enrolled in each dose level. There will be about 10 dose levels tested (starting at 5 mg). Every time a dose level is found to be safe, a...
A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04898634

Population:

Adult

Phase:

I

You are being invited to take part in a research study that includes studying JNJ-78278343 in subjects with prostate cancer. This is an investigational drug which means that this is a new approach for the treatment of people who have prostate cancer. The main purpose of this study is to find a safe dose of JNJ- 78278343 that can be used in the treatment of prostate cancer. To do this, we must find out if JNJ-78278343 can cause side-effects. Also, we need to find out how long JNJ-78278343 stays in and acts on your body and how your body responds to it. Prostate cancer is known to have high...
A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 as a Single Agent and in Combination Therapy in Subjects with Selected Advanced Solid Tumors

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05098132

Population:

Adult

Phase:

I

The main purpose of this study is to determine the highest dose of STK-012 that can be given safely alone and in combination with a standard dose of pembrolizumab in subjects with advanced solid tumors, this will be assessed in the dose escalation phase of the study. In the dose expansion phase of the study, the highest dose of STK-012 that can be safely given in combination with pembrolizumab, as determined in the dose escalation phase, will be given to more people for further study.STK-012 is a modified (changed in the laboratory) form of a cytokine (protein) called interleukin-2 (IL-2)...
A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, in Patients with Advanced Solid Tumors and Lymphomas

Principal Investigator:

Hua-Jay J Cherng, MD

Contact Number:

212-342-5162

NCT Number:

NCT05279300

Population:

Adult

Phase:

I

This is a study of the experimental drug CS5001 developed by CStone pharmaceutical, in patients with advanced hematological and solid tumors. CS5001 will target certain receptors that are in high levels on cancer cells. This study will look at the anti-tumor activity of CS5001. CS5001 is not approved by any regulatory agency for the treatment of any condition. It is only available in clinical studies such as this one. To date, it has only been tested in animal studies. This is the first time that the study drug will be given to humans. Are you Eligible? (Inclusion Criteria) Are you at least...
A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034 (balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT03860272

Population:

Adult

Phase:

I

This research study mainly aims to test the safety and tolerability of AGEN1181 and balstilimab and to determine the most appropriate dose of the study drug AGEN1181 alone and in combination with balstilimab. AGEN1181 targets cells that are a part of the body’s immune system to block a protein called cytotoxic T- lymphocyte associated protein-4 (CTLA-4). Balstilimab can specially block a protein called programmed-death 1 (PD-1) and prevent communication between this protein and receptors on the tumor-cells. These receptors are known to affect the body’s defense mechanism to...
A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05216432

Population:

Adult

Phase:

I

This research study is designed to learn about the safety of an experimental (investigational) drug called RLY-2608, also called the study drug, when given to individuals who have been diagnosed with metastatic (spread to other areas of the body) or unresectable (cannot be removed surgically) cancers and have at least one mutation in a gene called PIK3CA. “Investigational” means that it is not yet known if this drug helps patients, has not been approved by the Food and Drug Administration (FDA) or any other regulatory agency, and is not available for sale as a marketed product...
A Controlled Multi-Arm Phase 1 Umbrella Study Evaluating the Safety and Feasibility of T-Cell Receptor Engineered Donor T-Cells Targeting HA-1 (TSC-100) or HA-2 (TSC-101) in HLA-A*02:01 Positive Patients Undergoing Haploidentical Allogeneic Peripheral

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT05473910

Population:

Adult

Phase:

I

The study involves research of two study drugs (TSC 100 and TSC 101), given in combination with the standard of care (SOC). The purpose of the study is to see if TSC 100 and TSC 101 are safe and effective in treating your blood cancer. The study also is measuring the effect of these study drugs on your immune system (immunogenicity of study drugs). TSC 100 and TSC-101 are experimental new study drugs that have not yet been approved by the US Food and Drug Administration (FDA) or regulatory authorities in any other countries. This is a first-in-human study, which means that these study drugs...
A Phase 1 Study of Lenalidomide in Combination with EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL)

Principal Investigator:

Jennifer Effie Amengual, MD

Contact Number:

212-342-5162

NCT Number:

NCT04301076

Population:

Adult

Phase:

I

Are you 18 years of age or older? Have you been diagnosed with human T-cell leukemia virus (HTLV)-associated adult T-cell leukemia-lymphoma (ATLL)? Are you able to make regularly scheduled visits to the clinic for treatment and examinations? Are you Eligible? (Inclusion Criteria) The purpose of this study is to test the safety and tolerability (side effects) of adding a study drug called lenalidomide at different doses in combination with the usual treatment with EPOCH chemotherapy. “Dose” is defined as the amount of drug a patient gets, such as 15 mg. These drugs have already...
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...

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