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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 1-2 dose-escalation and expansion study of ST101 in patients with advanced unresectable and metastatic solid tumors

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT04478279

Population:

Adult

Phase:

I/II

With this research study, we want to find out which dose of ST101 is tolerable and effective for people with different types of cancer. We also want to see what the body does to ST101, where ST101 goes in the body, and how long it stays in the body. This study is the first time we have given ST101 to humans. Drugs that can only be used in research are sometimes called 'investigational drugs.' Investigational means the study drug/formulation/medical device being tested is not approved by the U.S. Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Are you at least 18...
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT02693535

Population:

Adult

Phase:

II

Many research studies are done to try to find the best way to treat patients with cancer. Researchers are working on new anticancer agents that are targeted to the genes in a person’s tumor. Genes are the basic “instruction book” for the cells that make up our bodies and are made out of DNA. DNA contains information that determines things such as eye and hair color. DNA is made up of long strands of repeating letters that form a code. The order of these letters in DNA is important. In the same way that a spelling mistake in a word could change its meaning (for example, mean...
Phase 1b/2 Study of ATR InhibiTor RP-3500 and PARP Inhibitor Combinations in Patients with Molecularly Selected Cancers (ATTACC)

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT04972110

Population:

Adult

Phase:

I/II

The study is being done to learn how safe and effective the study drug, RP- 3500, is when given with either niraparib or olaparib to treat advanced cancer. Niraparib and olaparib belong to a group of drugs called PARP inhibitors. These drugs are designed to block an enzyme called PARP which may stop cancer cells from growing. RP 3500 belongs to a class of drugs called ATR inhibitors that are design to stop cancer cells from growing. Are you Eligible? (Inclusion Criteria) Aged 18 years or older. Diagnosed with locally advanced or metastatic cancer. Have not received prior therapy with another...
First-in-Human, Phase 1/1b, Open-label, Multicenter Study ofBifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapyand in Combination Therapy in Patients with EGFR-DrivenAdvanced Solid Tumors

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04429542

Population:

Adult

Phase:

I

This is a first-in-human clinical research study. This study is sponsored by a biopharmaceutical company named Bicara Therapeutics. The main purpose of this study is to investigate the study drug BCA101 alone and BCA101 in combination with pembrolizumab for its safety, the way the body absorbs, distributes, and gets rid of this study drug, how the study drug acts on the body, and whether it works on your cancer in patients with advanced cancer like you. Subjects will receive either BCA101 alone or BCA101 in combination with pembrolizumab until disease worsens, the subject stops benefitting...
A Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)

Principal Investigator:

Dawn L Hershman, MD, MS, FASCO

Contact Number:

212-342-5162

NCT Number:

NCT04960787

Population:

Adult

Phase:

NA

Studies have shown that cancer patients and their spouses may be at high risk for financial problems because of the cost of cancer treatment. This study is being done to answer the following question: Can a financial navigation program help patients and their spouses understand and better manage the financial aspects of cancer care? A financial navigator is a person or team who work with patients and their families to help them reduce stress or hardship related to the cost of cancer treatment. Financial navigators help patients understand their out-of-pocket expenses and what their health...
A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients with Advanced Solid Malignancies and Lymphoma with an Expansion in Select Malignancies

Principal Investigator:

June Y. Hou, MD

Contact Number:

212-342-5162

NCT Number:

NCT02922764

Population:

Adult

Phase:

I

The main purpose of this study is learn about the the safety and side effects of the study drug, RGX-104. RGX-104 is an experimental drug. This means that RGX-104 is not approved by the Food and Drug Administration (FDA). This is the first time RGX-104 will be given to humans. Are you Eligible? (Inclusion Criteria) Do you have a confirmed solid tumor? Have you had treatment for your disease before? Or is there not a standard treatment available for your disease? Does your cancer continue to grow? Can your cancer not be removed by surgery? Are you 18 years of age or older?
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...
Trial of a Smartphone Application to Improve Medication Adherence among Patients with Cancer

Principal Investigator:

Melissa Accordino, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

NA

The purpose of this study is to learn about the difficulties patients have with the amount of medication they are required to take and to see if a smart phone application can make that process easier for patients. Patients will be asked to use an application on their smartphone or tablet daily and to come to the clinic once a month for 3 months. Are you Eligible? (Inclusion Criteria) Do you have advanced or metastatic cancer, or a hematologic malignancy? Are you taking, or planning to take at least one oral anti-cancer drug? Do you have access to a mobile phone or tablet that can download...
A PHASE 1 OPEN-LABEL STUDY OF HER3-DXd (PATRITUMAB DERUXTECAN; U3-1402) IN COMBINATION WITH OSIMERTINIB IN SUBJECTS WITH LOCALLY ADVANCED OR METASTATIC EGFR-MUTATED NON-SMALL CELL LUNG CANCER (NSCLC) (HER3-DXd [PATRITUMAB DERUXTECAN; U3-1402] IN

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04676477

Population:

Adult

Phase:

I

The purpose of this study is to determine the combination dose of patritumab deruxtecan and osimertinib that can be given to patients safely and to understand how well patritumab deruxtecan alone or in combination with osimertinib works to treat lung cancer. Osimertinib is an EGFR TKI therapy that targets EGFR mutations. Osimertinib has already been approved by several regulatory authorities for the treatment of patients with advanced non-small cell lung cancer whose tumors contain specific EGFR mutations. This will be the first time patritumab deruxtecan is used in combination with...

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