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A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy ofLY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing TumorCells, in Participants with Selected Advanced Solid Tumors

Principal Investigator:

Lanyi Nora Chen, MD

Contact Number:

212-342-5162

NCT Number:

NCT07046923

Population:

Adult

Phase:

I

The purpose of this study is to learn about the effects of the study drug, LY4175408, to find the best dose for treating advanced/metastatic (meaning the cancer has spread beyond where it started to other parts of the body) cancers and to see how safe LY4175408 is for patients with advanced/metastatic cancers. LY4175408 is an “investigational” drug in this study because it has not been approved by The United States Food and Drug Administration (FDA), the health authority that gives approval for new medicines in the United States. Are you Eligible? (Inclusion Criteria) Is ≥18...
A Phase 1 study of JNJ-95437446 in adult participants with advanced-stage solid tumors

Principal Investigator:

Lanyi Nora Chen, MD

Contact Number:

212-342-5162

NCT Number:

NCT07107230

Population:

Adult

Phase:

I

The purpose of this study is to investigate if the study drug JNJ-95437446 is safe and effective in treating patients with advanced-stage non-small cell lung cancer, colorectal cancer, and head and neck squamous cell cancer. This study will also find out if JNJ-95437446 can cause side effects. Side effects are unexpected or unwanted reactions from taking a drug. Another purpose is to find out how long JNJ-95437446 stays in your body and how your body responds to it. Are you Eligible? (Inclusion Criteria) Must be 18 years of age or older - Must be diagnosed with metastatic non-small cell lung...
A Phase 1 Study of PF-08046040/SEA-CD70 in MyeloidMalignancies

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT04227847

Population:

Adult

Phase:

I

You are being asked to participate in this study because you have Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) and we are testing the study drug’s, SEA-CD70, to find out what its side effects are and to see if the study drug is safe for people with these types of cancer. are testing to see if SEA- CD70 is safe for people, and its side effects. SEA-CD70 is a type of drug called an antibody. Antibodies are part of your immune system. Usually they help protect you from getting sick. The purpose of this study is to use study drug SEA-CD70, and while using another antibody...
A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 asMonotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT07277413

Population:

Adult

Phase:

I

The purpose of this study is to determine the ideal dose of the study drugs, IDE892 by itself and IDE892 in combination with IDE397, and to find out what effect, good and/or bad, these study drugs may have on your cancer. This will be first human study for IDE892. Both IDE892 and IDE397 has not been approved by the United States (US) Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Must be willing and able to provide blood/tumor tissue samples for biomarker testing - Must be able to swallow and retain the study drug
CD5-deleted chimeric antigen receptor cells (Senza5 CART5) to enhance immunotherapy against Tcell non-Hodgkin lymphoma (NHL): a first-in-human phase I clinical trial

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT06420089

Population:

Adult

Phase:

I

The purpose of this study is to test whether Senza5 CART5 is safe to give to participants with T-cell non-Hodgkin lymphoma (NHL). The study will also test how Senza5 CART5 cells affect your cancer and how long they survive in your body. It will take some of your white blood cells, called T cells, and modify them with the hopes that they target the cancer cells or cells that help the cancer to grow. The change involves adding or altering the genes in your T cells, which are part of your immune system. The modified cell product given in this study is called Senza5 CART5. Senza5 CART5 is...
CHRONIC CONVECTION ENHANCED DELIVERY OF TOPOTECAN FOR RECURRENT MALIGNANT GLIOMA

Principal Investigator:

Jeffrey N Bruce, MD

Contact Number:

212-342-5162

NCT Number:

NCT06666712

Population:

Adult

Phase:

I

The purpose of this study is to determine the safety of directly injecting a chemotherapy drug called Topotecan and a contrast agent called Gadolinium into malignant brain tumors. Currently there is no effective treatment for recurrent malignant brain tumors, which means the brain tumor has returned after the original tumor has been treated. Most systemic chemotherapy drugs have toxic side effects, which make them difficult to use for brain tumors. However, we are doing this study to find out if using an experimental method of directly infusing the drug into the tumor, allows research...
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 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...
FORAGER-1: A Phase 1, Open-Label, Multicenter Studyof LOXO-435 (LY3866288) in Locally Advanced orMetastatic Solid Tumors Including Urothelial Cancer withFGFR3 Alterations

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT05614739

Population:

Adult

Phase:

I

You are being asked to participate in this study because you have cancer that is late in stage or spread to other parts of the body that includes the lining of urinary tract. The purpose of this study is to see whether LY3866288 is safe, the possible side effects, how well your disease responds to treatment study drug and which does level of study drug should be tested and is the most optimal for patients in future studies along with Pembrolizumab and Enfortumab Vedotin. LY3866288 is an investigational study drug which mean it is not approved by the United States Food and Drug Administration...
NOVA-BCL6-1, A First-in-Human, Multicenter Phase 1a/1b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants with Previously Treated Hematologic Malignancies

Principal Investigator:

Barbara Pro, MD

Contact Number:

212-342-5162

NCT Number:

NCT07226843

Population:

Adult

Phase:

I

The purpose of this study is to determine the safety at different dose levels, tolerance, and possible side effects of LY4584180, alone and in combination with another anticancer therapy (drug named rituximab), in participants with lymphoma. LY4584180 has not been approved by the Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Cannot be part of another study at the same time - Must have life expectancy greater than 2 years
Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection with ex vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells

Principal Investigator:

Pawel Muranski, MD

Contact Number:

212-342-5162

NCT Number:

NCT05183490

Population:

Adult

Phase:

I

The purpose of this study is to test whether giving an experimental cell product can treat viral infection in patients who have conditions that cause the poor function of their immune system. The patients with infections caused by viruses such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK and JC polyomaviruses (PyVs) virus may participate in this study. The cell product is called rapidly generated virus-specific T cells (R-MVST). R-MVST cells will be manufactured in our laboratory at Columbia University Irving Medical Center. This cell product has not been approved...

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