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A Phase 1/2, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, andPreliminary Antitumor Activity of NDI-101150 Administered as Monotherapy or in Combination withPembrolizumab in Patients with Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05128487

Population:

Adult

Phase:

I/II

The purpose of this study is to find out if a new investigational drug NDI-101150 is safe when given alone and in combination with pembrolizumab, and to look at the pharmacokinetics (PK, to measure how your body takes up, breaks down, and clears NDI- 101150) and the antitumor activity (to measure how NDI-101150 works in your tumors). Investigational means the drug has not been approved by the Food and Drug Administration (FDA). This is the first time that NDI-101150 is being tested in humans. NDI-101150 is a small molecule inhibitor of HPK1 (a protein that weakens the immune system). It is...
A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04036682

Population:

Adult

Phase:

I/II

This is a research study evaluating a new investigational drug, called CLN-081. CLN-081 is a type of drug called a tyrosine kinase inhibitor. It targets a mutation in the tumor cell called EGFR exon 20 insertion with the goal to slow down or stop cancer cell growth. It is taken orally (by mouth). There are several different parts to this study, each with different study objectives, eligibility for entry and schedules of treatment. Participants at Columbia University Irving Medical Center may take part in either Module B Part 2 or Module C. If you are enrolled to Module B, part 2, the purpose...
A Phase 1/1b Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191(azercabtagene zapreleucel or“azer-cel”), in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT03666000

Population:

Adult

Phase:

I/II

The purpose of this research study is to obtain information on the safety and effectiveness of PBCAR0191 to treat certain types of cancers. PBCAR0191 is a new investigational treatment for certain types of cancer of the blood, such as leukemia and lymphoma. It is made from a type of blood cells known as T cells. The T cells in PBCAR0191 came from people who have donated their blood. The donated T cells have been genetically changed, so that they may be able to kill some types of cancer cells. Are you Eligible? (Inclusion Criteria) Must be 18 years of age or older Must have received at least 2...
A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination with Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT03604978

Population:

Adult

Phase:

I/II

Phase 2, Treatment A: This study is being done to see if your recurrent brain tumor may respond to a combination of radiosurgery (a type of radiation therapy) with nivolumab (a type of immunotherapy drug). A small number of patients have already received this combination previously and have tolerated the treatment relatively well. However, we would like to see if the combination treatment may be better or worse than the standard approach of radiosurgery alone. We would also want to learn more about the side effects associated with giving nivolumab with radiosurgery. Phase 2, Treatment B: This...
A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

Principal Investigator:

June Y. Hou, MD

Contact Number:

212-342-5162

NCT Number:

NCT03564340

Population:

Adult

Phase:

I/II

The main purpose of this study is to: • Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or in combination with cemiplimab to research subjects with ovarian cancer without too many side effects. • The study will also look at the levels of REGN4018 and/or cemiplimab in the body and measure how well your body can remove the study drug(s). This is called pharmacokinetics. • The study will also look at any signs that REGN4018 alone or with cemiplimab can treat cancer. Are you Eligible? (Inclusion Criteria) Do you have ovarian cancer? Are...
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Patients with Acute Leukemia and Other Selected Hematologic Malignancies, with and without Mixed Lineage Leukemia (MLL)-rearrangement or Nucleophosmin 1 (NPM1) Mutation

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT04988555

Population:

Adult

Phase:

I/II

You are being asked to participate in this study because you have acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or leukemia of mixed lineage (the leukemia cells cannot be classified as AML or ALL or where both types of AML and ALL cells are present). Because you have already received standard therapy that is no longer helping, or there is no standard of care for your type of leukemia at this point in your care, you are eligible to participate in a study such as this that involves an experimental drug. It is up to you and your study doctor to decide on whether to take part...
A Phase 1/2 study of IDE196 in patients with solid tumors harboring GNAQ/11 mutations or PRKC fusions

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT03947385

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety profile of IDE196 (an “investigational” drug), in enrolled subjects to find out if it is safe and possibly helpful in patients with certain cancers such as: metastatic uveal melanoma, cutaneous melanoma or colorectal cancer or cancers with mutations in genes called GNAQ, GNA11, or PRKC fusion. The study may last for approximately 25 months and your participation will depend on how well you tolerate the study drug and your overall condition during the study. Are you Eligible? (Inclusion Criteria) Do you have a solid tumor(s) that...
A Phase I/II, multi-center, open label study of DYP688 in patients with metastatic uveal melanoma (MUM) and other GNAQ/11 mutant melanomas

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT05415072

Population:

Adult

Phase:

I/II

The purpose of this study is to identify the most safe and tolerable dose of the study drug, DYP688 that can be given to patients. Also to evaluate how well DYP688 might work in treating certain types of cancer including the metastatic uveal melanoma and other melanomas with GNAQ/11 mutations (or genetic changes to the gene GNAQ/11). Metastatic means the disease has spread from an initial or primary site to a different areas of the body. DYP688 is a study treatment that has not been approved by the FDA. This study is the first time the study drug is being tested in humans. Are you Eligible? (...
A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants with Advanced or Metastatic Colorectal Cancer

Principal Investigator:

Yoanna S Pumpalova, MD

Contact Number:

212-342-5162

NCT Number:

NCT05379595

Population:

Adult

Phase:

I/II

The purpose of this study is to see if the study drug,amivantamab (also known as Rybrevant TM) is safe and useful for treating patients with Colorectal Cancer (CRC) when it is given alone or in addition to standard-of-care chemotherapies (mFOLFOX6 or FOLFIRI), as well as to find the best dose of amivantamab when given with chemotherapies. Amivantamab is an antibody made from a protein, designed to target and eliminate a specific harmful object in your body, in this case, a cancer cell. Amivantamab works by targeting a protein in your body known as epidermal growth factor receptor (EGFR), that...
A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination with Anti-cancer Agents in Patients with

Principal Investigator:

Maria Diaz Ordonez, MD

Contact Number:

212-342-5162

NCT Number:

NCT05417594

Population:

Adult

Phase:

I/II

The main purpose of this study is to determine a dose of AZD9574 that is safe and tolerable (does not cause side effects that could prevent people from taking the drug) when given alone or in combination with temozolomide. The study will also evaluate how much of the study drug is in your blood at various times. In addition, the action of the study drug will be evaluated by measuring specific chemicals in the blood. All parts of this study are experimental which means AZD9574 is not approved by the U.S. Food and Drug Administration (FDA). This is the first time AZD9574 has been tested in...

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