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A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants with Advanced Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04895709

Population:

Adult

Phase:

I/II

The main purpose of this study is to test the safety of the investigational drug, BMS-986340, administered alone and in combination with nivolumab. This study will investigate how patients with selected advanced solid tumors tolerate these drugs to identify the highest tolerable dose or the most suitable dose, explore any changes in your tumor, and your general health after receiving multiple doses of BMS-986340 alone or together with nivolumab. BMS-986340 is an immunotherapy antibody and an investigational research drug. Investigational drugs are drugs that are not yet approved by the Food...
A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04851119

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find out what dose of tegavivint should be used with children and how well it works when given to patients between the ages of 12 months to 30 years of age with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas, osteosarcomas, liver tumors (HCC and hepatoblastoma), Wilm's tumor and tumors with Wnt pathway aberrations. Tegavivint is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of children with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas,...
A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT04870944

Population:

Pediatrics/Adult

Phase:

I/II

The purpose of this study is to find the highest dose of CBL0137 that can be given safely to patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory) solid tumors, including the CNS tumors and lymphoma. CBL0137 will be given into a vein on Day 1 and Day 8 of a 21 day cycle for up to 17 cycles, which will last about 24 months. Are you Eligible? (Inclusion Criteria) Inclusion Criteria: Part A: Patients must be at least 1 year of age and 21 years of age, have been diagnosed with relapsed or refractory relapsed or refractory solid tumors or lymphoma...
A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients with Advanced Solid Tumors

Principal Investigator:

Julia E McGuinness, MD

Contact Number:

212-342-5162

NCT Number:

NCT05252416

Population:

Adult

Phase:

I/II

This first-in-human study will evaluate the recommended dose, safety, and effects (good and bad) of an experimental drug, BLU-222, either alone or in combination with therapies approved for some types of cancer, including carboplatin, ribociclib, and fulvestrant, to find out if these are safe and effective ways to treat nonresectable (unable to be removed with surgery) advanced solid tumors, including ovarian, endometrial, and estrogen receptor positive (ER+) or human epidermal growth factor receptor 2 negative (HER2-) breast cancer. All subjects participating in this research study will...
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...
An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis

Principal Investigator:

Rajshekar Chakraborty, MD

Contact Number:

212-342-5162

NCT Number:

NCT05451771

Population:

Adult

Phase:

I/II

The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in subjects with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis. Furthermore, the purpose of phase 2 part of this study is to compare the effectiveness of venetoclax and dexamethasone versus investigator’s choice treatment in this condition. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Can you comply with the procedures in this study, which include taking the study drug and extra clinic...
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, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT04623541

Population:

Adult

Phase:

I/II

The purpose of this study is to investigate the safety and tolerability of the study drug, epcoritamab, as a treatment for Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome. This means the study will look into the potential side effects of epcoritamab and how well it works against your disease. This study will also measure epcoritamab levels in your blood and how long epcoritamab stays in your body. Are you Eligible? (Inclusion Criteria) • Must be at least 18 years of age • Women can not be pregnant • Male and Women of child bearing potential must agree to...
A Phase 1/2, Open-Label, Dose-Escalationand -Expansion Study of the Bruton TyrosineKinase-Targeted Protein-Degrader BGB-16673 inPatients With B-Cell Malignancies

Principal Investigator:

Nicole Lamanna, MD

Contact Number:

212-342-5162

NCT Number:

NCT05006716

Population:

Pediatrics

Phase:

I/II

The purpose of this study is to look at the safety and tolerability of the study drug, BGB- 16673. Another purpose is to determine the range of BGB-16673 doses that can safely be used. BGB-16673 is an experimental drug. This means that it has not been approved for treatment by the US, the Food and Drug Administration (FDA). This research study is the first time that BGB-16673 will be given to humans and therefore the effects of BGB-16673 on humans are not yet known Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Must have life expectancy more than 6 months - Must be...
A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF ORAL MRT-2359 IN PATIENTS WITH MYC-DRIVEN AND OTHER SELECTED SOLID TUMORS INCLUDING LUNG CANCER AND DIFFUSE LARGE B-CELL LYMPHOMA

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT05546268

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety and confirm the best dose in humans for an investigational drug called MRT-2359 in subjects with solid tumors and diffuse large B-cell lymphoma. “Investigational” means the study drug has not been approved for the treatment of participants with cancer by the Food and Drug Administration (“FDA”) or any other health/regulatory authority anywhere in the world.MRT-2359 is called a molecular glue degrader or MGD. This MGD can selectively stick to a protein called G1 To S Phase Transition 1 (GSPT1) and cause GSPT1 to...

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