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UVADEX® (methoxsalen) Sterile Solution in conjunction with the THERAKOS® CELLEX Photopheresis System as an interventional therapy for the treatment of CTCL (Mycosis Fungoides) in patients with TMN classification stage IA, IB or IIA, an open-label,

Principal Investigator:

Larisa J Geskin, MD

Contact Number:

212-342-5162

NCT Number:

NCT05680558

Population:

Adult

Phase:

II

To assess the efficacy of the UVAR® THERAKOS® CELLEX Photopheresis System to treat early stage (IA, IB or IIA) cutaneous T-cell lymphoma (CTCL) using the modified skin-weighted assessment tool (mSWAT) to determine overall response. Are you Eligible? (Inclusion Criteria) This study will include patients who have the diagnosis of Mycosis Fungoides (including confirmatory biopsy) and are over the age of 18. Patients must have the appropriate staging (IA, IB or IIA) and be refractory to at least one of the standard therapies used to treat Mycosis Fungoides. Patients must not be on any...
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 I/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti tumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT05914116

Population:

Adult

Phase:

I/II

DB-1311 (study drug) is an investigational antibody-drug conjugate (antibody that guides the study drug to cancer cells) composed of an anti-B7-H3 (a protein associated with worse overall survival and drug resistance) antibody and P1021 (slows DNA replication in cancer cells). Investigational means the study drug being tested is not approved by the United States (U.S.) Food and Drug Administration (FDA). The main goal of this study is to test whether the study drug is safe and tolerable in patients with certain types of cancer. This study will also measure the amount of the study drug in...
A Phase 1b/2 Study Evaluating the Activity of Tinengotinib (TT–00420) in Combination with Androgen Receptor Signaling Inhibitors (ARSIs) in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06457919

Population:

Adult

Phase:

I/II

You are being asked to take part in this study because you have a type of prostate cancer called metastatic castration-resistant prostate cancer (mCRPC), meaning that your disease has spread to other parts of your body (metastatic). The purpose of this study is to determine whether adding the experimental drug tinengotinib, which is not yet approved by the United States Food and Drug Administration (FDA), to your standard treatment is safe, effective, and produces minimal or mild side effects in individuals with mCRPC. Additionally, we will evaluate the effectiveness of tinengotinib in...
A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination with Pembrolizumab orStandard Therapies Including Chemotherapy and/or Immunotherapy in Participants with LocallyAdvanced or Metastatic Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05083481

Population:

Adult

Phase:

I/II

The purpose of this study is to determine at what dose the study treatment (ASP1570) by itself or in combination with Pembrolizumab infusion therapy or standard therapies is safe and tolerated in study participants with locally advanced or metastatic solid tumors that cannot be removed or have spread (metastasized) to other parts of the body. The Food and Drug Administration (FDA) in the United States has not approved ASP1570 for the treatment of any form of cancer. This is a first in human study and all of the risks of the study drug are not fully known yet. Are you Eligible? (Inclusion...
A Phase I/II Open Label Study to Evaluate the Safety, Cellular Kinetics, and Efficacy of AZD0754, aChimeric Antigen Receptor (CAR) T-cell Therapy Directed Against STEAP2, in Adult Participantswith Metastatic Prostate Cancer: APOLLO

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT06267729

Population:

Adult

Phase:

I/II

The purpose of this study whether AZD0754 is safe to administer to people with prostate cancer that has spread to other parts of your body (metastatic) and whether it can help to treat their type of cancer. AZD0754 is a type of study treatment called chimeric antigen receptor or CAR T-cell therapy. It uses cells from the subject's own immune system, called T-cells, to attack cancer cells. AZD0754 has not been approved by the Food and Drug Administration (FDA). This is a first in human study. A few days before AZD0754 infusion, the subject will have chemotherapy to lower the number of white...
A PHASE 1/2 STUDY OF REGN5678 (ANTI-PSMAXCD28) WITH OR WITHOUT CEMIPLIMAB (ANTI-PD-1) IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER AND OTHER TUMORS ASSOCIATED WITH PSMA EXPRESSION

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT03972657

Population:

Adult

Phase:

I/II

The purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness of REGN5678 which will be given alone first and then be given in combination with cemiplimab. Neither REGN5678 nor Cemiplimab is FDA approved to treat your type of cancer. Cemiplimab is approved by the FDA for the treatment of certain types of metastatic cutaneous squamous cell carcinoma (CSCC) (one of the main types of skin cancer ) or locally advanced CSCC (who are not candidates for curative surgery or curative radiation). REGN5678 has not yet been studied in people. Are...
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...
An open-label, multicenter, dose escalation and expansion phase 1/2 study to evaluatethe safety, tolerability and pharmacokinetics, and anti-tumor activity of GI-102, a CD80-IgG4Fc-IL-2v bispecific fusion protein, as a single agent and in combination with

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT05824975

Population:

Adult

Phase:

I/II

This study will see if the study drug, GI-102, alone or in combination with conventional anti- cancer drugs, pembrolizumab or trastuzumab deruxtecan, has an effect on the tumor and whether it causes any side effects. This study is to test study drugs in people with all types of solid tumors (certain tumor types for some groups). Pembrolizumab, which is approved in the USA and some other countries, is available by prescription to treat several different cancers, but is not approved to treat all types of cancer in this study. GI-102 is still experimental and is not approved by any regulatory...

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