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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...
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 Platform Study of RAS(ON) Inhibitors in Patients with Gastrointestinal Solid Tumors

Principal Investigator:

Gulam A. Manji, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT06445062

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of an experimental drug called RMC-6236 in combination with several chemotherapy medicines in patients with gastrointestinal cancers. The study will test the safety of RMC-6236 at different doses in combination with a fixed, standard dose of combination anti-cancer therapy, and how your body processes this combination. RMC-6236 is an investigational (experimental) drug, which means that it 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 -...
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 I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

Principal Investigator:

Nobuko Hijiya, MD

Contact Number:

212-342-5162

NCT Number:

NCT02332668

Population:

Pediatrics

Phase:

I/II

This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have either advanced melanoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL) or advanced, relapsed or refractory programmed cell death ligand 1 (PD-L1) positive malignant solid tumor or other lymphoma. Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D. This study is being sponsored by the Children's...
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,...

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