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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) Inhibitor Combinations in Patients with RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06162221

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of an experimental drug called RMC-6291 or RMC-6236 in combination with pembrolizumab in non-small cell lung cancer (NSCLC). Both study drugs, RMC-6236 and RMC-6291, has not been approved by the Food and Drug Administration (FDA). Pembrolizumab is FDA approved but not in combination with RMC- 6291 or RMC-6236. You will be assigned to receive RMC-6291 in combination with pembrolizumab if you have an advanced cancer which has a mutation in a gene known as KRAS^G12C. You will be assigned to receive RMC-6236 in combination with pembrolizumab if you...
A Platform Study of RAS(ON) Inhibitors in Patients with Gastrointestinal Solid Tumors

Principal Investigator:

Gulam A. Manji, MD

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, MULTICENTER, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN (I-DXd), A B7-H3 ANTIBODY-DRUG CONJUGATE (ADC), IN COMBINATION WITH ATEZOLIZUMAB WITH OR WITHOUT CARBOPLATIN AS FIRST-LINE INDUCTION OR MAINTENANCE, IN SUBJECTS WITH EXTENSIVE-STAGE

Principal Investigator:

Lanyi Nora Chen, MD

Contact Number:

212-342-5162

NCT Number:

NCT06362252

Population:

Adult

Phase:

I/II

The purpose of this study is to learn more about an investigational drug, which is not approved by the United States Food and Drug Administration, called ifinatamab deruxtecan (I-DXd). It is being studied to see if it is safe and if your disease, extensive- stage small cell lung cancer (ES-SCLC), or other medical condition improves while taking it alongside other drugs, Atezolizumab, Carboplatin, and Etoposide. I-DXd is a type of drug called an antibody-drug conjugate, which is made up of 2 parts: an antibody and an anticancer drug. The antibody part binds to a protein commonly found on tumor...
An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety,Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 inPatients with Relapsed or Refractory Primary Central Nervous System Lymphoma

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT03328078

Population:

Adult

Phase:

I/II

This study is being done to test the orally administered study drug, CA-4948 in combination with ibrutinib in adult patients ages 18 and over diagnosed with relapsed or refractory (RR) Primary Central Nervous System Lymphoma (PCNSL). This study will take place at multiple centers globally. The study drug is thought to work by blocking a protein in your body called interleukin-1 receptor-associated kinase 4 (IRAK4). IRAK4 plays an essential role in some of the signaling pathways that are frequently not controlled in non-Hodgkin’s Lymphoma (NHL) and other hematological malignancies. When...
An Open-Label, Multicenter, Phase 1b/2 Study of RP1 in Solid Organ and Hematopoietic Cell Transplant Recipients with Advanced Cutaneous Malignancies

Principal Investigator:

Mariam El-Ashmawy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04349436

Population:

Adult

Phase:

I/II

This study is being done to find out how effective RP1 is in treating the cancer and how safe it is. These effects could be good (for example, shrinking of tumors) or bad (called side effects). Researchers will study the effects and how long they last. This study is being done to find out how effective RP1 is in treating the cancer and how safe it is. Are you Eligible? (Inclusion Criteria) Are you 18 or older? - Have either kidney, liver, heart, or lung transplant - No history of lung disease
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 to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients with Glioblastoma orNon-Small Cell Lung Cancer

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05256290

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug, BDTX-1535, which is not yet approved by the United States Food and Drug Administration (FDA), in treating patients with advanced solid tumors with changes in a protein named epidermal growth factor receptor (EGFR), which may or may not help your condition during this study. However, it may help other patients in the future. Are you Eligible? (Inclusion Criteria) Adults 18 years of age or older or as permitted by applicable local regulations at the time of providing informed consent. 2. Life...
A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients with Active Epidermal Growth Factor Receptor Mutation Locally Advanced or

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT05519293

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate the safety (the side effects) of H002, the study drug, and to determine the best dose of the drug to be given to patients. Another purpose is to find out the amount of study drug that is in your blood and how fast your body absorbs, metabolizes and eliminates the study drug from your body. This is the first study where H002 is being given to humans and it is not approved by the U.S. Food and Drug Administration (FDA). Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Must have life expectancy 3 months or more - Cannot have or major...
A Phase 1/2 Trial of Selinexor and Temozolomide in Recurrent Glioblastoma

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05432804

Population:

Adult

Phase:

I/II

This study is being done to answer the following question: How does selinexor given after temozolomide compare to temozolomide alone for lengthening the time that you can live with your brain cancer without it getting worse? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your brain cancer. The usual approach is defined as care most people get for brain cancer. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? 2) Have you been diagnosed with glioblastoma, and have previously been treated with...

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