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Showing 1 - 10 of 12 Trials

A Randomized, Phase 3, Open-label Study of Neoadjuvant Darovasertib in Subjects with Primary Non-metastatic Uveal Melanoma (OptimUM-10)

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT07015190

Population:

Adult

Phase:

III

The study drug used in this study is darovasertib. The study drug will be given to you orally (by mouth) if you participate in the study. You should only take the study drug as instructed. Darovasertib is an investigational (experimental) new drug, which means darovasertib has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authorities in the world. Darovasertib blocks a protein in your body called Protein Kinase C (PKC). Approximately 90% of people with uveal melanoma have a genetic mutation in PKC. The tumor may depend on the effects of PKC to...
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB1305 inParticipants with Advanced/Metastatic Solid Tumors

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT06953089

Population:

Adult

Phase:

II

The purpose of this study is to test whether combining two investigational study drugs, DB-1311 with BNT327 or DB-1311 with DB-1305, is safe and can be tolerated by participants with advanced or metastatic solid tumors. The study will also test how much of the study drugs are in the blood at different times, if the body makes antibodies against the study drugs, and how the study drugs affect the disease. Additionally, the study may also explore how certain molecules in the blood or tissue (biomarkers) relate to the drug's effects. DB-1311, BNT327, and DB-1305 are investigational drugs,...
A Phase 1, First-in-Human, multicenter, open-label trial ofDS9051b in participants with advanced or metastaticadrenocortical carcinoma (ACC) and metastatic castrationresistantprostate cancer (mCRPC)

Principal Investigator:

Alexander Z. Wei, MD

Contact Number:

212-342-5162

NCT Number:

NCT07189403

Population:

Adult

Phase:

I

he purpose of this trial is to learn more about an investigational drug called DS9051b. DS9051b is an investigational drug that is not Food and Drug Administration (FDA) approved for your disease. This is a first in human study. It is being studied to see if it is safe, and if your disease improves while taking it. Are you Eligible? (Inclusion Criteria) Must be 18 years old or older - Must be able to swallow the study drug - Must not have known gastrointestinal disease or procedure that may interfere with absorption of the study drug
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 First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy ofLY4175408, an Antibody Drug Conjugate Targeting Protein Tyrosine Kinase 7-Expressing TumorCells, in Participants with Selected Advanced Solid Tumors

Principal Investigator:

Lanyi Nora Chen, MD

Contact Number:

212-342-5162

NCT Number:

NCT07046923

Population:

Adult

Phase:

I

The purpose of this study is to learn about the effects of the study drug, LY4175408, to find the best dose for treating advanced/metastatic (meaning the cancer has spread beyond where it started to other parts of the body) cancers and to see how safe LY4175408 is for patients with advanced/metastatic cancers. LY4175408 is an “investigational” drug in this study because it has not been approved by The United States Food and Drug Administration (FDA), the health authority that gives approval for new medicines in the United States. Are you Eligible? (Inclusion Criteria) Is ≥18...
Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A PilotStudy

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT06673329

Population:

Adult

Phase:

I

The purpose of this study is to test the safety and effectiveness of using brodalumab in patients who develop side effects from cancer immune therapy. Immune-related side effects are due to activation of the immune system in patients who previously received immunotherapy and the goal of this study is to help better control these side effects. Brodalumab is often used to treat patients with autoimmune diseases (diseases where the immune system is activated against normal organs) and safe doses and treatment schedules have been determined in these patients. Immune-related side effects appear to...
Phase 1b/2, Multicenter, Open-label, Dose Escalation and DoseExpansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients with Advanced KRAS G12C-Mutated Solid Tumors

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06128551

Population:

Adult

Phase:

I/II

The purpose of this study is to test a combination of 2 new drugs called RMC-6291 and RMC 6236 (the study drugs). RMC-6291 and RMC-6236 are new investigational (ie, experimental) drugs, which means that they are not approved by the United States (US) Food and Drug Administration (FDA) or any other health authorities. This is the first study in which RMC 6291 and RMC-6236 will be tested together in humans. This study will test the safety and anti-tumor effects of RMC-6291 and RMC-6236 when given together at different doses in participants with a change or alteration in the KRASG12C gene within...
A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Efficacy of YL217 in Patients with Advanced Solid Tumors

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT06859762

Population:

Adult

Phase:

I

The main purpose of this study is to evaluate the safety and effectiveness of the study drug, YL217, in different solid tumor types. We also want to learn: ● The dosage of YL217 that can be safely given to humans ● What effect (good or bad) YL217 has on your cancer ● What happens to YL217 once it is in your body (so called pharmacokinetics; PK) ● What YL217 does to your body MediLink Therapeutics has begun a study of an investigational drug (also known as the “study drug”) called YL217 as a possible treatment for CDH17 expressed solid tumors. CDH17 is a type of protein found on...
First-in-Human, Phase 1/1b, Open-label, Multicenter Study ofBifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapyand in Combination Therapy in Patients with EGFR-DrivenAdvanced Solid Tumors

Principal Investigator:

Catherine Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04429542

Population:

Adult

Phase:

I

This is a first-in-human clinical research study. This study is sponsored by a biopharmaceutical company named Bicara Therapeutics. The main purpose of this study is to investigate the study drug BCA101 alone, BCA101 in combination with pembrolizumab, or BCA101 in combintaion with encorafenib for its safety, the way the body absorbs, distributes, and gets rid of this study drug, how the study drug acts on the body, and whether it works on your cancer in patients with advanced cancer like you. Subjects will receive either BCA101 alone, BCA101 in combination with pembrolizumab, or BCA101 in...
Phase 1, open label single-arm two-part study to investigate safety, pharmacokinetics, andpreliminary efficacy of pan-RAF/MEK glue NST-628 oral tablets in subjects with solid tumorsharboring genetic alterations in the MAPK pathway and with other solid

Principal Investigator:

Benjamin Izar, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT06326411

Population:

Adult

Phase:

I

The purpose of this study is to find out if, and at what dose, NST-628 can safely treat solid cancers in patients who have no other treatment options left. NST-628 has been tested in animals and demonstrated some anti-tumor activity. This research study will be the first in which it will be given to humans and is experimental. “Experimental” means that the study drug has not been approved by any government authority responsible for the regulation of new medicines. This trial will explore what doses of NST-628 are safe and tolerable, as well as see whether NST-628 can slow the...

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