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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 and BCA101 in combination with pembrolizumab 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 or BCA101 in combination with pembrolizumab until disease worsens, the subject stops benefitting...
A Phase 1a/1b Study of the PI3Ka:RAS Breaker BBO-10203 in Subjects with Advanced SolidTumors (The BREAKER-101 Trial)

Principal Investigator:

Linda Y. Wu, MD

Contact Number:

212-342-5162

NCT Number:

NCT06625775

Population:

Adult

Phase:

I

The purpose of this study is to find the best dose and effects of BBO-10203 when used alone or in combination with Trastuzumab in HER2-positive advanced breast cancer (aBC) or HR- positive, HER2-negative aBC or advanced non-small cell lung cancer (aNSCLC) with a KRAS (Kirsten rat sarcoma) mutation or advanced colorectal cancer (aCRC) with a KRAS mutation.BBO-10203 has not been approved by the Food and Drug Administration (FDA). Trastuzumab is FDA approved but not in combination with BBO-10203. This is a first in human study. Are you Eligible? (Inclusion Criteria) Must be 18 years old or older...
A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB VERSUS SOTORASIB OR ADAGRASIB IN PATIENTS WITH PREVIOUSLY TREATED KRAS G12C-POSITIVE ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Principal Investigator:

Benjamin Herzberg, MD

Contact Number:

212-342-5162

NCT Number:

NCT06497556

Population:

Adult

Phase:

III

The purpose of this study is to evaluate how well and how safely the experimental drug, divarasib, works compared to other approved drugs for people with advanced or metastatic non-small cell lung cancer (NSCLC) that has a mutation in the kirsten rat sarcoma virus (KRAS) G12C gene. This gene mutation drives cancer growth. The other approved treatments are sotorasib or adagrasib. The study drug, divarasib, is experimental, meaning it has not yet been approved by the U.S. Food and Drug Administration. While several drugs targeting this gene mutation have recently been developed, there is still...
Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination with Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients with Untreated NPM1 Mutated or KMT2A Rearranged

Principal Investigator:

Joseph G. Jurcic, MD

Contact Number:

212-342-5162

NCT Number:

NCT07007312

Phase:

III

The purpose of this study is to evaluate an investigational drug called ziftomenib when added to either non-intensive chemotherapy (venetoclax and azacitidine) or intensive chemotherapy (cytarabine and daunorubicin), followed by ziftomenib maintenance therapy. Investigational means that ziftomenib has not been approved by the Food and Drug Administration (FDA) for use outside of research studies. Maintenance therapy refers to ongoing treatment given after the initial therapy to help keep the cancer from returning. Ziftomenib is being studied as a possible treatment for acute myeloid leukemia...

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