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RINGSIDE: A Phase 2/3, Randomized, Multicenter Study toEvaluate AL102 in Patients with Progressing Desmoid Tumors

Principal Investigator:

Prabhjot Singh Mundi, MD

Contact Number:

212-342-5162

NCT Number:

NCT04871282

Population:

Adult

Phase:

II/III

You are being asked to participate in this study because you have been diagnosed with a progressive desmoid tumor. The purpose of this study is to see if the study drug, called AL102 (referred to from now on as the “study drug”), is safe and effective in people with progressive desmoid tumors. The study will also look at how your body responds to the study drug and how your body processes the drug . The study drug works by stopping a chemical pathway in the cells that allows desmoid tumors to grow. It is hoped that by stopping this pathway the study drug will stop desmoid tumor...
A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination with AGEN2034 (balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects with Advanced Cancer

Principal Investigator:

Brian Henick, MD

Contact Number:

212-342-5162

NCT Number:

NCT03860272

Population:

Adult

Phase:

I

This research study mainly aims to test the safety and tolerability of AGEN1181 and balstilimab and to determine the most appropriate dose of the study drug AGEN1181 alone and in combination with balstilimab. AGEN1181 targets cells that are a part of the body’s immune system to block a protein called cytotoxic T- lymphocyte associated protein-4 (CTLA-4). Balstilimab can specially block a protein called programmed-death 1 (PD-1) and prevent communication between this protein and receptors on the tumor-cells. These receptors are known to affect the body’s defense mechanism to...
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...
A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT04068194

Population:

Adult

Phase:

I/II

This study is being done to answer the following question: Is M3814 in combination with radiation therapy and avelumab safe and tolerable in patients with advanced or metastatic cancers. We are doing this study because we want to find out if this approach is better or worse than the usual approach for your advanced or metastatic cancer. The usual approach is defined as care most people get for advanced or metastatic solid tumor. Are you Eligible? (Inclusion Criteria) Are you 18 years of age or older? Do you have a tumor which has spread to other parts of your body or that has advanced and...
LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of [177Lu]Lu-FAP-2286 in Patients with an Advanced Solid Tumor

Principal Investigator:

Ryan H. Moy, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT04939610

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of the experimental drugs called 68Ga-FAP-2286 and 177Lu-FAP-2286. 8Ga-FAP-2286 is an imaging agent that targets a certain protein which has been found in certain tumors called Fibroblast activation protein (FAP). Imaging using 68Ga-FAP-2286 will determine if participants are eligible to receive the experimental radiotherapy, 177Lu-FAP-2286, which researchers think may kill cancer cells by delivering radiation to cancer cells that have fibroblast activation protein (FAP). Are you Eligible? (Inclusion Criteria) Have you been diagnosed with...
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 Randomized Trial Addressing Cancer-Related Financial Hardship Through Delivery of a Proactive Financial Navigation Intervention (CREDIT)

Principal Investigator:

Dawn L Hershman, MD, MS, FASCO

Contact Number:

212-342-5162

NCT Number:

NCT04960787

Population:

Adult

Phase:

NA

Studies have shown that cancer patients and their spouses may be at high risk for financial problems because of the cost of cancer treatment. This study is being done to answer the following question: Can a financial navigation program help patients and their spouses understand and better manage the financial aspects of cancer care? A financial navigator is a person or team who work with patients and their families to help them reduce stress or hardship related to the cost of cancer treatment. Financial navigators help patients understand their out-of-pocket expenses and what their health...
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...

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