Phase 1/2 Study of PARG Inhibitor ETX-19477 in Patients with Advanced Solid Malignancies
This study is designed to test how the drug moves through the body (pharmacokinetics), how it works (pharmacodynamics), and how well it fights tumors. The drug being tested is ETX-19477, which targets a specific protein in cancer cells. The study has two parts: Phase 1 will test different doses of the drug to find the dose with the least amount of side effects that works, and Phase 2 will look at how well that dose works for treating cancer. In Phase 1, patients will be given different amounts of the drug to see which dose is best tolerated, starting with small doses and increasing them if it’s safe. Researchers will keep track of patients’ health and any side effects, and check how well the drug helps shrink the tumors. The goal is to find the best dose and learn how well ETX-19477 works against advanced cancers.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with estrogen receptor-positive (ER+) human epidermal growth factor receptor 2 (HER2)-negative locally advanced and unresectable or metastatic breast cancer expressing somatostatin receptors (SSTRs) and progressed after antibody-drugconjugates and/or chemotherapy (TRACY-1)
This is a phase 1b/2 study testing whether the study medicine RYZ101 (targeted radiopharmaceutical therapy) will be a safe and better option for treating patients with ER+, HER2-negative breast cancer. This study will be done in two parts. In the first part, patients will be sequentially enrolled and divided into groups to receive study medicine at different dose levels. The study team will find out the dose that works well and has fewer side effects. In the second part of the study, more patients will be included to receive the study medicine that was effective and had fewer side effects for patients in the first part. All patients will have blood samples taken to see how their bodies are handling the study medicine. Special scans will be taken for all patients to see how the study medicine is changing their cancer. The study team will monitor all patients for side effects and safety.
Phase 2/3 Multistage Multicenter Randomized Double-Blind Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The purpose of this study is to see if nipocalimab is safe and useful for treating participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This is the first study where nipocalimab is being administered to participants with CIDP.
Phase 3 Accelerated BEP Trial: A randomised phase 3 trial of accelerated versus standard BEP chemotherapy for patients with intermediate and poor-risk metastatic germ cell tumours
The primary purpose of the study is to determine if accelerated BEP (Bleomycin, Etoposide, cisPlatin) is effective and tolerable for patients with advanced gem cell tumor compared to the standard treatment. We want to know if the accelerated chemotherapy using the same drugs is beneficial but not more toxic than the standard chemotherapy regimen. The accelerated chemotherapy is experimental.
Phase 3 Randomized Open-label Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan in Combination with Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants with Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)
This is a Phase 3 trial testing whether the study medicine sacituzumab tirumotecan (an antibody-drug conjugate, also known as sac-TMT, or MK-2870), when given in combination with another medicine called pembrolizumab (an immunotherapy medicine), is effective and a better treatment in patients with a specific type of endometrial cancer called proficient (pMMR) endometrial cancer. This trial will compare treatment with sac-TMT plus pembrolizumab to pembrolizumab alone. This study has two parts- Part 1 is the Induction phase, where patients will receive pembrolizumab and chemotherapy, and Part 2 is the Maintenance phase, where patients whose cancer has not progressed, as shown by the CT scans, will be divided into two groups to receive either sac-TMT plus pembrolizumab or pembrolizumab alone. Patients will undergo CT scans during the study to see how their cancer is changing in response to the study treatment. Blood samples will be taken from all patients to see how their bodies are handling the study medicine. All patients will be closely monitored for any side effects and safety concerns.
Phase I open-label trial evaluating BI 1810631 as monotherapy in the treatment of patients with advanced or metastatic solid tumors with HER2 aberrations (BEAMION-Lung 1)
This is a Phase I, open-label, multicentre trial of BI 1810631 administered orally as a singleagent. The trial has two parts; Phase Ia, which is the dose escalation part (non-randomised),and Phase Ib which is the dose expansion part. The dose expansion part will consist of 3cohorts. If needed, the expansion part will include a randomised dose optimization in Cohort1
Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2/CDK Pathway Mutations
This is a phase 2 study testing how well the study medicines vismodegib (a Hedgehog pathway inhibitor), GSK2256098 (a selective focal adhesion kinase (FAK) inhibitor), and capivasertib (an ATK kinase inhibitor) work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). All patients will have genetic testing done before entering the study to check for changes in their tumor genes (mutations). One treatment group of this trial (the capivasertib arm) remains open to enrollment for patients at NYU. The study team will find out if patients receiving the study medicine live longer overall and how long it takes for their cancer to spread and get worse. Blood samples will be collected from all patients to see how their bodies are handling the study medicine. Special scans will be done for all patients to see how the study medicines are changing their cancer. All patients will be closely monitored for side effects and safety concerns and will be followed up for up to 5 years after registration in the study.
PHASE II: ADAPTIVE TREATMENT DE-ESCALATION IN FAVORABLE RISK HPV-POSITIVE OROPHARYNGEAL CARCINOMA
This will be a phase II single-arm clinical trial. The primary objective of this study is to evaluate progression-free survival at 2 years.The secondary objectives will include 2-year locoregional control and overall survival, quality of life, and late toxicity. Quality of life outcomes can be assessed with a validated, self-reported questionnaire. Late toxicity can be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events. Additionally, the prognostic value of positive HPV in salivary rinse as well as plasma at mid and post- treatment time points will be evaluated with a baseline evaluation pre-treatment. Radiomic analysis of pre-treatment imaging will be correlated with outcomes.
Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) For Intact Brain Metastases
This phase III trial compares the effectiveness of fractionated stereotactic radiosurgery (FSRS) to usual care stereotactic radiosurgery (SRS) in treating patients with cancer that has spread from where it first started to the brain. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. FSRS delivers a high dose of radiation to the tumor over 3 treatments. SRS is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. FSRS may be more effective compared to SRS in treating patients with cancer that has spread to the brain.
Phenotypic and genotypic study of Keratoconus
Keratoconus is a disease in which the cornea is abnormally steep and thin. It affects approximately 1 in 2000 individuals and usually begins in the second decade of life. Keratoconus is a progressive disorder which results in loss of vision that cannot be alleviated by contact lenses or glasses alone, and is a leading indication for corneal transplantation in developed countries (Udar et al., IOVS 47: 3445-3351, 2006). Keratoconus has a strong genetic component, and while several genes are suspected clear causative genes and underlying pathogenic processes have not been identified yet. We will enroll isolated keratoconus and familial cases and unaffected members of the families when available. The goal of our research is to identify genes that harbor mutations that contribute to keratoconus and underlying biochemical processes that are altered as a result and contribute to keratoconus pathogenesis. The subject population consists of individuals diagnosed with keratoconus and unaffected relatives in families. Individuals/families are ascertained through support groups, web-based listings of research studies and genetic testing services, and a keratoconus research website that Dr. Chakravarti and other team members maintain. The identities of the study participants will be known only to Dr. Chakravarti, the study coordinator, physicians in the team and the post-doctoral fellow(s) working directly on the project.DNA, lymphocytes, and lymphoblastoid cell lines may be prepared from the blood samples for future use. Molecular analysis using markers and sequencing, and statistical analysis of these data, will be used to identify regions of human chromosomes where putative keratoconus disease genes reside. Analyses of DNA sequences of all coding region of genes from keratoconus subjects compared to published control subjects DNA will be performed to identify disease specific variants. Additionally to understand disease pathogenesis, subsets of patients may be asked to provide tear samples or impression cytology of their conjunctiva (a thin tissue paper is placed under the eyelid area and lifted off which brings small number of patient cells that can be visualized by histology). Study subjects will not directly benefit from participation; the purpose of the study is to better understand the etiology of keratoconus, leading to improved detection, treatment, and management. Results will not be disclosed to participants nor their health care providers, unless medically relevant.