A Phase II multisite open-label single arm trial of BNT327 in combination with docetaxel in second-line stage IV non-small cell lung cancer (NSCLC) following chemoimmunotherapy
This is a phase 2 study testing a new medicine, BNT327 (an investigational antibody), together with another medicine called docetaxel (standard chemotherapy treatment) to find the dose that works well and with fewer side effects for patients with advanced lung cancer that has spread to other parts of the body and who have received standard chemotherapy treatment before. This study has two parts. In the first part, the study team will find out the most effective dose of the combination of BNT327 and docetaxel that is safe and has fewer side effects. In the second part, more patients will be included to get the most effective dose found in the first part of the study. All patients will have their blood samples taken to see how the body is handling the study medicine and how the medicine changes the tumor. Patients will have special scans taken at different time points. Doctors will evaluate all the results to learn how medicine changes the tumor and make sure the patients are doing well. The study team will closely watch all patients for side effects and follow up to 90 days after their last dose.
A PHASE II OPEN-LABEL MULTI-COHORT MULTICENTER STUDY IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA AND CHILD-PUGH B7 AND B8 CIRRHOSIS
This is a Phase II, open-label, multicohort, multicenter study in patients with unresectable, locally advanced, or metastatic HCC who have Child-Pugh B7 or B8 liver cirrhosis who have received no prior systemic therapy in this treatment setting. The study is designed to non-comparatively evaluate the safety and efficacy of atezolizumab plus bevacizumab or atezolizumab monotherapy in this population.
A phase II randomized double-blind placebo-controlled multi-center study to assess the safety tolerability and preliminary efficacy of empagliflozin among patients with residual kidney function receiving hemodialysis for the treatment of end-stage kidney disease
This study is a randomized, 12-week pilot trial to investigate biologic efficacy and safety of empagliflozin in End Stage Kidney Disease (ESKD) patients on maintenance hemodialysis (HD). This pilot trial (via PAS-20-160) will provide critical data to inform the design of a larger multi-center study.
A Phase II Randomized Double-Blind Placebo-Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis
The purpose of this study is to evaluate the effect and safety of the treatment Ensifentrine on the occurrence of pulmonary exacerbations and on patient-reported symptoms in subjects with non-cystic fibrosis bronchiectasis (NCFBE).
A Phase II randomized open-label multi-center study of JSB462 (luxdegalutamide) in combination with abiraterone in adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC)
This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with mHSPC and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated.
A Phase II randomized open-label multi-center study of JSB462 (luxdegalutamide) in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with mCRPC with prior exposure to at least 1 ARPI and 0-2 taxane regimens and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated.
A PHASE II RANDOMIZED OPEN LABEL MULTI-CENTER STUDY OF THE EFFECTS OF ELCTRONIC CIGARETTES ON SMOKING HARM REDUCTION IN CIGARETTE SMOKERS WITH SERIOUS MENTAL ILLNESS.
This study will compare the feasibility and preliminary efficacy of telehealth motivational counseling + e-cigarettes versus telehealth motivational counseling + combination Nicotine replacement therapy (NRT; patch and lozenge) on reduction of cigarettes per day (CPD) and health outcomes among smokers diagnosed with Serious Mental Illness (SMI).
A Phase II Single-Arm Study of Craniospinal Irradiation with Linac Based Volumetric Modulated Arc Therapy (VMAT) for Patients with Leptomeningeal Metastasis
This study is a non-randomized phase II single-institution trial in which patients who consent to the trial will be treated with linac based VMAT CSI. The primary objective is to determine if linac based VMAT CSI for leptomeningeal metastases improves CNS progression free survival compared to historical control treated with IFRT. The investigators include doctors with expertise in treating leptomeningeal metastases both with radiation and systemic therapy.
A Phase II Study of DRP-104 a glutamine antagonist in patients with NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer and Gastroesophageal Cancer
This is a Phase 2 study testing a new medicine called DRP-104 (a glutamine antagonist) in patients with non-small cell lung cancer (NSCLC). These patients have changes or mutations in genes called NFE2L2 orKEAP1 and this makes their cancer harder to treat with chemotherapy and immunotherapy.The medicine DRP-104 works by blocking something called glutamine, which the cancer cells need to grow. This study will use a two step process to see if the medicine works well in the first group, before allowing other patients to join. In step one, patients will be given DRP-104 two times a week with at least three days betweeneach treatment, with no rest period between cycles (continuous schedule). If the results are promising and show this medicine is shrinking the tumors or stopping them from growing, more patients will be added in step two tocontinue testing the drug. All patients will have frequent medical check ups and blood samples taken to see how their bodies are handling the study medicine. The study team will have special scans done for all patients to see how the cancer isresponding to the study medicines. The study team will be monitoring the patients for potential side effects and safety concerns.
A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients with Muscle-Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations
This is a study that looks at whether it's safe to treat patients with bladder cancer who have certain gene changes (called DDR gene alterations) in their tumor. These patients have had a procedurecalled TURBT (a way to remove part of the tumor) before treatment. They will get chemotherapy with gemcitabine and cisplatin. The study will check if the treatment works well by looking at how many patients are still cancer-free three years after they start treatment. If more than 80% of the patients are cancer-free at that time, the treatment will be considered safe. The patients will also be watched for five years to see how many stay cancer-free. If patients' tumors do not have these gene changes, or if the tumor shrinks but not enough, they will have their bladder removed (called cystectomy) and will be followed for five years to see if the cancercomes back or if they survive longer. If patients who could have had bladder-preserving treatment end up having their bladder removed, they will also be watched for five years to see how they do.