A PHASE IB STUDY TO ASSESS SAFETY OF CONCURRENT AZELIRAGON WITH CRANIOSPINAL IRRADIATION IN PATIENTS WITH LEPTOMENGINAL METASTASIS FROM SOLID TUMOR MALIGNANCIES OR HIGH-GRADE GLIOMAS
This study is a Phase 1b clinical trial at a single hospital to test the tolerability and safety of combining the drug Azeliragon with craniospinal irradiation (CSI) in patients with leptomeningeal metastasis from solid tumors or high grade gliomas. Patients will take Azeliragon for 7 days before starting CSI, continue it during CSI, and take it for 7 more days afterward. The study will test different doses to find the highest dose of Azeliragon that is tolerated with CSI, based on any issues during the first 4 weeks of treatment. Once the best dose is found, additional patients will be treated at that level. Patients will have regular check-ups, including brain and spine MRIs and spinal fluid tests, during treatment and at 4 weeks, 3 months, 6 months, 9 months, and 12 months after finishing CSI. The study will also track survival, disease progression, and patient-reported symptoms. Patients can continue other treatments, like chemotherapy or immunotherapy, after finishing radiation, and their progress will be followed until death
A Phase Ib/II Open-Label Multicenter Study Evaluating the Safety Activity And Pharmacokinetics of Divarasib in Combination with Other Anti-Cancer Therapies in Patients with Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer with a KRAS G12C Mutation
A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, And Pharmacokinetics of Divarasib in Combination with Other Anti-Cancer Therapies in Patients with Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer with a KRAS G12C Mutation
A Phase Ib/III Open-label Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced Unresectable or Metastatic Breast Cancer (CAPItello-292)
This is a Phase Ib/III, multicentre study of capivasertib plus CDK4/6i (palbociclib, ribociclib or abemaciclib) and fulvestrant, for the treatment of participants with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following either recurrence orprogression on, or after (neo)adjuvant ET. The study comprises two parts (Phase Ib and Phase III); the recommended Phase III doses (RP3Ds) of capivasertib and CDK4/6i in combination with a fixed dose of fulvestrant will be determined in the open-label, dose findingPhase Ib part. The efficacy and safety of the capivasertib arm will be compared to the control arm in the randomised, open-label Phase III part.The Phase Ib part of the study consists of an open-label, 3-arm dose finding phase to determine the safe and well tolerated doses and schedules (RP3D) of capivasertib plus CDK4/6i (palbociclib, ribociclib, or abemaciclib) and fulvestrant (the latter administered atfixed dose and schedule, as per label) as triplet combinations in participants with ABC. The maximum tolerated doses (MTD) may also be determined.The Phase III part is an open-label, randomised study assessing the efficacy of the capivasertib arm (capivasertib plus investigator’s choice of CDK4/6i [palbociclib or ribociclib] and fulvestrant) versus the control arm (investigator’s choice of CDK4/6i [palbociclib orribociclib] and fulvestrant) for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after endocrine therapy. The Phase III doses of capivasertib, palbociclib, and fulvestrantcombination and capivasertib, ribociclib, and fulvestrant combination were identified in the Phase Ib part of this study, based on the safety and tolerability data that were reviewed and endorsed by an external Safety Review Committee (SRC). Abemaciclib is not planned to beincluded among the Phase III CDK4/6i options due to an increasing global preference for ribociclib and the anticipated increasing use of abemaciclib in the adjuvant setting.
A Phase II 26-week double-blind placebo-controlled study to assess the safety tolerability pharmacokinetics and efficacy of ONO-2020 in patients with mild to moderate Alzheimer s Disease
This study will evaluate the safety and effectiveness of the drug ONO-2020 for mild to moderate Alzheimer's disease. The study will specifically investigate how safe the drug is, what side effects it causes, how well the body processes it, and how effective it is at improving Alzheimer's symptoms, such as memory loss.
A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
This study is designed to test a treatment called STK-012 for patients with advanced solid tumors. It is an open-label trial, meaning both the researchers and patients know what treatment is being given. The study has six parts: Phase 1a includes Part A, where STK-012 is given weekly, Part B, where it’s given every three weeks, Part C, where STK-012 is combined with another drug called pembrolizumab, and Part E, where it’s combined with pembrolizumab, pemetrexed, and carboplatin. Phase 1b includes Part D and Part F, which look at how effective these combinations are in a larger group of patients. The patients in the study have cancers that didn’t get better with standard treatments or can’t be treated with standard options. The study focuses on specific types of cancer, such as non-small cell lung cancer and kidney cancer. Each part of the study will carefully increase the doses to see how well the treatment works and to collect information about how it affects the body. There are also special groups to study how the treatment interacts with certain markers in the body.
A Phase II multicenter open-label trial of tagraxofusp (Tag) in combination with venetoclax and azacitidine (Ven/Aza) in adults with previously untreated CD123+ acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy
This study looks at how safe and effective a medicine called Tag is when combined with Ven and Aza for people with CD123+ acute myeloid leukemia (AML) who can’t have intense chemotherapy. The study has two parts. In Part 1, two doses of Tag (9 µg/kg/day and 12 µg/kg/day for three days) will be tested, along with the same doses of Ven and Aza. Patients will be randomly split into two groups to try one of the doses. Doctors will check for side effects, especially serious ones, to decide which dose is safest to use in Part 2. Patients in each group will be studied, and doses with too many side effects won’t be used. In Part 2, the safest dose will be tested to see how well it works using a method to predict how successful it might be. If it doesn’t seem to work, the study might stop early.
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).