A Phase 3 Randomized Placebo-Controlled Double-Blind Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients with P53 Wild-Type Advanced or Recurrent Endometrial Carcinoma (GOG 3083)
The purpose of this research study is to further evaluate the safety and effectiveness of selinexor for maintenance in patients with TP53 wild-type endometrial cancer.
A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC Lenalidomide and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy.
This is a phase 3 study to test medicines named Teclistamab (Tec-DR) and Talquetamabin (Tal-DR) together with standard treatment called Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in patients who are newly diagnosed with blood cancer and are ineligible or not intended to get Stem Cell Transplant as the first treatment. Patients will be grouped to receive either Tec-DR, Tal-DR or DRd drugs. All patients will have blood samples taken to see how well patient's body is handling this treatment. Doctors will closely monitor patients who has received the study medicines for any side effects, to see if these medicines are safe and well tolerated, examine the results of blood work, do the vital sign measurements and physical examination. The patients will be followed up to 30 days (+7 days) after the last dose of study treatment or before the start of a new treatment, whichever comes first.
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
The purpose of this study is to learn about the safety, effectiveness, and long-term outcomes of the research drug, pegozafermin, for patients with compensated cirrhosis due to MASH when compared to a placebo.
A Phase 3 Superiority Study Comparing the Safety and Efficacy of SNP-ACTH (1-39) Gel compared to Rituximab and FDA approved biosimilars in Adults with Primary Membranous Nephropathy (PMN) in a Two-Phase Adaptive Trial Design
This trial is recruiting individuals with Primary Membranous Nephropathy (PMN) - a kidney-specific, autoimmune disease in which your body's defense system turns against you and harms your body. PMN presents with increased protein in the urine. Currently, rituximab is recommended to treat PMN. In this study, SNP-ACTH (1-39) Gel will be evaluated as the study drug because other synthetic ACTH (Adrenocorticotropic hormone) therapies had been shown to be efficacious in PMN treatment as ACTH is suggested to directly protect kidneys (more specifically, podocytes of the kidneys) while modulating the over-active immune system of the body. The active ingredient of the study drug is an ACTH hormone that’s similar to the ACTH hormone in the body, but it’s synthesized in a laboratory and combined with gelatin (of porcine origin) for a more sustained release formulation. Cerium Pharmaceuticals, Inc. is funding this research study. The overall trial is divided into two Phases: Phase 3a (this ICF applies to the 3a only) Phase 3b (a separate ICF will be provided for the 3b) The purpose of this overall research study is: For Phase 3a: To determine the optimum dose of SNP-ACTH (1-39) Gel in subjects with PMN. For Phase 3b: To test the safety and effectiveness of SNP-ACTH (1-39) Gel relative to rituximab in subjects with PMN. SNP-ACTH (1-39) Gel of Cerium Pharmaceuticals, Inc. is a study drug product. It has not been approved by the United States Food and Drug Administration (FDA) for marketing in the USA for the treatment of PMN. Other long-acting ACTH therapies are used in the USA or other countries for the treatment of PMN. Currently, rituximab therapy is suggested as a starting treatment for reduction of the activation of the immune system against the body for high risk PMN subjects.
A Phase 3 Two-stage Randomized Multi-center Controlled Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM)
This is a two-stage, Phase 3, randomized, multi-center, controlled, open-label study comparing iberdomide maintenance to lenalidomide maintenance therapy after ASCT in participants with newly diagnosed multiple myeloma.The primary objective of this study is to compare the efficacy of iberdomide to that of lenalidomide maintenance after ASCT in participants with NDMM, as measured by PFS.
A PHASE I FIRST-IN-HUMAN OPEN-LABELTRIALTO INVESTIGATE THE SAFETY TOLERABILITY PHARMACOKINETICS AND PRELIMINARY ANTITUMOR ACTIVITY OF SIM0500 A HUMANIZE GPRC5D-BCMA-CD3 TRISPECIFIC ANTIBODY IN PARTICIPANTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA
This is a clinical trial that aims to test the effectiveness and how the body processes a drug called SIM0500 in adult patients with relapsed or refractory multiple myeloma (RRMM). The trial has two parts: Part 1 focuses on finding the right doses (dose escalation), and Part 2 looks at optimizing those doses. In both parts, patients will receive SIM0500 until their disease worsens, they experience severe side effects, they decide to stop, or the trial ends. In Part 1, researchers will start with a low dose of 0.15 µg/kg and may lower it to 0.05 µg/kg if patients have serious side effects. The treatment will be given once a week, and each treatment cycle will last 28 days.
A Phase I Multicenter Open-label First-in Human Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Tumors
This is a first-in-human modular Phase 1, open-label, multi-center study to evaluate the safety and tolerability and identify a recommended phase 2 dose (RP2D) of AZD9592 alone and with a specific combination treatment, in EGFR and cMET expressing tumors, initially NSCLC EGFR mut (L858R/ex19del) and wild type, as well as HNSCC. The study will also evaluate the preliminary efficacy, PK, PD and immunogenicity of AZD9592.
A phase I open-label multi-center study of KFA115 as a single agent and in combination with pembrolizumab in patients with select advanced cancers
This study is a FIH, open-label, phase I, multi-center study that consists of two treatment arms in dose escalation: single-agent KFA115 (Arm A escalation) and KFA115 in combination with pembrolizumab preceded by a KFA115 run-in for 1 cycle (Arm B escalation). In expansion, the study consists of three treatment arms: single-agent KFA115 (Arm A expansion), KFA115 in combination with pembrolizumab after single-agent KFA115 run-in (Arm B expansion), and KFA115 to be initiated with pembrolizumab concurrently (Arm C expansion).
A PHASE I RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED SINGLE-CENTER STUDY OF SAFETY AND EFFECTIVENESS OF INNATE IMMUNITY STIMULATION VIA TLR9 IN MILD COGNITIVE IMPAIRMENT OR EARLY AD
This single-center, double-blind, placebo-controlled study will recruit in total 39 participants with either Mild Cognitive Impairment due to Alzheimer’s disease (MCI) or Mild Alzheimer’s disease dementia (mild AD). There will be 3 Dose levels. An initial cohort of 13 subjects will be randomized to a Dose level 1 (0.1 mg/kg vs. placebo) lasting 8 weeks. An additional 13 subjects will be recruited and randomized into Dose level 2 (0.25 mg/kg vs. placebo) for 8 weeks and 13 subjects for the last Dose level 3 (0.5 mg/kg vs. placebo) for 8 weeks. Primary ObjectivesEvaluate the safety and tolerability of 3 escalating dose levels of CpG 1018 (dose level 1: 0.1 mg/kg vs. placebo; dose level 2: 0.25 mg/kg vs. placebo; dose level 3: 0.5 mg/kg vs. placebo) as 3 subcutaneous (s.c.) injections in patients with MCI or mild AD.Secondary ObjectivesKey secondary objectives:• To evaluate drug effect on immunostimulatory responses• To evaluate drug effect on disease progression An independent unblinded Data Safety Monitoring Board (DSMB) will convene at regular intervals to monitor the overall safety of the study and to make recommendations to the PI related to study safety as appropriate.
A PHASE I/IB SINGLE ARM STUDY OF TWO FRACTION SBRT WITH DOMINANT LESION SIB FOR THE TREATMENT OF LOCALIZED PROSTATE CANCER
Phase I/IB, single arm trial of Two-Fraction SBRT with an MRI directed, dominant intraprostatic lesion, simultaneous integrated boost based on genomic classification in the treatment of localized prostate cancer. Primary endpoint will be physician-reported grade 2 or higher CTCAE toxicity. Secondary endpoints are: EPIC quality of life, PSA Nadir, and Phoenix Definition Biochemical failures as well as Disease Free Survival, Overall Survival, and MFS.