A Phase 1/2 open label first-in-human dose escalation and expansion study for the evaluation of safety pharmacokinetics pharmacodynamics and anti-tumor activity of SAR445877 administered as monotherapy or in combination with other anticancer therapies in adults with advanced solid tumors
This is an open-label, multi-center study testing whether the study medicine, SAR445877, (new fusion protein combining anti-programmed cell death 1 (PD1) antibody with modified interleukin (IL)15) is safe and has fewer side effects as a treatment alone or when given with other medicines for adult patients with solid tumors that have spread from their primary location. This study has two parts- For part 1, patients with solid tumors that have spread to other parts of their body and who have no alternative treatment options for their cancer will receive the study medicine every 2 weeks or weekly, together with other medicines decided by the study doctor. For part 2, patients will be divided into nine groups based on the type of their cancer. This group of patients will receive the study medicine at the dose that was found to be most effective and with fewer side effects in part 1 of the study, along with the medicine called cetuximab (EGFR antibody). All patients will have their blood samples taken to see how their bodies are handling the study medicine and to check if they are doing well. All patients will have special scans taken to see how the study medicine is changing their cancer. All patients will be closely monitored for safety and side effects.
A Phase 1/2 Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination with an anti-PD-1 Antibody in Patients with STK11-Mutated Advanced Solid Tumors
This is a first-in-human Phase 1/2, open-label, multicenter, dose-escalation and -expansionstudy designed to determine the MTD of TNG260 as single agent and in combination withpembrolizumab, to determine the RP2D(s) of the combination, and to evaluate the safety andtolerability, PK, and antineoplastic activity of escalating oral doses of TNG260 whenadministered alone and with a standard dose of pembrolizumab in participants with locallyadvanced or metastatic STK11-mutated solid tumors who have progressed on at least 1 lineof standard therapy or are ineligible for standard therapies.In Phase 1 (dose escalation), at least 3 DLT-evaluable participants will be enrolled insequentially escalating dose cohorts to determine the MTD of single agent TNG260, theMTD of the combination of TNG260 and pembrolizumab, and the RP2D(s) of TNG260 incombination with a standard dose of pembrolizumab. The dose escalation of TNG260 will beguided by two BLRMs based on any DLTs observed in the first cycle (ie, the first 21 days) ofthe single agent therapy and the second cycle for the combination therapy.Participants in Phase 2 (dose expansion) will be dosed at the RP2D(s) determined fromPhase 1 based on demonstrated tolerability, together with available PK data and results oftarget engagement studied during Phase 1 (or other measures including PD and efficacy), asapplicable. Three Phase 2 combination expansion arms (TNG260 in combination withpembrolizumab) will enroll up to approximately 30 participants each.
A Phase 3 Randomized Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician s Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)
This is a Phase 3 study testing whether the study medicine sacituzumab tirumotecan ( sac-TMT, antibody-drug conjugate (ADC) targeting TROP2), given alone or with pembrolizumab (immunotherapy), can treat triple-negative breast cancer (TNBC) in patients whose tumor shows little to no PD-L1 expression (CPS
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 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 II TRIAL EVALUATING THE SAFETY AND EFFICACY OF MR-LINAC- GUIDED RADIOTHERAPY AS SALVAGE TREATMENT AFTER EXTERNAL BEAM RADIOTHERAPY RECURRENCE (TUMORNATOR II)
This Phase 2 study is testing how using a special imaging technique called the Elekta Unity MR-linac system can be safe and effective for patients with prostate cancer that has not spread to other parts of the body after previous treatment with radiotherapy. Patients will have special scans taken before the study treatment to help the study team determine the treatment planning and doses. All patients will then be treated using an MR-guided approach on the Elekta Unity MR-linac system. The study team will collect tissue samples from all patients after treatment to see how the treatment is changing the tumor. All patients will have special scans taken and the study doctor will examine them to see how the patients are doing. All patients will be closely monitored for side effects and safety and followed every 6 months for up to 2 years after their treatment.
A Phase III Randomized Double-Blind Placebo-Controlled Multicenter Global Study of Rilvegostomig in Combination With Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer With Curative Intent (ARTEMIDE-Biliary01)
A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.
A PHASE III RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER STUDY TO EVALUATE THE EFFICACY SAFETY PHARMACOKINETICS AND PHARMACODYNAMICS OF SATRALIZUMAB AS MONOTHERAPY OR IN ADDITION TO BASELINE THERAPY IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (MOGAD)
This Phase III, randomized, double-blind (DB), placebo-controlled, multicenter study isdesigned to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics ofsatralizumab compared with placebo as monotherapy or in addition (add-on) tobaseline/background ISTs for MOGAD relapse prevention.The study will include a screening period of up to 28 days, an event-driven DB treatment period, and an approximately 2-year open-label extension (OLE) period.
A RANDOMIZED CONTROLLED TRIAL OF MAGNESIUM SULFATE AS AN ADJUNCTIVE ANALGESIC IN PROSTATE SURGERY
We will randomize prostate surgery patients to receive magnesium sulfate or not in the context of a standardized anesthetic. Postoperative pain scores and analgesic dose will be measured, in addition to the presence of shivering, quantitative neuromuscular blockade monitoring, drugs administered during anesthesia, and postoperative disposition (home or admission to hospital). We anticipate 110 subjects will give us 90% power to detect a 2 point difference in a 10 point pain score 30 minutes after awakening.