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 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.
A Phase I/IIa Dose Escalation Study Evaluating the Safety Tolerability and Preliminary Efficacy of Intraductal Administration of RXRG001 to Parotid Gland(s) in Adults with Radiation-Induced Xerostomia and Hyposalivation
This is a Phase 1/2a study testing whether administering the new study medicine RXRG001 (a lipid nanoparticle containing circular mRNA) directly into the ducts of the parotid glands (salivary glands) is a safe and effective treatment for patients with radiation-induced dry mouth (xerostomia) and reduced saliva production (hyposalivation). This study has two parts. In Part 1 of the study, patients will be divided into two groups. Patients in Group 1 will be subdivided into three groups - each group will receive a single dose of study medicine at three different dose levels. Patients in Group 2 will also be subdivided into three groups to receive three monthly doses of the study medicine at three different dose levels. In Part 2 of the study, patients will be randomly assigned to 3 groups. Each group of patients will receive multiple doses of study medicine RXRG001 at three different dose levels. The study team will have blood samples taken from all patients to see how their bodies are handling the study medicine. All patients will be closely monitored for side effects and safety concerns.
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.