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.
A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
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 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.