North Melbourne

Researchers are evaluating the effectiveness and safety of nipocalimab compared to placebo in adults with generalized myasthenia gravis (gMG), a condition causing muscle weakness. This phase 3, multicenter, randomized, double-blind study also includes a subcutaneous substudy to assess how nipocalimab works in the body when given as an injection under the skin compared to intravenous infusion. Participants will receive nipocalimab or a matching placebo through intravenous infusion. In the subcutaneous substudy, nipocalimab will be administered under the skin. The study includes groups receiving different forms of the drug, with dosing schedules detailed in the protocol. The subcutaneous substudy requires participants to maintain stable doses of corticosteroids and/or immunosuppressants for the first 8 weeks. During the study, participants will undergo assessments including the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score measured at baseline and weeks 22 to 24. Blood samples will be collected to measure antibody levels and total IgG from before the first dose up to week 8 in the sub-study. Safety and efficacy will be closely monitored throughout the trial period.

Researchers are conducting an open-label pilot study to evaluate a new imaging agent called MNPR-101-DFO*-89Zr in patients with various solid tumor cancers, including bladder, triple-negative breast, lung, colorectal, gastric, ovarian, and pancreatic cancers. This agent combines a humanized monoclonal antibody with the radioactive isotope Zirconium-89 and is designed to help detect tumors using PET/CT scans. The study aims to assess how the agent distributes in the body, its tumor detection ability, safety, and blood pharmacokinetics. Participants will receive a single intravenous infusion of MNPR-101-DFO*-89Zr on Day 1, with doses ranging from 37 to 74 MBq of Zirconium-89 and antibody doses increased stepwise up to 80 mg. After infusion, participants will undergo three PET/CT scans: approximately 2 hours post-infusion on Day 1, once between Days 3-5, and once between Days 7-10. Blood samples will also be collected six times at scheduled intervals on Day 1, Days 3-5, and Days 7-10 to measure pharmacokinetics. During the study, researchers will evaluate tumor uptake values and dosimetry including key organs like liver, kidney, bone marrow, and lungs. The safety of the imaging agent will be monitored through Day 30 after infusion using standardized criteria. Participants will be followed for one month post-infusion, with assessments including scans, blood tests, and safety evaluations to gather comprehensive data on the agent's performance and tolerability.

Researchers are studying the safety and appropriate dosing of MNPR-101-PCTA-177Lu, a treatment given to adults with various solid tumor cancers, including bladder, breast, lung, colorectal, gastric, ovarian, and pancreatic cancers. This phase 1a, open-label, uncontrolled, multi-center trial enrolls patients who previously participated in a related imaging study. The study aims to identify dose-limiting toxicities and monitor treatment-emergent adverse events over a 24-week period. The treatment involves three intravenous infusions of MNPR-101-PCTA-177Lu administered over about 20 minutes each, given on Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (12 weeks after the first dose). Dose levels range from 480 to 2240 MBq, and dosing decisions for patient cohorts are guided by a Time-to-Event Bayesian Optimal Interval (TITE-BOIN) design. Imaging with SPECT and CT scans occurs at specific points during the study to evaluate tumor response and drug distribution. Dose delays are allowed for certain adverse events, and patients experiencing significant toxicity may stop treatment. Participants will be followed for safety for 12 weeks after their last dose, with evaluations including imaging, adverse event monitoring, and laboratory tests. The study measures how often dose-limiting toxicities occur within six weeks after the first dose and tracks all treatment-related adverse events up to 24 weeks. Total participation spans from dosing through follow-up, incorporating tumor response assessments using established criteria.

Researchers are evaluating the safety and effectiveness of an investigational drug called ficerafusp alfa combined with pembrolizumab compared to placebo with pembrolizumab in adults with PD-L1-positive recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). This study includes both Phase 2 and Phase 3 parts. Ficerafusp alfa targets two cancer-related proteins, EGFR and TGF-beta, which play roles in tumor growth and spread. The goal is to find the best dose and then compare treatment outcomes between groups. In Phase 2, participants will be randomly assigned to one of three groups: ficerafusp alfa 1500 mg weekly plus pembrolizumab every three weeks, ficerafusp alfa 750 mg weekly plus pembrolizumab every three weeks, or placebo weekly plus pembrolizumab every three weeks. Phase 3 will randomize participants to the selected ficerafusp alfa dose plus pembrolizumab or placebo plus pembrolizumab. Treatments will continue as scheduled, and safety, tolerability, and treatment responses will be closely monitored throughout. Participants will undergo assessments including scans to measure tumor response using RECIST 1.1 criteria, safety evaluations for side effects, and survival tracking. Safety monitoring includes checking for treatment-related adverse events up to 30 days after treatment ends and serious events up to 90 days afterward. The study will follow participants for approximately one year in Phase 2 and up to three years in Phase 3 to evaluate treatment effectiveness and overall survival.

Researchers are evaluating the effectiveness of brenetafusp (IMC-F106C) combined with nivolumab compared to standard nivolumab treatments in people who have advanced melanoma that has not been treated before. This study focuses on participants who have a specific genetic marker called HLA-A*02:01 and aims to understand how these treatments affect the progression of their cancer. The study is a phase 3, randomized, controlled trial, which helps ensure reliable comparison between the different treatment regimens. Participants in this study will receive either brenetafusp plus nivolumab or standard nivolumab regimens, which may include nivolumab alone or in combination with relatlimab. These treatments are given by intravenous infusion, with specific dosing of the drugs as concentrates for infusion. The study compares these approaches to see which is more effective in controlling the melanoma. During the study, participants will be closely monitored for disease progression and overall health. Researchers will use scans and other assessments to measure progression-free survival, which is the time participants live without their disease worsening, followed for up to about 45 months. Safety and response to treatment will be regularly evaluated to better understand the effects of the therapies over time.

Researchers are evaluating the safety and effectiveness of a new implantable device designed to treat erectile dysfunction following radical prostatectomy surgery. This study focuses on whether the device is safe to use and if it helps participants regain erectile function and satisfaction. Participants include men who have localized prostate cancer and are undergoing nerve-sparing prostatectomy. The device works by activating the pro-erectile nerves within the pelvic plexus through electrical pulses delivered on demand. It is implanted during the prostatectomy surgery. Participants will be divided into two groups: one group receives the device implant during surgery, and a control group does not. The device is intended to trigger erections and support natural erectile function recovery with daily electrical stimulation. During the 6-month follow-up, participants will visit the hospital for check-ups, complete questionnaires, activate the device daily, and measure erection hardness. Researchers will monitor adverse events, surgical complications, device performance, and pain levels to assess safety and tolerability. This study helps understand the device's potential benefits and risks over half a year of use.

Researchers are evaluating the safety and effectiveness of different first-line treatments for adults with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) cancer. The study focuses on participants whose tumors have a PD-L1 combined positive score (CPS) of 1 or higher in the main group, and an exploratory group with CPS less than 1. This phase 3 trial compares a new combination therapy to the current standard treatment to see which better controls the cancer progression. Participants will receive one of two treatment combinations. One group will get trastuzumab deruxtecan (T-DXd) given intravenously every three weeks along with a fluoropyrimidine chemotherapy drug and pembrolizumab, also given intravenously every three weeks. The comparison group will receive standard chemotherapy plus trastuzumab, with or without pembrolizumab depending on the group. Chemotherapy drugs include 5-FU or capecitabine, and in some arms, cisplatin or oxaliplatin will also be given. Treatments will be delivered in cycles every three weeks. During the study, researchers will monitor participants closely through scans and other tests to measure how long it takes for the cancer to worsen or for death from any cause. Participants must provide tumor tissue samples for biomarker testing before starting treatment. Heart function and lung health will also be regularly checked to ensure safety. The main outcome measured is progression-free survival over up to 59 months after randomization, with ongoing assessments throughout the treatment period.