Sydney

Researchers are evaluating the safety of increasing doses of 131I-TLX101 given intravenously alongside standard care in patients newly diagnosed with glioblastoma, a type of brain tumor. This open-label, single-arm, multicenter Phase 1 study focuses on patients with histologically confirmed glioblastoma who have undergone surgery but not yet received systemic or radiation therapy. Participants receive ascending doses of 131I-IPA intravenously via infusion combined with the best standard of care, including planned chemoradiation therapy starting 3 to 6 weeks after surgery. The study monitors safety and dose-limiting toxicities over multiple dose levels to identify the recommended Phase 2 dose. During the 62-week study, participants undergo regular evaluations including clinical assessments, lab tests such as liver function, and monitoring for treatment-emergent adverse events. Researchers measure the incidence and severity of dose-limiting toxicities from the first dose until discharge after the second dose, along with overall safety and tolerability throughout the study period.

Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that attack cancer while minimizing stimulation of cells that suppress immunity. This Phase 1/2 open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumors. The study includes dose-escalation and dose-expansion parts for both monotherapy and combination therapy with pembrolizumab. MDNA11 is given intravenously every two weeks with doses ranging from 0.003 to 0.6 mg/kg for monotherapy, while dose ranges for combination therapy are also evaluated. Treatment continues until progression, withdrawal, or loss to follow-up, with tumor assessments by CT or MRI every 8 weeks. Participants will undergo regular imaging scans every 8 weeks to monitor tumor response and safety assessments throughout the 24-month study. Researchers will track recommended doses for expansion, treatment-related adverse events, and overall safety. The study involves up to 115 patients across multiple sites and includes long-term monitoring for up to 24 months.

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are studying a medicine called enlicitide to reduce low-density lipoprotein cholesterol (LDL-C) in adults with high cholesterol (hyperlipidemia). This trial aims to find out if taking enlicitide together with rosuvastatin, a standard cholesterol-lowering drug, works better than a placebo in lowering LDL-C levels. The study is a Phase 3 trial that is randomized, double-blind, and placebo-controlled to ensure accurate and unbiased results. Participants will receive oral tablets of enlicitide or placebo along with oral capsules of rosuvastatin or placebo. The study compares the effect of enlicitide plus rosuvastatin against placebo to evaluate their impact on LDL-C. The treatment period lasts 8 weeks, during which participants take their assigned medications as directed. During the study, researchers will measure the average percent change in LDL-C from the start of the trial to week 8. Participants will be monitored for safety and any side effects throughout the study. The total participation time includes screening, treatment, and follow-up assessments to evaluate the medicines' effects and safety in adults aged 18 to 64 with hyperlipidemia.

Researchers are evaluating the safety and tolerability of MK-4716, a drug being studied alone or in combination with other treatments, in people with certain advanced or metastatic solid tumors that have a KRAS alteration. This phase 1, open-label study focuses on participants with locally advanced unresectable or metastatic solid tumors or metastatic non-small cell lung cancer. The study aims to understand how well MK-4716 is tolerated and its safety profile, including monitoring for dose-limiting toxicities and adverse events. Participants receive MK-4716 orally, either as monotherapy or combined with pembrolizumab or cetuximab, both given by intravenous infusion. Different study arms target specific patient groups: one arm includes MK-4716 alone or with cetuximab for solid tumors with KRAS alteration, while another arm combines MK-4716 with pembrolizumab for untreated metastatic non-small cell lung cancer with KRAS alteration. The study includes a dose escalation phase to determine safe dosing. Throughout the study, participants are regularly monitored for side effects, adverse events, and any reasons for stopping the study treatments over approximately five years. Researchers track dose-limiting toxicities within about 28 days of treatment and assess safety, pharmacokinetics, and efficacy. Participants must have measurable disease and the ability to take oral medication to join the trial.

Researchers are evaluating the safety, tolerability, and how the body processes HRS-3802 when given alone to patients with advanced malignant solid tumors. This Phase 1 clinical trial focuses on patients who have not responded to standard treatments or for whom no effective standard treatments exist. The study aims to understand how well patients tolerate HRS-3802 and to collect important safety and dosage information. Participants will receive HRS-3802 as a monotherapy. The study is open-label and single-arm, meaning all participants receive the investigational drug without a comparison group. The treatment period includes monitoring for dose-limiting toxicities during the first 28 days, with assessments at 3 weeks for maximum tolerated dose and recommended Phase II dose. The treatment and monitoring occur over an average duration of 5 months, with safety evaluations every 4 weeks after treatment starts. During the study, participants will be regularly assessed for side effects and how severe these are, using various tests and clinical evaluations. Researchers will collect data on adverse events, dose tolerability, and pharmacokinetics of HRS-3802. Participants will also undergo laboratory tests, physical examinations, and follow-up visits to monitor their health and treatment effects. The total involvement time in the study is around five months, with careful safety oversight throughout.

Researchers are studying a condition called facioscapulohumeral muscular dystrophy (FSHD) Type 1, which affects adults aged 18 to 75 years. The trial aims to learn how safe and tolerable a new therapy called EPI-321 is, and to see if there are early signs it might work. EPI-321 is an investigational gene therapy designed to target the root cause of FSHD by delivering an epigenetic editor directly to muscle tissue to reduce harmful protein production. Participants will receive a single intravenous dose of EPI-321, with two different dose levels being tested in an open-label, dose-escalation format. After the infusion, participants will be closely monitored in a hospital setting and will attend regular clinic visits for tests and checkups over about 5 years. These visits will include assessments of muscle function, imaging, and other disease markers to help evaluate the drug's biological activity. During the study, researchers will track safety by monitoring any adverse events and reactions related to EPI-321 for up to 5 years. Participants will undergo various tests, including laboratory checks and imaging, to assess muscle health and disease progression. The study will also evaluate how well participants tolerate the treatment over time and collect data that may help design future clinical trials.

Researchers are evaluating IBI354, a recombinant anti-HER2 monoclonal antibody-camptothecin derivative conjugate, in adults with locally advanced unresectable or metastatic solid tumors. This Phase 1/2, open-label, multicenter study aims to determine the safety, tolerability, dose-limiting toxicities, maximum tolerated dose, maximum administered dose, and recommended Phase 2 dose of IBI354. The study also explores and confirms the drug's efficacy, safety, and tolerability in this patient population. Participants receive sequential doses of IBI354 during the study. The trial includes a Phase 1a dose-escalation period to establish dose limits and Phase 1b/2 periods enrolling subjects with specific solid tumors expressing HER2 to evaluate treatment effects. Dosing schedules and administration details are guided by safety and tolerability findings. The study drug is administered as an injection. Throughout the study, researchers monitor participants for serious adverse events and treatment-emergent side effects up to 30 days after the last dose. Dose-limiting toxicities are specifically assessed during the first 21 days of treatment in Phase 1a. Participants undergo evaluations including echocardiography to check heart function before drug administration. Safety, response, and tolerability are closely followed to understand the treatment impact and support future dosing decisions.

Researchers are investigating new treatments for children and young people with relapsed or refractory B-cell non-Hodgkin Lymphoma (B-NHL), a type of cancer affecting lymph nodes and organs like the liver or spleen. Current treatments have limited success and many side effects, curing only about 30% of patients. This global trial aims to find better and safer medicines by testing novel agents in this rare cancer setting, using an adaptive trial design that allows continuous evaluation and adjustment. The trial has three treatment groups, each testing a different new medicine: bispecific antibodies (BsAbs), antibody-drug conjugates (ADC) combined with standard chemotherapy, and chimeric antigen receptor (CAR) T-cells. Patients may be assigned to any available group they qualify for, and if a treatment does not work, they might switch to another group. The trial uses a Bayesian adaptive design to efficiently decide whether a treatment is effective and can stop ineffective treatments early to introduce new ones. Participants will receive the assigned treatments and be monitored closely through scans, biopsies, and laboratory tests to evaluate disease response and safety. The main outcomes include measuring objective responses and complete remissions at specified time points. Children and young people will be followed for at least two years after treatment to monitor for side effects and long-term health. The study includes comprehensive assessments and is conducted across multiple international centers.

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.