Sydney

Researchers are evaluating the safety and appropriate dose of increasing levels of the radioactive drug 131I-TLX101, given by intravenous infusion, combined with the best standard care in adults newly diagnosed with glioblastoma, a type of brain cancer. This open-label, single-arm study is conducted across multiple centers and aims to understand how patients tolerate this treatment alongside standard therapies. Participants receive escalating doses of 131I-TLX101 through an intravenous infusion along with the standard chemoradiation therapy known as the Stupp regimen, beginning 3 to 6 weeks after surgical removal of the tumor. The study includes a dose-finding phase to establish the recommended dose, with safety monitored throughout. The radioactive drug is administered in ascending doses, and the study observes participants for up to 62 weeks. During the study, participants will undergo regular safety assessments including laboratory tests of liver and kidney function, monitoring for adverse events, and evaluations of treatment-related toxicities for up to 62 weeks. Researchers will track the incidence and severity of dose-limiting toxicities and treatment-emergent adverse events. Participants must comply with radiation safety guidelines and attend scheduled visits for monitoring. The total study duration from screening until the end is about 62 weeks.

Researchers are evaluating MDNA11, a long-acting beta-only recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 12 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11s effects alone and with pembrolizumab.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.

Researchers are evaluating the safety and tolerability of HRS-7525 tablets in men with advanced prostate cancer. The study aims to identify dose limiting toxicity DLT, the maximum tolerated dose MTD, and the recommended Phase II dose RP2D of this drug. This Phase I trial focuses on patients with metastatic adenocarcinoma of the prostate, excluding neuroendocrine or small cell carcinoma types. Participants will receive HRS-7525 tablets during a single-group treatment period. The study includes a single-dose run-in period lasting 2 days, followed by 21 days after the first dose to assess dose limiting toxicity. The overall safety follow-up for each participant extends to about 13 months from informed consent to evaluate the maximum tolerated dose and recommended Phase II dose. During the study, participants will be monitored through clinical assessments to track safety, tolerability, and dosing effects. Researchers will evaluate adverse events, laboratory tests, and imaging to confirm metastatic lesions. Men with female partners of childbearing potential must use contraception during and for three months after treatment. The total participation duration includes the treatment period plus safety follow-up lasting approximately 13 months.

Researchers are evaluating the safety and tolerability of MK-4716, a drug being studied alone or combined with other treatments in people with certain advanced or metastatic solid tumors that have KRAS alterations. This phase 1, open-label study includes participants with locally advanced unresectable or metastatic solid tumors or metastatic non-small cell lung cancer, focusing on those with measurable disease and specific prior treatment histories. Participants receive MK-4716 at varying dose levels and schedules as monotherapy or combined with Pembrolizumab or Cetuximab. MK-4716 is given orally, while Pembrolizumab and Cetuximab are administered intravenously. The study uses a parallel design with several experimental arms to assess different combinations and dosing. During the study, participants are monitored for dose-limiting toxicities up to about 28 days and for adverse events up to approximately four years. Researchers measure drug concentrations in the blood at designated timepoints, pharmacokinetics, and overall safety. Participants undergo regular evaluations to assess side effects, treatment tolerability, and disease status throughout the study period, which lasts until study completion in December 2030.

Researchers are evaluating the safety, tolerability, and how the body processes HRS-3802 when used alone in patients with advanced malignant solid tumors. This phase I clinical study aims to better understand these factors in patients whose tumors have either not responded to standard treatments or for whom no effective standard treatments exist. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. Participants will receive HRS-3802 as a single treatment. The study is open-label, meaning both participants and researchers know the treatment being given. The research includes monitoring for side effects and determining the maximum tolerated dose and recommended dose for future studies. Treatment effects will be assessed over several months, with follow-up evaluations up to two years for progression and response. During the study, participants will be monitored regularly for adverse events, dose-related toxicities, and tumor response using RECIST 1.1 criteria. Safety assessments will occur every four weeks, especially during the first 28 days of treatment. Researchers will also evaluate outcomes such as objective response rate, duration of response, and progression-free survival. Participants are expected to survive at least 12 weeks and will be followed for up to two years to assess treatment impact and safety.

Researchers are exploring new treatment options for neovascular age-related macular degeneration NVAMD, a condition affecting the eyes. This trial aims to compare a new medicine called tiespectus also known as MK-8748 or EYE201 with the standard treatment aflibercept to see if tiespectus works as well in treating NVAMD. The study includes adults aged 50 and older who have not previously received treatment for this condition. Participants will be randomly assigned to one of three groups tiespectus low dose, tiespectus high dose, or aflibercept. Those in the tiespectus groups will receive three initial injections every 4 weeks, followed by injections every 8 weeks up to week 48. After week 48, treatment will continue at intervals based on individual response until week 92. The aflibercept group will receive three initial injections followed by injections every 8 weeks until week 92. During the study, participants will have their vision tested using the Best-Corrected Visual Acuity BCVA score and their eye structure examined with imaging techniques. Researchers will monitor changes in vision over one year and track any side effects up to approximately 96 weeks. Participants will attend regular visits for treatment and assessments throughout the study period lasting about 92 weeks.

This trial is designed for adults diagnosed with metastatic pancreatic ductal adenocarcinoma PDAC who have not yet received systemic treatment for their advanced cancer and have a good performance status. The study evaluates pumitamig, an investigational drug, in combination with chemotherapy to assess its safety and effectiveness. This phase II trial plans to explore different chemotherapy regimens combined with pumitamig to understand their impact on the disease.

Researchers are evaluating IBI354, a recombinant anti-HER2 monoclonal antibody-camptothecin derivative conjugate, in people with locally advanced unresectable or metastatic solid tumors. This Phase 12, open-label, multicenter study aims to assess the safety, tolerability, and dose-limiting toxicities to find the maximum tolerated or administered dose and the recommended Phase 2 dose of IBI354. The study also explores the drugs effectiveness and safety in this patient population. Participants receive sequential doses of IBI354 through a single-arm treatment plan. The study includes a Phase 1a dose escalation period to determine safety and dosing limits, followed by Phase 1b2 periods focusing on selected solid tumors expressing HER2. Treatment schedules and dosing details are designed to monitor tolerability and explore efficacy outcomes over time. During the study, participants undergo various assessments including monitoring for adverse events, dose-limiting toxicities within the first 21 days of treatment, and evaluation of objective response rate, duration of response, progression-free survival, and overall survival for up to two years. Safety evaluations continue up to 30 days after the last dose. Participants provide written informed consent and undergo cardiac function monitoring before treatment, with ongoing evaluations throughout their participation, which lasts as long as the study and follow-up periods continue.

Researchers are evaluating the safety, tolerability, and preliminary effectiveness of IMP1734, a PARP1 selective inhibitor, in people with advanced solid tumors. This study includes patients with breast cancer, metastatic prostate cancer, ovarian cancer, and other solid tumors who have previously received certain treatments. The goal is to find an optimal dose for future clinical development by studying how the drug affects the body and how the body processes it. The study has two parts Part 1 involves gradually increasing doses of IMP1734 given as a daily oral tablet to identify the highest safe dose or maximum achievable dose. This includes testing the drug alone and in combination with other treatments for specific cancers like metastatic prostate, ovarian, and breast cancer. Part 2 focuses on refining the dose to find the best amount for future studies. Treatment can last up to three years after the first dose. Participants will be monitored closely with assessments of side effects, blood tests to study drug levels and effects, and evaluations of tumor response using standard criteria. Safety monitoring continues up to 30 days after the last dose. Researchers measure how well the drug is tolerated and its impact on the cancer over time. The total participation may extend up to three years, with ongoing evaluations during this period.