North Ryde

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are conducting a first-in-human, open-label Phase I study to assess the safety, tolerability, pharmacokinetics, immune response, and early antitumor effects of AK138D1 in adults with advanced solid tumors. The study focuses on individuals whose cancer is locally advanced or metastatic and resistant or intolerant to standard treatments. The trial consists of two main parts: a dose-escalation stage to find the maximum tolerated or maximum administered dose, and a dose-expansion stage to determine the recommended dose for further study. Participants receive AK138D1 through intravenous infusion according to their assigned dosing plan. During the study, participants will be monitored for adverse events and dose-limiting toxicities for up to approximately two years. Researchers will also assess tumor response using measurable lesions, organ function, and overall health status. The total involvement includes signing consent, regular assessments, and safety follow-up to evaluate the drug's effects and tolerability.

Researchers are evaluating the safety and effectiveness of HLX22 combined with trastuzumab and chemotherapy as the first treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 2, double-blind, randomized, and multiregional study compares this combination against trastuzumab and chemotherapy with or without pembrolizumab. The study aims to measure how well the treatments work in controlling the disease and improving survival for up to five years. Participants will be randomly assigned to one of two groups. One group receives HLX22 at 15 mg/kg every three weeks along with trastuzumab, chemotherapy (XELOX regimen), and possibly a placebo for pembrolizumab. The other group receives a placebo for HLX22 plus trastuzumab, chemotherapy (XELOX), and possibly pembrolizumab every three weeks. Treatment continues until the disease worsens, unacceptable side effects occur, withdrawal of consent, or other protocol-specified reasons. Throughout the study, participants will undergo regular assessments including tumor scans reviewed by an independent committee to evaluate progression-free survival and overall survival over up to five years. Other evaluations include safety monitoring and organ function tests. The study tracks how long patients live without disease progression and overall survival, aiming to better understand the benefits and risks of HLX22 combined with current standard treatments.

Researchers are evaluating BGB-26808, alone or combined with tislelizumab, in participants with advanced solid tumors in an open-label, multicenter, nonrandomized Phase 1 study. This study aims to find the recommended dosing for BGB-26808 while assessing its safety, tolerability, pharmacokinetics, and early antitumor activity. Participants include those with advanced, metastatic, unresectable, or locally advanced tumors who may have limited treatment options or no prior therapy targeting HPK1. Participants receive BGB-26808 orally once daily as a tablet. Tislelizumab, when used, is given by intravenous infusion. Chemotherapy may also be administered following local guidelines or prescribing information. The study includes dose escalation and dose expansion phases to determine the maximum tolerated dose, maximum administered dose, and the recommended dose for further study. During the study, participants undergo regular monitoring for adverse events and serious adverse events up to about 12 months after dosing or until starting new anticancer therapy. Effectiveness is measured by overall response rate around 6 months. Researchers will collect tumor tissue samples, assess organ function, and evaluate performance status. Participants are followed closely with safety checks and evaluations of treatment response throughout the study duration.

Researchers are evaluating AMG 732 in both healthy individuals and participants with moderate-to-severe active Thyroid Eye Disease (TED) in a Phase 1/2 clinical trial. The study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of AMG 732 given by subcutaneous injection. Part A focuses on safety and tolerability after single doses in healthy participants, while Part B examines the efficacy of multiple doses in those with TED. Participants receive either AMG 732 or a placebo through subcutaneous injections. Part A involves single-dose administration to healthy adults aged 18 to 55 years, including a cohort of healthy Japanese participants. Part B enrolls adults aged 18 to 65 years with moderate-to-severe active TED, who receive multiple doses over approximately six months. The study design is randomized, double-masked, and placebo-controlled. During the trial, participants undergo various evaluations including safety monitoring for treatment-emergent adverse events up to 36 weeks, and measurement of proptosis (eye bulging) changes in the affected eye from baseline to the end of treatment. Assessments include clinical activity scores, laboratory tests, vital signs, ECGs, and physical exams. Researchers also track participants’ response to treatment and monitor for any side effects throughout the study duration.

Researchers are evaluating the safety, preliminary effectiveness, and how the body processes DM005, an experimental drug targeting advanced solid tumors including non-small-cell lung cancer, head and neck squamous cell carcinoma, and other solid carcinomas. This first-in-human, open-label, multicenter Phase 1 study aims to find the maximum tolerated dose and assess dose-limiting toxicities of DM005, a bispecific antibody-drug conjugate targeting c-MET and EGFR. The study includes participants with advanced solid malignant tumors who have progressed on or are intolerant to standard therapies and have measurable disease. Participants will receive DM005 through intravenous infusion once every 21 days (Q3W) in treatment cycles. The first dose is given over about 60 minutes, with subsequent doses possibly infused over 30 minutes if no infusion-related reactions occur. The study includes a screening period of up to 28 days, followed by repeated 21-day treatment cycles, an end-of-treatment visit within 7 days after the last dose, and a follow-up visit approximately 30 days later. Dose adjustments may be made based on safety and pharmacokinetic data. Throughout the study, participants will undergo safety monitoring including evaluation of toxicities and measurement of disease response using RECIST criteria. Researchers will collect pharmacokinetic data and monitor for infusion-related reactions and other adverse effects. The study assesses dose-limiting toxicities and maximum tolerated dose over 12 months, with life expectancy and performance status evaluated to ensure participant suitability and safety during treatment.

Researchers are evaluating whether adding JNJ-90301900 to standard concurrent platinum-based doublet chemotherapy with radiation therapy followed by consolidation immunotherapy can improve the objective response rate in participants with locally advanced and unresectable stage III non-small cell lung cancer. This phase 2, randomized, open-label study focuses on participants diagnosed recently with NSCLC and eligible for this combined treatment approach. Participants will receive JNJ-90301900 injected directly into tumors or lymph nodes alongside concurrent chemo/radiation therapy, which includes carboplatin and paclitaxel administered intravenously and radiation delivered by intensity modulated radiation therapy. Following this, consolidation immunotherapy with intravenous durvalumab will be given. The study evaluates this combined treatment sequence against standard care approaches. During the study, participants will undergo assessments including imaging to measure tumor response according to RECIST criteria, with the primary outcome being the objective response rate over up to 2 years and 2 months. Researchers will monitor safety and treatment effects throughout, ensuring participants meet performance status criteria and have lesions suitable for injections and radiation. The study involves ongoing evaluations guided by independent central review.

Researchers are investigating JNJ-95566692 alone and combined with JNJ-87801493 in people with B-cell non-Hodgkin lymphoid malignancies that have returned or not responded to previous treatments. The study aims to find the recommended Phase 2 doses (RP2Ds) and best dosing schedules through dose escalation, then further examine the safety and clinical effects at these doses in a dose expansion phase. This Phase 1 trial focuses on patients who have had at least two prior therapies including an alphaCD20 monoclonal antibody chemotherapy combination. JNJ-95566692 and JNJ-87801493 are given by subcutaneous injection. The study has two parts: Part 1 involves increasing doses to identify the RP2Ds for JNJ-95566692 alone (Arm A) and combined with JNJ-87801493 (Arm B). Part 2 expands treatment at these doses to better understand safety and clinical activity. Participants receive these injections according to the study schedule during these periods. Participants will be monitored for adverse events and serious adverse events over about two years and eight months, including dose limiting toxicities during dose escalation. Safety and clinical responses are tracked through regular assessments. Participants must meet specific health and disease criteria and agree to pregnancy prevention measures during treatment and for three months after. The total participation time includes screening, treatment, and follow-up as outlined in the study.

Researchers are evaluating the effectiveness and safety of adding Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as the first treatment for adults with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer. This phase 3 study focuses on participants whose cancer has a specific genetic change called a PIK3CA mutation and who have not received prior treatment for advanced breast cancer. The study aims to understand how well this treatment combination works and its safety over time. Participants will receive Tersolisib or a placebo, combined with a CDK4/6 inhibitor (Ribociclib, Palbociclib, or Abemaciclib) and endocrine therapy (Anastrozole, Letrozole, Exemestane, or Fulvestrant). All drugs are given orally except for Fulvestrant, which is given by injection into the muscle. The study includes two parts: Part 1 allows participants who have had up to two prior treatments for advanced breast cancer, including chemotherapy; Part 2 includes those with no prior treatment for advanced disease and classifies them as endocrine sensitive or resistant based on their cancer history. During the study, participants will be regularly assessed for cancer response, progression-free survival, and side effects. Researchers will monitor measurable disease or bone involvement and track overall response rates, including complete or partial tumor shrinkage. The study will continue as long as the treatment is helping without causing unbearable side effects. Follow-up may last up to five years to observe long-term outcomes and safety.

Researchers are evaluating the safety and effectiveness of bevacizumab, a drug injected directly into the shoulder joint, for adults with adhesive capsulitis, commonly known as frozen shoulder. This clinical trial is a phase II, open-label, dose-ranging study conducted at a single center. It aims to find the highest dose of bevacizumab that can be given safely without severe side effects and to assess its impact on pain and shoulder movement in participants diagnosed with adhesive capsulitis lasting between 2 and 6 months. Participants will receive one injection of bevacizumab into the affected shoulder joint. The study uses a stepwise approach with increasing doses starting at 50mg and potentially increasing to 200mg, following a "3+3 design" to monitor for dose-related toxicities. The trial plans to enroll up to 28 participants divided into dose cohorts, with safety evaluations guiding dose escalation or stopping. The entire study lasts for one year with multiple follow-up visits. After the injection, participants will return to the study site six times over 12 months for safety checks, pain questionnaires, and range of motion tests done by a physiotherapist. Researchers will monitor side effects and measure how well participants' shoulders recover movement and reduce pain. The main outcomes include evaluating safety over 52 weeks and determining the maximum tolerated dose within one week after treatment. This study is sponsored by Macquarie University and involves detailed assessments including imaging and laboratory tests to ensure participant safety and study accuracy.