North Ryde

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating HLX48, an EGFRc-MET bispecific antibody-drug conjugate, in patients with advanced or metastatic solid tumors. This open-label phase I clinical trial aims to assess the safety, tolerability, and pharmacokinetic profile of HLX48 given at increasing doses. The trial uses a 33 dose escalation design to carefully study the effects and side effects of HLX48 in this patient population. Participants will receive HLX48 via intravenous infusion at one of six preset dose levels. The dose-limiting toxicity DLT observation period lasts for 3 weeks after the first dose, during which the Safety Review Committee reviews safety data to decide on dose escalation or cohort expansion. New dose groups may be added based on safety, tolerability, pharmacokinetics, immunogenicity, and efficacy data. Those who withdraw early for reasons unrelated to toxicity may be replaced. Throughout the study, participants will undergo evaluations including tumor measurements by RECIST v1.1, ECOG performance status assessments, and laboratory tests to confirm organ function. Safety monitoring includes dose-limiting toxicity and maximum tolerated dose assessments within the first cycle of treatment. Secondary outcomes such as response rates, survival, and antibody development will be tracked for up to 24 months. Participants are followed closely during and after treatment to collect comprehensive data on HLX48s effects.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor effects of AK138D1 in adults with advanced solid tumors. This first-in-human, open-label Phase I trial includes patients whose tumors are resistant or intolerant to standard treatments, aiming to better understand this new drugs potential. The study includes two parts dose escalation to find the maximum tolerated dose and dose expansion to determine the recommended dose for further research. Participants will receive AK138D1 through intravenous infusions at pre-determined dose levels based on their study group. The first part focuses on gradually increasing doses to identify safe limits, while the second part treats more patients with the recommended dose to further assess safety and early effectiveness. This process helps define appropriate dosing for future studies. During the trial, participants will undergo regular monitoring for side effects and dose-related toxicities for up to two years. Researchers will perform scans and measurements to track tumor response using standard criteria and collect blood samples to study drug levels, immune reactions, and survival outcomes. The study also tracks how long participants respond to treatment and how long they live without disease progression, providing a comprehensive view of safety and preliminary benefits over time.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating BGB-26808, alone or combined with tislelizumab, in people with advanced solid tumors that are metastatic or cannot be removed by surgery. This open-label, multicenter, nonrandomized Phase 1 study aims to find the recommended doses of BGB-26808 and assess its safety, tolerability, and early antitumor activity. The study is sponsored by BeOne Medicines, previously known as BeiGene. Participants will receive increasing doses of BGB-26808 either by itself or combined with tislelizumab and chemotherapy, depending on the study phase. BGB-26808 is given daily as an oral tablet, while tislelizumab is administered by intravenous infusion. The study includes a dose escalation phase Phase 1a and a dose expansion phase Phase 1b to evaluate appropriate dosing and response. During the study, participants will be monitored for adverse events and serious adverse events from the first dose until 90 days after the last dose or start of new treatment, for up to about 12 months. Researchers will also measure tumor response rates, duration of response, disease control, clinical benefit, and pharmacokinetic properties like drug concentration in the blood. Study visits will include tumor assessments, blood tests, and safety evaluations over several months.

Researchers are evaluating the safety, effectiveness, and tolerability of an experimental drug called DM005 in patients with advanced solid tumors. This first-in-human, open-label study aims to understand how DM005, a bispecific antibody-drug conjugate targeting c-MET and EGFR, behaves in the body and its preliminary impact on tumor response. Participants must have advanced solid malignant tumors that are not curable by standard local therapies and have progressed on or are intolerant to standard treatments. Participants receive DM005 intravenously on Day 1 of each 21-day cycle. The initial infusion lasts about 60 minutes, and if no infusion-related reactions occur, subsequent infusions may be shortened to about 30 minutes. The study includes a screening period of up to 28 days, followed by multiple treatment cycles, an end-of-treatment visit within 7 days after the last dose, and a follow-up visit about 30 days later. Dose escalation and expansion allow assessment of different dose levels to determine the maximum tolerated dose. During the study, participants will undergo safety evaluations, pharmacokinetic testing, and tumor assessments using RECIST criteria to measure treatment response. Researchers monitor dose-limiting toxicities and other safety data throughout the study. The primary outcomes focus on safety and determining the highest safe dose. Participants can expect regular visits for infusions and assessments over the treatment period, with follow-up visits to monitor ongoing effects, lasting up to 12 months for outcome evaluations.

Researchers are evaluating whether adding the investigational drug JNJ-90301900 to standard concurrent platinum-based doublet chemotherapy with radiation therapy cCRT, followed by consolidation immunotherapy cIT with durvalumab, can improve the objective response rate in participants with locally advanced and unresectable stage III non-small cell lung cancer NSCLC. This Phase 2 study aims to compare the safety and efficacy of JNJ-90301900 in combination with cCRT and cIT against cCRT and cIT alone. The study is sponsored by Johnson & Johnson Enterprise Innovation Inc. Participants will be randomly assigned to one of three groups two experimental arms where JNJ-90301900 is injected intratumorally andor intranodally at different percentages of gross tumor volume 22% or 33% along with cCRT and followed by cIT, and a control arm receiving cCRT followed by cIT without JNJ-90301900. Chemotherapy drugs include carboplatin and paclitaxel administered intravenously, radiation therapy is delivered by intensity modulated radiation therapy IMRT, and consolidation immunotherapy is given as durvalumab through intravenous infusion. During the study, participants will undergo regular assessments to monitor tumor response using objective response rate evaluations up to 2 years and 2 months. Other measures include disease control rate, progression-free survival, duration of response, and safety evaluations such as adverse event monitoring, laboratory tests, physical exams, and vital signs. The total participation duration spans treatment and follow-up to assess long-term outcomes and safety of the treatment combinations.

Researchers are evaluating the safety and clinical activity of a new drug called JNJ-95566692 alone and in combination with another drug, JNJ-87801493, for treating adults with B-cell non-Hodgkin lymphoid malignancies who have relapsed or refractory disease. This Phase 1 study aims to find the best doses and schedules for these treatments and to further assess their effects in patients who have already tried other therapies. Participants will receive escalating doses of JNJ-95566692 alone or with JNJ-87801493 during the first part of the study to determine optimal dosing. In the second part, participants will receive these drugs at the recommended doses to better understand safety, how the body processes the drugs, and their clinical impact. Both drugs are given as injections under the skin. Throughout the study, participants will be closely monitored for side effects and treatment responses over about two years and eight months. Assessments include measuring drug levels in the blood, monitoring immune responses, and evaluating disease status. Safety and effectiveness data will be collected regularly to help guide further development of these treatments.

Researchers are evaluating the addition of Tersolisib LY4064809STX-478 to other anti-cancer drugs as a first treatment for adults with advanced hormone receptor-positive HRhuman epidermal growth factor receptor 2-negative HER2- breast cancer that has a PIK3CA mutation. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand the efficacy and safety of this combination compared to placebo, focusing on improving outcomes for patients with this specific genetic change. Participants receive LY4064809 orally in one of two doses combined with a CDK46 inhibitor such as Ribociclib, Palbociclib, or Abemaciclib and endocrine therapy ET administered orally or via intramuscular injection. The comparison group receives a placebo combined with the same CDK46 inhibitor and ET. The study includes two parts Part 1 explores dose optimization, and Part 2 evaluates the treatment combinations effectiveness and safety as a first-line therapy. During the study, participants will have regular assessments to monitor cancer response, progression, and safety over an estimated period of up to 5 years or more. Researchers will measure outcomes such as overall response rate, progression-free survival, duration of response, overall survival, and quality of life. Treatment continues as long as the cancer benefits without intolerable side effects. Safety monitoring, laboratory tests, and quality of life questionnaires are part of the participant involvement throughout the trial.

Researchers are studying a condition called adhesive capsulitis, also known as frozen shoulder. The study aims to evaluate the safety and effects of bevacizumab, a drug injected directly into the shoulder joint, and to determine the highest dose that can be given without causing serious side effects. This phase II trial is led by Macquarie University and will include up to 28 adults diagnosed with frozen shoulder. Participants will receive a single injection of bevacizumab in one of four doses 50mg, 100mg, 150mg, or 200mg. The trial uses a dose-escalation design, starting with low doses and increasing only if safety allows. After the injection, participants will be monitored closely for dose-limiting toxicities before moving to higher doses or stopping if side effects occur. The highest dose planned is 200mg, with up to 10 participants in this group unless safety concerns arise. Over the next year, participants will visit the study site six times for safety checks, pain questionnaires, and movement tests led by a physiotherapist. Researchers will assess the safety of bevacizumab over 52 weeks and identify the maximum tolerated dose within one week after injection. They will also track how well the treatment works to reduce symptoms of frozen shoulder during this period.