Blacktown

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are investigating if intismeran autogene combined with pembrolizumab can prevent advanced melanoma from growing or spreading. Advanced melanoma is skin cancer that has spread to other parts of the body and cannot be removed with surgery. The study aims to see if people receiving intismeran autogene with pembrolizumab live longer without their cancer worsening than those receiving placebo with pembrolizumab. This is a phase 2 clinical trial evaluating these treatments in people with first-line advanced melanoma. Participants will receive either intismeran autogene or placebo via intramuscular injection every 3 weeks for up to 9 doses about 27 weeks. All participants will also receive pembrolizumab by intravenous infusion every 6 weeks for up to 17 doses, totaling around 2 years of treatment or until their disease progresses or they stop the treatment. The study compares the experimental combination to a placebo plus pembrolizumab to better understand the effects of intismeran autogene. During the study, participants will have regular assessments to measure how long they live without the cancer growing or spreading, as well as overall response and survival up to 6 years. Researchers will monitor side effects and reasons for stopping therapy for up to 2 years. Participants will undergo scans and tumor tissue analysis for biomarker studies. The trial includes a randomized design with triple masking and aims to enroll adults aged 18 and older with advanced melanoma.

Researchers are investigating new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

Researchers are evaluating the effects of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight who do not have Type 2 diabetes. This Phase III, randomized, double-blind study aims to assess both the efficacy and safety of once-weekly enicepatide in this population, addressing weight-related comorbidities such as prediabetes, hypertension, and cardiovascular conditions. Participants will be randomly assigned to receive either placebo or one of three enicepatide dosing regimens, administered once weekly via an integrated drug-device combination product. The treatment phase lasts through 72 weeks, during which changes in body weight and other health measures are monitored. The study includes multiple assessments to track body weight percentage change, waist circumference, fasting glucose and insulin levels, lipid profiles, blood pressure, and quality of life measures. Throughout the study, participants will undergo regular evaluations including physical examinations, laboratory tests, and questionnaires related to physical functioning and urinary incontinence. Researchers will monitor adverse events, patient-reported health questionnaires, and biomarkers at baseline and weekly intervals through week 72. This long-term follow-up allows for a comprehensive assessment of treatment effects and safety in participants managing obesity or overweight without Type 2 diabetes.

Researchers are evaluating the safety, effectiveness, optimal dose, and behavior of an investigational drug called BNT326, alone or combined with other immunotherapy agents, in adults with advanced solid tumors. This study includes patients with tumors that have either spread metastatic, returned after treatment, or progressed despite previous therapies, across various cancer types such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. Participants are divided into two parts Part 1 tests BNT326 alone in different tumor-specific groups, some with dose randomization to find optimal dosing. Part 2 evaluates BNT326 alone or combined with another investigational drug called pumitamig in several cancer types, with some groups receiving randomized doses and others non-randomized treatments. Treatments are given via intravenous infusion, with some oral medications combined in Part 1. The study includes dose escalation and randomization phases, and treatment can continue for up to 24 months or until disease progression or other reasons. During the study, participants undergo screening, treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring phases. Researchers assess adverse events, treatment responses, disease progression, and drug behavior in the body using clinical evaluations and laboratory tests. Follow-up assessments occur up to approximately 38 months for Part 1 and 48 months for Part 2, with continued treatment possible for those benefiting from the therapy. The study aims to gather comprehensive data on safety, dosing, and effectiveness in this patient population.

Researchers are evaluating BG-C137, an antibody-drug conjugate targeting FGFR2b, in people with advanced solid tumors. This study aims to assess the safety, tolerability, how the drug moves and acts in the body, and early antitumor effects. It is a phase 1ab trial involving participants with tumors expressing FGFR2b or FGFR2 gene amplification who have received prior cancer treatments. The study is sponsored by BeOne Medicines and includes two main phases dose escalation and dose expansion. The trial has three parts Phase 1a evaluates increasing doses of BG-C137 alone and then in combination with other anticancer agents to establish safe dose levels. Phase 1b further explores the recommended dose in selected patient groups. BG-C137 and anticancer agents are given intravenously or orally depending on the treatment. Participants undergo dose escalation, safety expansions, and dose confirmations to determine the best dosing for further study. Participants will be monitored regularly for side effects and response to treatment for up to about two years. Assessments include measuring adverse events, drug levels in the blood, tumor response, and immune reactions to the drug. Safety follow-up visits occur after treatment ends. Researchers will measure outcomes such as maximum tolerated dose, overall response rate, disease control, and progression-free survival. The trial involves frequent visits for treatment and assessments throughout the study period.

Researchers are evaluating BG-C0902, a new antibody-drug conjugate targeting the epidermal growth factor receptor EGFR and mesenchymal-epithelial transition MET in people with advanced solid tumors. This first-in-human Phase 1a1b study aims to assess the safety, tolerability, how the drug behaves in the body pharmacokinetics and pharmacodynamics, and early signs of its ability to fight tumors. The study is sponsored by BeOne Medicines and includes two phases dose escalation and safety expansion Phase 1a and dose expansion Phase 1b. Participants will receive BG-C0902 through intravenous infusion in doses that increase over time during Phase 1a to find the recommended dose for further study. In Phase 1b, this recommended dose will be tested in selected tumor types. The study does not use randomization or blinding and involves sequential patient groups receiving the drug alone or in combination with other treatments. During the study, participants will undergo evaluations for adverse events, dose limiting toxicities, and tumor responses over approximately two years. Researchers will monitor blood levels of the drug and related antibodies, assess tumor changes using standard criteria, and check overall health status. Safety and effectiveness measurements will be collected regularly, with follow-up to understand how well participants respond and tolerate the treatment over time.

Researchers are evaluating the safety and anti-tumor activity of DZD6008, an oral EGFR inhibitor, in patients with advanced non-small cell lung cancer NSCLC that have EGFR mutations. This Phase 1, open-label study includes patients with locally advanced or metastatic NSCLC who have specific EGFR mutations and either have been previously treated with EGFR tyrosine kinase inhibitors TKIs or are treatment-nave. The study aims to better understand how DZD6008 works in this patient group and assess its tolerability and anti-cancer effects. The study has two parts Part A focuses on dose escalation, enrolling patients who have failed at least one prior EGFR TKI therapy. Multiple dose levels of DZD6008 are tested, ranging from 20 mg to 150 mg daily, including combination cohorts. Part B is a dose expansion phase that includes patients who have either failed one line of third-generation EGFR TKI or are treatment-nave, to further evaluate selected doses of DZD6008. Participants take the study drug orally once daily during these periods. Participants will undergo regular safety and tumor assessments throughout the study, typically for about one year. Researchers will monitor blood levels of DZD6008 and its metabolites, assess tumor response using RECIST 1.1 criteria, and evaluate overall tolerability. Safety evaluations include laboratory tests, ECGs, and monitoring for adverse events. The study collects tumor samples before treatment and tracks disease progression and patient well-being during follow-up.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and recommended phase 2 dose of D3S-002 given orally in adult patients with advanced solid tumors that have mutations in the mitogen-activated protein kinase MAPK pathway. This first-in-human study includes different parts assessing D3S-002 alone or combined with D3S-001 in patients with specific tumor types, including non-small cell lung cancer without certain genetic mutations. The study has two main parts Part 1 is a dose escalation phase where D3S-002 is given orally alone. Part 2 includes a dose escalation phase and a dose expansion phase where participants receive both D3S-002 and D3S-001 orally. Treatments are given in 21-day cycles, and doses are adjusted to find the recommended phase 2 dose. Participants will be monitored from the first dose up to 24 months, with assessments including adverse events, dose-limiting toxicities, and pharmacokinetic measurements such as drug concentrations in the blood. Tumor response will also be evaluated using standardized criteria. Safety, tolerability, and effectiveness measurements will be collected throughout the study, and participants may be followed for up to two years after starting treatment.