Wahroonga

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are evaluating whether combining pasritamig with docetaxel can extend the time before prostate cancer worsens in men with metastatic castration-resistant prostate cancer mCRPC, a type of prostate cancer that continues to grow despite low hormone levels. This Phase 3 study compares pasritamig plus docetaxel against docetaxel alone to see if the combination improves radiographic progression-free survival rPFS, which is the time until disease progression or death as seen on scans. Participants are randomly assigned to receive either pasritamig together with docetaxel or docetaxel plus prednisoneprednisolone as background medication. Treatment continues until disease progression is confirmed by scans or other criteria are met. The study is open-label, meaning both participants and researchers know which treatment is given. During the trial, participants will have regular scans such as CT, MRI, or bone scans to monitor disease progression, assessed by independent review. Researchers will also evaluate overall survival, symptom progression, response rates, prostate-specific antigen PSA levels, quality of life measures, and safety by tracking adverse events and lab results. The study may last up to approximately 4 years and 5 months, with frequent assessments throughout.

Researchers are evaluating BMS-986365 compared to the investigators choice of therapy in men with Metastatic Castration-resistant Prostate Cancer. This phase 3, randomized trial aims to assess how well BMS-986365 works and how safe it is, focusing on radiographic progression-free survival. The study includes participants who have previously been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants are randomized into groups receiving either one of two dose levels of BMS-986365 or an active comparator treatment chosen by the investigator, which includes either Docetaxel plus PrednisonePrednisolone or Enzalutamide or Abiraterone plus PrednisonePrednisolone. The study has two parts Part 1 compares the different doses and comparator arms, while Part 2 focuses on the selected BMS-986365 dose versus the investigators choice. Dosing schedules are specified but not detailed here. During the study, participants undergo regular assessments including imaging scans to evaluate cancer progression, pain and symptom questionnaires, blood tests, electrocardiograms, and monitoring for adverse events. Outcomes measured include progression-free survival, overall survival, response rates, pain progression, and quality of life changes. The study may last up to 4 years, with ongoing safety and efficacy evaluations throughout this time.

Researchers are evaluating whether accelerated BEP chemotherapy is more effective than the standard BEP regimen for males aged 11 to 50 years with intermediate and poor-risk metastatic germ cell tumors. This phase 3 randomized trial aims to improve cure rates for these patients, as current treatments have limited success for higher-risk disease. The study is led by the University of Sydney and focuses on first-line chemotherapy outcomes for metastatic germ cell tumors. The study compares two treatment schedules standard BEP chemotherapy given every 3 weeks for 4 cycles, and accelerated BEP given every 2 weeks for 4 cycles followed by additional bleomycin doses. Both regimens include bleomycin, etoposide, cisplatin, and supportive growth factors like pegylated G-CSF or filgrastim, with dosing adjusted by age and weight. Treatment lasts about 12 weeks in both arms. Participants will undergo treatment cycles with regular intravenous chemotherapy infusions and weekly bleomycin doses. Researchers will assess progression-free survival up to 5 years after randomization, along with tumor response at the end of treatment and at 6 months. Safety will be monitored through adverse events, and quality of life will be measured up to 18 months. Overall survival and chemotherapy dose intensity are also tracked. The study involves multiple assessments and follow-up visits to monitor effects and outcomes.

Researchers are evaluating the combination of capivasertib with CDK46 inhibitors and fulvestrant in adults with hormone receptor-positive and HER2-negative locally advanced or metastatic breast cancer. This Phase IbIII study aims to determine the safe dose for the combination treatment in the initial Phase Ib part and then compare its effectiveness and safety to standard treatment in the Phase III part in participants who have not received prior endocrine therapy in the advanced setting. In the Phase Ib portion, participants receive capivasertib combined with one of the CDK46 inhibitorspalbociclib, ribociclib, or abemacicliband fulvestrant to establish recommended doses. In the Phase III part, participants are randomly assigned to receive either capivasertib plus fulvestrant with a chosen CDK46 inhibitor palbociclib or ribociclib or fulvestrant with a CDK46 inhibitor alone. Treatments are given in 28-day cycles with specific dosing schedules for each drug, including oral doses of capivasertib and CDK46 inhibitors and injections of fulvestrant. Participants undergo screening and regular monitoring throughout the study, including assessments of treatment side effects, tumor progression, and blood samples for pharmacokinetics and biomarker analysis. The primary outcomes include dose-limiting toxicities and adverse events in Phase Ib and progression-free survival in Phase III, with follow-up lasting up to several years to evaluate overall survival, response rates, physical functioning, and quality of life.

Researchers are conducting a combined Phase 2b and Phase 3 clinical trial to study CSL300 Clazakizumab in adults with end stage kidney disease ESKD who are undergoing maintenance dialysis. The study aims to find the right dose of CSL300 and then evaluate its effect on cardiovascular outcomes and safety in people with systemic inflammation and either atherosclerotic cardiovascular disease ASCVD or diabetes. This is a randomized, double-blind, placebo-controlled study involving multiple centers. Participants will receive intravenous IV administration of either CSL300 or a placebo. The Phase 2b part focuses on determining the appropriate dose of CSL300 compared to placebo over about 12 weeks, while the Phase 3 part examines CSL300s effect on cardiovascular events over approximately five years. The study includes different dosing groups in Phase 2b and a larger comparison of CSL300 versus placebo in Phase 3. During the study, participants will be monitored regularly with blood tests that measure inflammation markers such as high-sensitivity C-reactive protein hs-CRP, cardiovascular events, and safety outcomes. Researchers will track changes in various blood components and adverse events up to 32 weeks in Phase 2b and follow cardiovascular outcomes for up to five years in Phase 3. The total participation lasts through these periods with scheduled assessments to evaluate treatment effects and safety.

Researchers are evaluating DCSZ11, a monoclonal antibody, as a treatment for patients with advanced or metastatic solid tumors. This Phase 1, multicenter, open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential antitumor activity of DCSZ11 both alone and in combination with pembrolizumab. The study includes patients who have relapsed or refractory tumors and have limited or no effective standard therapy options. The study has two main phases Phase 1a Dose Escalation and Phase 1b Dose ExpansionOptimization. In Phase 1a, patients receive intravenous infusions of DCSZ11 every 3 weeks either as monotherapy or combined with pembrolizumab, with doses increased to find the maximum tolerated or planned dose. Phase 1b evaluates DCSZ11 combined with pembrolizumab or standard-of-care treatments like doxorubicin for soft tissue sarcoma and tebentafusp for uveal melanoma, using designs to optimize dosing and monitor safety continuously. Participants will undergo screening that includes biopsies, imaging, and laboratory tests to confirm eligibility and monitor response. Researchers will evaluate tumor response using established criteria such as RECIST and iRECIST over one year, and follow safety and survival outcomes for up to three years. The study involves regular clinic visits, safety assessments, and monitoring for immune responses and drug levels to understand treatment effects and tolerability.

Researchers are evaluating the preliminary efficacy, safety, and population pharmacokinetics PopPK of ABP-745 in adults aged 18 to 75 years who have atherosclerotic cardiovascular disease ASCVD. This randomized, double-blind, placebo-controlled Phase II study aims to compare the ability of ABP-745 to reduce atherosclerotic plaque against a placebo. The primary measurement of efficacy will be the change in percent atheroma volume PAV after 52 weeks of treatment. Participants will be randomly assigned to one of four groups placebo or one of three different doses of ABP-745 tablets taken orally once daily. Throughout the study, existing lipid-lowering maintenance medications will remain unchanged. The study includes a 52-week treatment period, after which the primary outcome will be assessed. Safety and tolerability will also be monitored up to 14 days after the last dose. During the study, participants will continue their current oral lipid-lowering therapy and attend regular visits for assessments including physical exams, vital signs, laboratory tests, and ECGs. Researchers will measure changes in atherosclerotic plaque volume and monitor for adverse events. The total duration of participation includes the 52-week treatment period plus safety follow-up, with detailed monitoring to evaluate the impact and safety of ABP-745 in this population.

Researchers are evaluating the safety and effectiveness of intravesical administration of detalimogene EG-70, a novel non-viral gene therapy, in patients with non-muscle invasive bladder cancer NMIBC. The study focuses on patients with carcinoma in situ CIS unresponsive to BCG therapy and other high-risk NMIBC patients, including those who are BCG-nafve or incompletely treated. The trial includes a Phase 1 dose-escalation to determine safety and recommended dose, followed by a Phase 2 to assess treatment effectiveness. Participants will receive EG-70 via bladder instillation with a catheter in cycles lasting about 12 weeks. Phase 1 involves up to four cycles with either two or four doses per cycle, aiming for a 60-minute retention time. Phase 2 participants receive four instillations per cycle for up to four cycles at the recommended dose. Those achieving complete response may continue with maintenance treatment involving two doses per 12-week cycle. A substudy includes a surfactant bladder rinse before EG-70 instillation, with a shortened administration time. During the study, participants undergo regular assessments including cystoscopy, urine cytology, and biopsies to monitor response and safety. Researchers track adverse events, treatment response rates, duration of response, progression-free survival, and quality of life over periods ranging from weeks to years. Safety monitoring follows standardized criteria, and participants may continue in maintenance cycles if responding. The total study duration extends up to approximately nine years from start to completion.

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called N-3C01, given by subcutaneous injection alone or combined with a PD-L1 monoclonal antibody, in adults with advanced solid tumors. This Phase III study includes a dose escalation phase for both the single drug and the combination, followed by an expansion phase focusing on the combination therapy in selected patient groups. In Phase I, participants receive N-3C01 either alone or together with a fixed dose of PD-L1 antibody, to find the maximum tolerated dose and the recommended dose for Phase II. The drug is given by subcutaneous injection every 2 or 3 weeks. In Phase II, participants receive the recommended dose of N-3C01 combined with the PD-L1 antibody. One treatment option includes pembrolizumab administered intravenously every 3 weeks alongside N-3C01. Participants will be closely monitored for safety throughout the study, including evaluation of toxicities, adverse events, vital signs, ECGs, blood and urine tests, and thyroid function, up to about 24 months. Researchers will also assess how the body processes the drug, immune responses, tumor response, progression-free survival, and overall survival. Study visits and safety follow-up will continue for up to two years after treatment begins to ensure thorough observation.