Osakasayama

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are conducting a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab with investigator's choice monotherapy in patients with head and neck squamous cell carcinoma (HNSCC) who have incurable metastatic or recurrent disease. This study focuses on patients with progressive disease after anti-PD-1 therapy and platinum-containing therapy and aims to evaluate the treatments as second- or third-line options. Participants will receive either petosemtamab or one of the investigator's choice monotherapies, including cetuximab, methotrexate, or docetaxel. The study involves treatment administration under controlled conditions with monitoring for efficacy and safety. The goal is to assess the treatments over time with a focus on response rates and overall survival. During the study, participants will undergo regular assessments including radiologic imaging to measure tumor response, and evaluations of overall survival up to approximately three years. The primary outcomes include objective response rate assessed by blinded independent central review and overall survival. Researchers will monitor patient health, side effects, and treatment effectiveness throughout the study duration.

Researchers are evaluating the safety and effectiveness of combining petosemtamab with pembrolizumab compared to pembrolizumab alone as a first treatment for people with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (HNSCC). This Phase 3, randomized, open-label study focuses on patients who have not received previous systemic therapy for incurable recurrent or metastatic disease, though prior therapy for locally advanced disease is allowed under certain conditions. The study excludes patients who have been treated with anti PD-(L)1 or anti-EGFR therapies except in specific cases. Participants will receive either the combination of petosemtamab plus pembrolizumab or pembrolizumab alone as their first-line treatment for this condition. The study includes detailed eligibility criteria based on tumor location, PD-L1 expression, health status, and prior treatments. Treatment effects will be observed over time with a focus on overall survival and tumor response rates measured according to standard criteria. During the study, participants will undergo assessments including tumor biopsies, imaging scans to measure disease progression, heart function tests, and evaluations of organ function. Safety and treatment response will be closely monitored up to approximately three years. The study also tracks overall survival and tumor response rate as primary outcomes, ensuring continuous follow-up and support throughout the trial period.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are evaluating the safety and tolerability of ASP3082 in adults with advanced solid tumors that have a specific KRAS G12D mutation. This open-label Phase 1 study includes patients with locally advanced or metastatic solid tumors who have received prior standard therapies or are ineligible for them. The study is conducted in two parts to identify suitable doses of ASP3082 alone or combined with cetuximab. In Part 1, small groups of participants receive escalating doses of ASP3082 alone or with cetuximab through intravenous infusion. A medical panel reviews safety data after each group to decide on dose escalation. In Part 2, participants receive ASP3082 alone or with other study treatments, including various chemotherapy drugs, also by infusion. Treatments are given in cycles lasting 21 or 28 days and continue until intolerable side effects, disease progression, new treatments, or participant withdrawal. Participants will undergo regular assessments including physical exams, laboratory tests, ECGs, and performance status evaluations to monitor safety and treatment effects for up to 48 months. Researchers will track adverse events, dose-limiting toxicities, and overall health status throughout the study. Participants must provide tumor samples and may have biopsies during treatment. The study involves ongoing monitoring to assess the impact and safety of ASP3082 over time.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) combined with the immune checkpoint inhibitor atezolizumab, with or without carboplatin, in adults with extensive stage-small cell lung cancer (ES-SCLC). This study includes two parts: Part A, a Phase 1b safety run-in phase, and Part B, a Phase 2 dose optimization phase. The main goal is to assess treatment-related side effects and determine the best dose of I-DXd in these combination therapies for first-line treatment. The study has two cohorts: Cohort 1 includes participants receiving I-DXd as maintenance therapy after initial induction treatment with carboplatin, etoposide, and atezolizumab; Cohort 2 includes participants receiving I-DXd during both induction and maintenance phases without prior ES-SCLC treatment. All study drugs, including I-DXd, atezolizumab, and carboplatin, are given intravenously. Participants will receive treatments in cycles of 21 days, with specific dosing and combination regimens evaluated during the study. Participants will undergo regular assessments including monitoring for dose-limiting toxicities and any treatment-emergent adverse events from the start of treatment up to 37 months. Safety evaluations, laboratory tests, imaging, and other study procedures will be conducted according to the protocol. The study aims to closely observe how participants tolerate the treatments and to collect important data on side effects and overall safety throughout the study period.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) in adults with advanced or metastatic esophageal squamous cell carcinoma (ESCC) that cannot be surgically removed. The study focuses on patients whose disease has worsened after receiving platinum-based chemotherapy and an immune checkpoint inhibitor. This phase 3 trial compares I-DXd to chemotherapy chosen by the doctor to see which treatment helps patients live longer. Participants receive either I-DXd or one of several chemotherapy drugs, including docetaxel, paclitaxel, or irinotecan hydrochloride, all given through intravenous infusion. The goal is to assess overall survival, progression-free survival, and objective response rate. The study includes a randomized, open-label design across multiple centers. During the trial, participants are monitored regularly with scans, imaging, and clinical assessments to measure tumor response and disease progression. Researchers will track overall survival from the time of randomization up to about 54 months. Safety is closely observed throughout the study. Participants must provide tumor samples before starting treatment and have measurable lesions suitable for evaluation. The study requires an Eastern Cooperative Oncology Group performance status of 0 or 1 at baseline and includes detailed eligibility and exclusion conditions to ensure safety and appropriate selection.

Researchers are evaluating the safety, tolerability, and effectiveness of valemetostat tosylate combined with DXd antibody-drug conjugates (ADCs) in patients with advanced solid tumors, including HER2-positive gastric cancer, non-squamous non-small cell lung cancer (NSCLC), and unresectable or metastatic HER2 low breast cancer. This Phase 1b study aims to determine the recommended dose for further study and to assess treatment effects in these patient groups. The study has two parts: Part 1 involves dose escalation where valemetostat is given orally once daily, combined with either T-DXd or Dato-DXd administered by intravenous infusion every three weeks on Day 1 of each 21-day cycle. After identifying the recommended dose, Part 2 will expand to further evaluate safety and tolerability of this combination treatment. Participants will undergo regular assessments including imaging scans every 6 weeks during the first year and every 12 weeks thereafter to evaluate tumor response. Safety will be monitored from screening through 40 days after the last dose. Researchers will track adverse events and dose-limiting toxicities during the treatment cycles, which last 21 days each. Follow-up may continue for up to approximately 5 years to observe long-term outcomes.

Researchers are evaluating how well vortioxetine tablets at doses of 10 mg/day or 20 mg/day work compared to placebo tablets for treating depression symptoms in Japanese teenagers aged 12 to 17 years who have been diagnosed with Major Depressive Disorder (MDD). This phase 3 clinical trial aims to assess the drug's effectiveness, safety, and how the body processes the medication in this pediatric population. Participants will be randomly assigned to receive either vortioxetine or a placebo once daily for 14 weeks. The study includes an initial screening period of up to 15 days to determine eligibility, followed by the 14-week treatment phase. After completing treatment, there is a 4-week period dedicated to monitoring any side effects. Throughout the study, participants will visit the clinic 13 times for assessments and medication administration. During the study, participants will undergo evaluations including the Children Depression Rating Scale Revised version (CDRS-R) to measure changes in depression symptoms from baseline to week 14. Other assessments include safety monitoring and pharmacokinetics. Researchers will also collect information on side effects during and after treatment. The total time commitment for participants is about 20 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating the safety, effectiveness, and how the body processes zipalertinib in adults with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that has specific mutations in the Epidermal Growth Factor Receptor (EGFR) gene, including exon 20 insertions and other uncommon mutations. This Phase 2b study also explores potential drug interactions of zipalertinib with certain enzyme and transporter substrates and aims to find the best dosing plan for the medication. Participants will be enrolled into one of four main groups based on their specific EGFR mutation status and treatment history. These groups include those previously treated with exon 20 insertion agents, those untreated and unsuitable for standard chemotherapy, those with active brain metastases or leptomeningeal disease, and those with other uncommon EGFR mutations without prior systemic therapy. Additionally, separate substudies will assess drug interactions using enzyme and transporter probe cocktails and will test different doses of zipalertinib in randomized groups until treatment discontinuation. Throughout the study, participants will undergo regular assessments including imaging scans, neurological exams, and laboratory tests to monitor disease progression and treatment safety. Researchers will track response rates over up to two years and evaluate brain metastasis stability when applicable. Safety monitoring, including cardiac function and adverse effects, will be ongoing. The study requires tissue samples to confirm mutation status and participants will be followed closely to evaluate the medication's impact and tolerability.