Ina

Researchers are evaluating KK2260 in patients with advanced or metastatic solid tumors in a Phase 1 clinical trial. The study aims to find the maximum tolerated dose (MTD) and assess the safety, tolerability, and effectiveness of KK2260 across multiple cancer types, including esophageal and head and neck cancers. The study includes initial dose escalation followed by evaluations of different dosing regimens tailored by cancer type. KK2260 is given through an intravenous infusion at various dose levels. The study is divided into parts: Part 1a focuses on finding the MTD while monitoring safety; Part 1b and Part 2 involve testing selected dosing regimens in specific cancers. Participants may undergo tumor biopsies before and after treatment to help assess the drug's effects. Participants will be closely monitored for safety and treatment effects for about one year. This includes regular blood tests every week to check many laboratory values such as blood cell counts, liver and kidney function, electrolytes, and immune markers. Vital signs, electrocardiograms, and performance status will also be tracked weekly. Researchers will record any side effects and dose-limiting toxicities. The thorough monitoring helps understand KK2260's impact over time and supports participant safety throughout the study.

This research aims to evaluate the tolerability and safety of ONO-7428 in adults with unresectable advanced or recurrent solid tumors, including non-small cell lung cancer (NSCLC). The study focuses on participants who have tumors resistant or intolerant to standard treatments and who have previously received anti-PD-(L)1 antibody therapies. It is a Phase 1, open-label, dose-escalation study designed to understand how well participants tolerate ONO-7428 and to monitor its safety profile. Participants will receive specified doses of ONO-7428 on designated days as part of the treatment protocol. The study includes a backfill cohort specifically for those with advanced or recurrent NSCLC as classified by the UICC-TNM system. The dosing schedule and escalation allow researchers to identify dose-limiting toxicities and monitor adverse events over an extended period. During the study, participants will be closely monitored for dose-limiting toxicities within the first 21 days and adverse events for up to two years. Researchers will collect tumor tissue samples for biomarker testing and assess participants’ performance status. The study involves ongoing safety assessments and long-term follow-up to better understand the effects and risks associated with ONO-7428 treatment.

Researchers are evaluating the effectiveness, safety, optimal dosing, and immune response development of TRK-950 combined with ramucirumab and paclitaxel compared to ramucirumab and paclitaxel alone in people with gastric or gastro-esophageal junction (GEJ) adenocarcinoma. This phase 2 study aims to improve progression-free survival and also looks at overall survival, response rates, and disease control in participants with these cancers. Participants receive TRK-950 at two dose levels (5 mg/kg or 10 mg/kg) given by IV infusion over 60 minutes on Days 1, 8, 15, and 21 of each 28-day cycle. Ramucirumab (8 mg/kg IV) is given on Days 1 and 15, and paclitaxel (80 mg/m² IV) is administered on Days 1, 8, and 15 of each 28-day cycle. The study compares the combination treatment to ramucirumab plus paclitaxel alone. During the study, participants undergo regular assessments including CT scans to measure disease progression, laboratory tests to monitor organ function and immune response, and evaluations of overall health and symptoms. The main outcome measured is progression-free survival up to about 24 months. Safety and treatment effects are closely monitored throughout participation, with informed consent and tissue testing required before enrollment.

Researchers are evaluating the effectiveness and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This Phase 3 study focuses on individuals aged 60 to 85 who have a confirmed diagnosis of Alzheimer's disease according to updated clinical criteria and have specific cognitive scores indicating mild to moderate dementia. Participants will receive either the study drugs KarXT and KarX-EC or a placebo, each given at specified doses on certain days. The study is randomized, double-blind, and placebo-controlled to compare the effects of these treatments on cognitive function. Those already taking certain Alzheimer's medications must have stable doses before and during the study. During the study, participants and their caregivers will attend multiple visits where cognitive assessments and interviews will be performed. Key measures include changes in a cognitive scale (ADAS-Cog11) and clinical impressions of improvement at 24 weeks. Caregivers play an important role by providing information, ensuring medication adherence, and participating in study activities. Safety and treatment effects will be carefully monitored throughout the trial.

Researchers are evaluating the overall survival of women with stage I epithelial ovarian cancer following comprehensive staging surgery. This phase III trial compares the effects of adjuvant chemotherapy versus observation without chemotherapy in this patient group. Patients are randomly assigned based on histologic type, enrollment facility, and clinical staging according to the FIGO system. Participants are divided into two groups. Group A receives adjuvant chemotherapy, which includes either Paclitaxel plus Carboplatin or Docetaxel plus Carboplatin, administered every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. Group B undergoes observation only, with no chemotherapy given. The study treatment starts within eight weeks after comprehensive staging surgery. During the study, participants undergo regular assessments to monitor survival status up to 60 months from randomization. Researchers collect data including clinical evaluations, imaging, and laboratory tests as needed. Safety is closely monitored, and participants provide informed consent before enrollment. The trial aims to determine whether adjuvant chemotherapy improves survival compared to observation alone in this patient population.