Kashiwa

Researchers are evaluating new treatment options for adults with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This study compares the safety and effectiveness of adding calderasib and cetuximab, both targeted therapies, to a standard chemotherapy regimen called mFOLFOX6. The goal is to see if this combination can help patients live longer without their cancer growing or spreading compared to current treatments that may include mFOLFOX6 with or without bevacizumab. The study has two parts. It involves treatment with calderasib taken as an oral tablet, cetuximab given according to standard procedures, and mFOLFOX6 chemotherapy combining oxaliplatin, leucovorin/levofolinate calcium, and 5-fluorouracil. Some participants may receive bevacizumab or a bevacizumab biosimilar as part of the comparison. The treatments are given following approved dosing schedules. This design allows researchers to assess the safety and tolerability of these drug combinations in treating this type of colorectal cancer with the KRAS G12C mutation. Participants will be monitored for side effects, treatment tolerability, and cancer progression over a period that may last up to about 44 months. Researchers will track outcomes such as how many participants experience dose-limiting toxicities or adverse events, how many stop treatment due to side effects, and progression-free survival time. Assessments include health evaluations, laboratory tests, and imaging to observe cancer status. This long-term follow-up aims to understand both safety and effectiveness of the treatment combinations.

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.

Researchers are investigating sacituzumab tirumotecan (MK-2870) alone or combined with other treatments to treat certain gastrointestinal cancers. These include colorectal cancer that cannot be removed by surgery or has spread, advanced pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and measure how many participants respond to the treatment by having their cancer shrink or disappear. Participants may receive sacituzumab tirumotecan by intravenous infusion alone or with other anticancer drugs such as fluorouracil (5-FU), leucovorin or levoleucovorin, cisplatin, and pembrolizumab. Rescue medications like diphenhydramine, H2 receptor antagonists, acetaminophen, dexamethasone, and a steroid mouthwash are given to prevent infusion reactions and oral side effects. Supportive care treatments for side effects, including antidiarrheal and antiemetic agents, are allowed throughout the study. During the study, researchers monitor participants for dose-limiting toxicities within about 4 weeks and track adverse events, treatment discontinuations, and tumor response over up to approximately 63 months. Assessments include safety evaluations and measuring cancer response using standardized criteria. This long-term follow-up helps evaluate both the effectiveness and safety of the treatments being studied.

Researchers are evaluating the clinical effectiveness of Serplulimab (HLX10) combined with Bevacizumab and chemotherapy (XELOX) compared to a placebo combined with Bevacizumab and chemotherapy (XELOX) for patients with metastatic colorectal cancer (mCRC). This is a randomized, double-blinded, multicenter phase II/III study including patients with unresectable metastatic or recurrent colorectal adenocarcinoma who have not yet received systemic treatment for these metastatic or recurrent lesions. The study involves multiple centers across China, Japan, and Indonesia and aims to assess progression-free survival up to 100 months. The study includes a safety run-in period with 6-12 patients, followed by a phase II study enrolling about 100 patients, and a phase III study with approximately 568 patients. Treatments involve intravenous infusions of Serplulimab at a fixed dose of 300 mg every three weeks and Bevacizumab at 7.5 mg/kg every three weeks, combined with chemotherapy. Participants undergo a screening period of up to 28 days, followed by a treatment period consisting of 3-week cycles for up to two years, and then enter a follow-up period that includes safety monitoring and survival assessments every 12 weeks. During the study, participants will be regularly assessed through measurable lesion evaluation, tumor tissue collection for gene testing, and ECOG performance status monitoring. Researchers will track progression-free survival from randomization until disease progression or death. Safety and organ function will also be monitored throughout the treatment and follow-up periods. The study requires participants to have adequate organ function and an ECOG score of 0 or 1 before starting treatment, with ongoing safety evaluations during and after therapy.

Researchers are evaluating the safety and effectiveness of new treatments called BNT314 and BNT327 combined with chemotherapy for people with metastatic colorectal cancer (mCRC) that is microsatellite stable or mismatch repair proficient (MSS/pMMR). This study includes participants who did not respond well to their first chemotherapy treatment and aims to find the right dose and assess how well these treatments work together to shrink tumors or slow their growth. The study includes multiple phases to test safety, dosing, and treatment benefits. The study has three parts: Part A focuses on safety and dose escalation of BNT314 with BNT327; Part B tests the safety and optimal dose of BNT314 combined with BNT327 and standard chemotherapy; and Part C compares the combination treatment with standard chemotherapy alone to see if it improves outcomes. Treatments are given by intravenous infusion or oral methods depending on the drug. Participants receive treatment until their disease worsens, they cannot tolerate the therapy, or the study ends, with an average treatment duration of 6 to 10 months. Participants will be screened, treated, and followed up for safety and long-term survival. Researchers will regularly monitor for side effects, treatment response, and disease progression using scans and laboratory tests. The study includes a safety follow-up period and a long-term survival follow-up that can last up to 57 months, with committees overseeing participant safety throughout the trial.

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Researchers are studying BAY 3713372, a new drug being developed to treat solid tumors with a specific genetic change called MTAP deletion. The drug works by blocking a protein called PRMT5, which may kill cancer cells with this deletion while sparing normal cells. This first-in-human study aims to understand the safety, how the body processes the drug, and its effectiveness in people with these MTAP-deleted solid tumors. Participants will receive BAY 3713372 orally every day. The study starts with a dose escalation phase, where different groups get increasing doses to find a safe and effective dose. After this, a dose expansion phase will include more participants receiving the drug alone or with other treatments. Participants can continue treatment as long as they benefit and do not experience severe problems. During the study, participants will visit the study site multiple times before and during treatment, and follow-up visits after treatment ends. Doctors will monitor health through blood and urine tests, heart checks with electrocardiograms, and imaging scans like CT or MRI to track cancer changes. Tumor samples may also be taken. Safety and treatment response will be closely assessed, including adverse events and how the drug behaves in the body. Participants will be contacted every three months for up to two years after treatment to check their health.

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

This research investigates the long-term effects of mirikizumab in children and adolescents aged 2 to 19 years with moderate-to-severe ulcerative colitis or Crohn's disease. The study is designed as a Phase 3, multicenter, open-label extension trial aiming to assess the ongoing safety and efficacy of this treatment in pediatric participants. It includes those who have completed previous related studies and are expected to benefit from continued mirikizumab treatment. Participants will receive mirikizumab either by subcutaneous injection or intravenous infusion as part of this extended treatment. The study may last approximately 172 weeks and involve up to 44 visits over this period. There is also a possibility for participants to continue receiving treatment through a Continued Access Period after the main study. Throughout the study, participants will be regularly monitored with clinical assessments to determine remission status using the Modified Mayo Score for ulcerative colitis and the Pediatric Crohn's Disease Activity Index for Crohn's disease at week 52. Safety and efficacy will be closely followed, including the evaluation of any adverse events or changes in disease activity, ensuring comprehensive long-term observation.

Researchers are evaluating BMS-986500 as a treatment for people with advanced solid tumors and those with advanced breast cancer previously treated with CDK4/6 inhibitors. This phase 1 study aims to assess BMS-986500 alone and in combination with other therapies, focusing on its safety and tolerability in these patient groups. Participants will receive BMS-986500 either by itself or combined with palbociclib and fulvestrant at specified doses on designated days. The study includes a group with advanced solid tumors and a subgroup with CCNE1-amplified ovarian cancer for specific evaluation. Treatment schedules and doses are defined according to the study protocol. During the study, researchers will monitor participants for dose-limiting toxicities, adverse events, serious adverse events, treatment-related events leading to discontinuation, and those resulting in death, all assessed up to 28 days after the last dose. Participants will undergo disease evaluations and performance status assessments to track treatment effects and safety throughout the study period.