Kashiwa

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are studying KK2260 in patients with advanced or metastatic solid tumors to evaluate its safety, tolerability, and effectiveness. This is a first-in-human, phase 1 clinical trial that aims to determine the maximum tolerated dose MTD and assess different dosing regimens. The study focuses on patients with various solid tumors, including esophageal squamous cell carcinoma and head and neck squamous cell carcinoma. KK2260 will be given intravenously at several dose levels. In Part 1a, the maximum tolerated dose will be identified while monitoring safety. Parts 1b and 2 will test at least two dosing regimens for different cancer types to evaluate the safety, tolerability, and efficacy of each regimen. The study is open-label, non-randomized in early parts, and randomized in the later part, with participants assigned to different dosing groups. Participants will undergo weekly laboratory tests for blood counts, liver and kidney function, and other measures for about one year. Researchers will monitor adverse events, vital signs, ECG parameters, and performance status regularly. Various outcomes such as dose-limiting toxicity, overall response rate, progression-free survival, and overall survival will be tracked during treatment and follow-up. The study includes tumor biopsies before and after treatment. The total duration of involvement may last around one year or more depending on treatment and follow-up.

Researchers are investigating whether sacituzumab tirumotecan alone or combined with other treatments can treat certain advanced or unresectable gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and how well the cancer responds to these treatments. Participants will receive sacituzumab tirumotecan in different dose levels either combined with chemotherapy every two weeks in a 4-week cycle, alone every two weeks in a 4-week cycle, or combined with cisplatin and pembrolizumab in a 3-week cycle. Treatment continues until the cancer worsens or participants cannot tolerate it. Cisplatin is given up to approximately six months, and pembrolizumab is administered for up to about two years in the combination group. During the study, participants will have regular assessments to monitor safety, side effects, and how the cancer responds via imaging and clinical evaluation. Researchers will track dose-limiting toxicities, adverse events, treatment discontinuations due to side effects, and objective response rates. Additional measures include duration of response, progression-free survival, and overall survival, with monitoring lasting up to approximately 63 months.

Researchers are evaluating the clinical effectiveness of Serplulimab HLX10 combined with Bevacizumab and chemotherapy XELOX compared to a placebo combined with Bevacizumab and XELOX chemotherapy in treating patients with metastatic colorectal cancer mCRC who have not previously received systemic treatment for metastatic or recurrent disease. This phase IIIII randomized, double-blind, multicenter study aims to assess how well these treatments work as a first-line therapy in this patient group. The study includes a safety run-in period enrolling 6-12 patients, followed by a phase II study with about 100 patients split evenly between treatment and control groups, and a larger phase III study involving approximately 568 patients across multiple countries. Participants receive either Serplulimab at a fixed 300 mg dose intravenously every three weeks plus Bevacizumab 7.5 mgkg IV every three weeks and XELOX chemotherapy, or placebo plus Bevacizumab and XELOX chemotherapy. The treatment period consists of 3-week cycles lasting up to two years. Participants will undergo a screening period up to 28 days before treatment, followed by treatment cycles and a follow-up phase including safety monitoring and survival checks every 12 weeks. Researchers will evaluate progression-free survival as the primary outcome, along with other measures such as overall survival, response rates, and disease control. Assessments will include tumor measurements, gene testing from tumor tissue, and monitoring of organ function and performance status throughout the study.

Researchers are evaluating new treatment combinations involving BNT314 and pumitamig alongside chemotherapy in people with metastatic colorectal cancer mCRC that is microsatellite stable or mismatch repair proficient. This study includes three parts Part A focuses on safety and dose escalation of BNT314 with pumitamig Part B assesses safety and dosing of BNT314 combined with pumitamig and standard chemotherapy in treatment-nafve or previously treated patients Part C tests effectiveness of these combinations compared to usual chemotherapy treatments. The study aims to see if these treatments can shrink tumors or slow cancer growth. Participants receive intravenous infusions of BNT314 and pumitamig, along with standard of care SoC chemotherapy, in various dose levels and combinations depending on the study part. Part A evaluates up to five dose levels of BNT314 and one or two doses of pumitamig. Part B uses optimized doses of BNT314 with pumitamig and one of two chemotherapy regimens. Part C compares the recommended BNT314 and pumitamig doses plus chemotherapy against other treatment combinations, including bevacizumab with chemotherapy or pumitamig with chemotherapy. Treatment continues until disease progression, intolerance, withdrawal, or study end. Participants undergo eligibility screening, then receive treatment for an average of 6 to 10 months. They are regularly monitored for safety and treatment effects, including tumor response and side effects, with assessments extending up to 57 months after starting treatment. After treatment ends, participants enter safety follow-up and long-term survival monitoring to track any lasting effects and overall outcomes. Randomization is used in Parts B and C to assign treatments by chance.

Researchers are evaluating BGB-16673, an oral drug, in adults with various types of B-cell malignancies such as marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenstrm macroglobulinemia, diffuse large B-cell lymphoma, and Richters transformation. This study includes Phase 1 dose finding and safety expansion, followed by Phase 2 expansion cohorts to determine recommended doses and further assess safety and efficacy. The study is divided into several parts, starting with Phase 1 dose escalation to find safe dosage levels, including monotherapy dose escalation and safety expansion in selected doses. Phase 2 involves expansion cohorts where participants receive the recommended doses identified in Phase 1 for further safety and efficacy evaluation. Some cohorts include participants who have not received prior BTK inhibitors, and Japanese participants are also enrolled to assess safety. Treatments are orally administered. Participants will undergo regular assessments including monitoring for adverse events, disease response, and drug concentration levels in the blood at various time points. Researchers will measure outcomes such as overall response rate and progression-free survival over approximately three years. Safety and tolerability will be closely tracked, and quality of life questionnaires will be completed at scheduled intervals. Participation may last several years, including follow-up periods to monitor long-term effects.

Researchers are evaluating the safety and early effectiveness of SAR445877, a new drug given alone or with other cancer treatments, in adults aged 18 and older who have advanced solid tumors that cannot be surgically removed or have spread. This Phase 12 open-label study includes participants who have limited or no standard treatment options, aiming to find the best dose and assess how well SAR445877 works in different combinations. The study has two parts Part 1 focuses on gradually increasing doses of SAR445877 given intravenously every one or two weeks to find safe and effective doses alone or with other therapies like cetuximab, ADG126, or bevacizumab. Part 2 expands to multiple groups testing SAR445877 at recommended doses, either alone or combined with these other anticancer drugs, in various cancer types such as melanoma, non-small cell lung cancer, colorectal, gastric, and liver cancers. Participants undergo a screening period of up to 28 days before starting treatment, which continues until the cancer progresses, unacceptable side effects occur, or other reasons require stopping. After treatment ends, there is a follow-up period to monitor outcomes until disease progression, new therapy, death, or withdrawal. Throughout the study, researchers collect safety data, tumor response measures, drug levels in the body, and immune responses to evaluate the effects of SAR445877 and combinations for up to two years.

Researchers are evaluating the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma LA-HNSCC who have not progressed after receiving definitive concurrent chemoradiotherapy cCRT. This phase III, randomized, open-label global study aims to assess whether volrustomig can improve outcomes in this patient population. Participants are randomly assigned to one of two groups those who receive volrustomig as sequential therapy, and those who undergo observation without additional treatment. The study compares these two approaches following prior curative concurrent chemoradiotherapy. The trial includes long-term follow-up to monitor patient outcomes. During the study, participants will be regularly assessed for progression-free survival, overall survival, physical functioning, and quality of life. Researchers will also monitor for the presence of anti-drug antibodies and adverse events related to volrustomig. Follow-up evaluations may continue for up to approximately eight years to fully understand the treatment impact and safety profile.

Researchers are evaluating the long-term effects of mirikizumab treatment in children and teenagers aged 2 to 19 years with moderate-to-severe ulcerative colitis or Crohns disease. This phase 3 study aims to assess the clinical remission rates and other health outcomes related to these conditions over an extended period. The study is sponsored by Eli Lilly and Company and follows a treatment focus for pediatric participants with these inflammatory bowel diseases. Participants receive mirikizumab administered by subcutaneous injections, with doses adjusted based on their weight. There are up to six planned doses, and if needed, intravenous rescue dosing is available if a participants condition worsens. The study may include a continued access period providing additional treatment beyond the main study duration. Participants are involved for about 172 weeks, attending up to 44 visits throughout the study. Regular assessments include evaluating clinical remission using the Modified Mayo Score for ulcerative colitis and the Pediatric Crohns Disease Activity Index for Crohns disease, along with other response and remission measures. Researchers monitor laboratory tests such as C-reactive protein levels and track corticosteroid use. Safety and health status are closely observed during the study and any continued treatment periods.

Researchers are evaluating BMS-986500 as a treatment for people with advanced solid tumors, including advanced breast and ovarian cancers. This Phase 1 study investigates BMS-986500 alone and in combination with other drugs in patients who have previously been treated with CDK46 inhibitors for breast cancer. The study aims to understand how this drug works and its safety for these advanced cancers. Participants receive BMS-986500 either as a single drug or combined with Palbociclib and Fulvestrant, with doses given on specified days. The study includes multiple parts dose escalation for both monotherapy and combination therapy, a pharmacodynamic sub-study for monotherapy, and dose expansion phases for both treatment types. Each part explores different dosing strategies and treatment effects. During the study, participants are closely monitored for side effects, including dose-limiting toxicities and serious adverse events up to 28 days after the last dose. Blood tests measure how the drug is processed in the body over about two years. The study tracks safety and drug levels while participants receive treatment and during follow-up, with the study lasting until 2028. Participants undergo assessments for disease status and overall health throughout the trial.