Chuo City

Researchers are evaluating calderasib alone or combined with cetuximab to treat people with advanced solid tumors that have the KRAS G12C mutation, excluding colorectal cancer. This study aims to measure how many participants experience tumor shrinkage or disappearance and compare the responses between the two treatments. It is a phase 2, open-label trial focused on treatment safety and tolerability. Participants will receive calderasib orally with no set limit on treatment cycles. Some participants will also receive cetuximab via intravenous infusion every two weeks. Treatment continues until criteria for stopping the study intervention are met. The trial uses a randomized, parallel design to compare the two experimental arms. Throughout the study, participants will be monitored for tumor response, adverse events, and treatment discontinuations related to side effects. Researchers will also assess progression-free survival, duration of response, and overall survival up to about 76 months. The trial lasts until April 2032, with ongoing safety and efficacy evaluations during this period.

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 new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a condition characterized by skin thickening and other systemic symptoms. This Phase 2 study compares ianalumab to a placebo to understand its impact on this disease, aiming to provide new treatment options for affected individuals. The study is sponsored by Novartis Pharmaceuticals and employs a randomized, double-blind design to ensure reliable results. Participants receive either ianalumab or placebo through subcutaneous injections during the initial 52-week treatment period. After this, all participants enter a second 52-week open-label phase where they receive ianalumab. Following treatment, there is a post-treatment follow-up lasting at least 20 weeks and up to 2 years to monitor long-term effects. The study includes a screening period lasting up to 6 weeks before treatment begins. Throughout the study, participants undergo regular assessments including measuring response based on the rCRISS25 scale at Week 52, lung function tests, skin scoring, and disability index evaluations. Blood samples are taken periodically to measure drug levels and antibodies. Safety is closely monitored through adverse event reporting up to Week 208. The total participation time can extend over several years including treatment and follow-up phases.

Researchers are evaluating if ifinatamab deruxtecan I-DXd, an antibody-drug conjugate, can treat advanced esophageal squamous cell carcinoma ESCC. This treatment works by attaching to proteins on cancer cells and delivering therapy to destroy them. The study aims to find out how many participants experience tumor shrinkage or disappearance after receiving I-DXd. Participants will receive I-DXd through intravenous infusion every 3 weeks. Treatment continues until the cancer progresses or other criteria for stopping are met. The study is part of a master screening protocol called KEYMAKER-U06 and focuses on participants with unresectable locally advanced or metastatic ESCC who have had prior systemic therapy. During the study, participants will be monitored for tumor response using objective response rate over about 14 months. Researchers will also measure duration of response, progression-free survival, overall survival, and track adverse events for up to 18 to 26 months. Participants undergo regular assessments including imaging and safety evaluations throughout their participation, which may last several months.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in people with Sjgrens Syndrome. This phase 3 open-label study extends previous trials by continuing to monitor participants who completed 48 weeks of treatment with dazodalibep or placebo. The study is sponsored by Amgen and aims to better understand the safety profile of dazodalibep over an extended period. Participants who finished the initial 48-week trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive an assigned dose of dazodalibep intravenously for an additional 132 weeks. This extension study involves a single treatment group receiving dazodalibep without placebo, focusing on ongoing treatment effects and participant safety. During the study, participants will be monitored for treatment-emergent adverse events for up to 152 weeks. Researchers will also measure the presence of anti-drug antibodies and plasma concentrations of dazodalibep for up to 132 weeks. Participants need to be available for all study visits and procedures, with safety assessments conducted regularly throughout the long-term extension period.

Researchers are conducting a master protocol study to evaluate the long-term safety and efficacy of the drug pirtobrutinib in patients who have completed previous clinical studies involving this medication. This study includes participants with chronic lymphocytic leukemia or non-Hodgkin lymphoma and aims to monitor their health over an extended period. The master protocol organizes individual study-specific appendices ISAs representing participants from earlier originator studies. Participants continue to receive pirtobrutinib as they did in their original clinical study, with the drug administered orally. The study allows these individuals to keep taking the treatment or to continue with follow-up visits under this master protocol framework. The study is designed to gather safety and survival data over many years. During the study, participants will be closely monitored for any serious treatment-related side effects, with assessments focused on adverse events occurring from the first dose until shortly after the last dose or when starting a new anticancer therapy. Researchers will also track overall survival for up to 93 months. This long-term follow-up ensures comprehensive safety and health evaluations throughout the participants involvement, which may last several years.