Chuo City

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 treatments for breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), specifically in cases where the cancer is either locally advanced and cannot be removed by surgery or has spread to other parts of the body (metastatic). The study aims to determine if patritumab deruxtecan (also called HER3-DXd or MK-1022) helps patients live longer overall or without the cancer growing compared to chemotherapy or trastuzumab deruxtecan. This is a Phase 3 clinical trial focusing on this particular type of breast cancer. Participants receive one of several treatments: patritumab deruxtecan through intravenous infusion, chemotherapy options like paclitaxel or nab-paclitaxel via IV, oral capecitabine tablets, liposomal doxorubicin via IV, or trastuzumab deruxtecan via IV infusion. The study compares the effects of patritumab deruxtecan alone to the treatment chosen by the physician. Treatments are administered according to standard dosing schedules during the trial. During the study, participants are monitored for how long they live without the cancer progressing (up to about 45 months) and overall survival (up to about 85 months). Researchers assess disease status through imaging and other evaluations. Participants have regular check-ups to monitor health, treatment effects, and any side effects. The study tracks treatment response and safety over the extended follow-up period to understand the benefits and risks of the therapies.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are evaluating if ifinatamab deruxtecan (I-DXd), an antibody-drug conjugate that attaches to proteins on cancer cells to deliver treatment, can treat esophageal squamous cell carcinoma (ESCC). This Phase 2 open-label study aims to find out how many participants experience a reduction or disappearance of their cancer after receiving I-DXd. The trial is part of the KEYMAKER-U06 master screening protocol and focuses on patients with advanced or metastatic esophageal cancer who have already had prior treatments. Participants receive I-DXd through intravenous infusion, and rescue medications including 5-HT3 receptor antagonists, NK-1 receptor antagonists, and corticosteroids may be given according to approved guidelines to manage side effects. The study includes those with unresectable locally advanced or metastatic ESCC who have progressed after one or two previous systemic therapies. The study does not specify a maximum age limit but requires participants to be adults. During the study, researchers will monitor participants for up to approximately 15 months to measure the objective response rate, which means how many participants show cancer shrinkage or disappearance. Participants will undergo assessments to confirm diagnosis, measure disease progression, and monitor organ function. Safety will be closely observed, including monitoring for infections, cardiovascular issues, lung diseases, and other health conditions that might affect treatment. The goal is to better understand the treatment's effects and safety profile in this patient population.

This research aims to evaluate the safety and tolerability of CBA-1205, an anti-DLK1 monoclonal antibody, in patients with various advanced cancers including solid tumors, hepatocellular carcinoma (HCC), malignant melanoma, and pediatric cancers. It is a first-in-human, multicenter, open-label Phase I study conducted in five parts, focusing on patients who have no standard treatment options or who have not responded or are intolerant to standard therapies. The study also includes pharmacokinetic (PK) analysis to understand how the drug behaves in the body. The study is divided into five parts with different patient groups and dosing schedules. Parts 1 through 4 focus on adults with solid tumors, advanced or recurrent HCC, and malignant melanoma, testing escalating doses of CBA-1205 given intravenously ranging from 0.1 to 30 mg/kg. Part 5 focuses on pediatric cancer patients aged 2 to under 20 years, starting with a 10 mg/kg dose. Each part evaluates safety, tolerability, and determines recommended doses, with some parts also assessing efficacy. Participants will be closely monitored for dose-limiting toxicities during the first 28 days after the initial dose and for adverse events for up to 12 months. Assessments include physical exams, laboratory tests to check organ function and blood counts, and performance status evaluations. Safety will be continuously reviewed throughout the study. The total duration of participation varies by study part, with detailed follow-up to ensure participant well-being and collect data on treatment effects.

Researchers are evaluating BH-30643, a new oral drug, in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR and/or HER2 genes. This Phase 1/2 open-label, multicenter study aims to assess the safety, how the body processes the drug, and initial anti-tumor activity. Phase 1 focuses on finding the best dose and maximum tolerated dose, while Phase 2 will further study the drug's effectiveness and safety in specific patient groups based on mutation types and prior treatments. Participants will receive BH-30643 capsules orally at doses of either 10 mg or 40 mg, depending on their dose level assignment. The study includes a dose escalation period in Phase 1 to determine the recommended Phase 2 dose. After establishing this dose, Phase 2 will expand to evaluate the drug’s effect on tumor responses in different mutation subgroups and treatment histories. Throughout the study, participants will undergo various assessments including monitoring for dose-limiting toxicities within the first 21 days of treatment, evaluation of the recommended Phase 2 dose within 21 days after the last participant receives treatment in Phase 1, and measurement of tumor response rates approximately three years after the first dose in Phase 2. Safety, tolerability, pharmacokinetics, and pharmacodynamics will be closely tracked to understand the drug’s impact and side effects over time.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are evaluating whether adding intismeran autogene to pembrolizumab after surgery can help people with non-small cell lung cancer (NSCLC) remain cancer-free longer compared to pembrolizumab with a placebo. This study focuses on patients with NSCLC whose tumors did not completely respond to treatment before surgery and aims to prevent the cancer from returning. It is a Phase 3 randomized, double-blind study involving participants with resectable Stage II to IIIB (N2) NSCLC. Participants receive treatments including pembrolizumab given as an intravenous infusion and either intismeran autogene or placebo administered as an intramuscular injection. Before surgery, patients have received neoadjuvant pembrolizumab combined with platinum-based doublet chemotherapy, but only those who did not achieve a complete pathological response are eligible. The study compares the effects of pembrolizumab with or without intismeran autogene following surgery. During the study, participants are closely monitored for disease-free survival over a period of up to approximately 97 months. Researchers will assess whether the cancer returns and evaluate overall safety. Participants undergo regular evaluations including clinical assessments and laboratory tests to monitor their health and treatment response throughout the study period.

Researchers are evaluating new treatment options for people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or has come back after prior treatment. This type of cancer starts in the lining of the uterus and is considered advanced when it has spread locally or to other body parts and cannot be removed by surgery. The study aims to compare the effectiveness of sacituzumab tirumotecan (sac-TMT), an antibody drug conjugate, combined with pembrolizumab versus pembrolizumab alone, to see which approach helps people live longer without the cancer worsening. Participants first receive an induction phase of six cycles, each lasting three weeks, of pembrolizumab combined with carboplatin and either paclitaxel or docetaxel through intravenous infusions. Those whose cancer does not progress after this phase enter the maintenance treatment phase, where they are randomly assigned to receive either pembrolizumab plus sac-TMT or pembrolizumab alone. If the cancer does progress, participants may enter a subsequent treatment phase and be randomly assigned to pembrolizumab plus sac-TMT or sac-TMT alone. During the study, researchers monitor participants for progression-free survival and overall survival for up to approximately 44 and 54 months, respectively. Participants undergo regular imaging, assessments, and laboratory tests to evaluate cancer status and treatment effects. The study also tracks safety and tolerability throughout all phases, providing a comprehensive follow-up to understand treatment impact over time.