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Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

Researchers are evaluating VVD-130037, a Kelch-like ECH Associated Protein 1 KEAP1 activator, in adults with advanced solid tumors in a first-in-human study. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of VVD-130037, both alone and combined with other cancer treatments. This is an open-label, phase 1 trial sponsored by Vividion Therapeutics, Inc., focusing on patients whose cancer has progressed despite prior standard therapies. Participants receive escalating doses of VVD-130037 orally once or twice daily in 21- or 28-day treatment cycles. In Part 1 dose escalation, VVD-130037 is tested alone and combined with intravenous docetaxel, paclitaxel, or pembrolizumab at established schedules. Part 2 dose expansion administers VVD-130037 at the recommended dose for expansion RDE, alone or in combination, to further evaluate safety and activity. Treatment cycles vary by combination, with docetaxel given every 3 weeks and paclitaxel given on days 1, 8, and 15 of each cycle. Participants undergo regular assessments including monitoring for dose-limiting toxicities during the first treatment cycle and tracking adverse events over up to 4 years. Laboratory tests, electrocardiograms, and imaging evaluations measure drug concentrations, heart rhythm, and tumor response. Researchers also evaluate overall response rates, duration of response, progression-free survival, and disease control rates. Safety follow-up and detailed pharmacokinetic studies are part of the long-term observation to understand the effects of VVD-130037 and its combinations.

Researchers are evaluating the safety and effectiveness of combining immunotherapy with radiotherapy compared to immunotherapy alone for patients with advanced hepatocellular carcinoma HCC that involves major blood vessels. This Phase II study focuses on patients with unresectable or metastatic disease showing major vascular invasion, aiming to improve treatment outcomes for this serious liver cancer. The trial includes two treatment groups one receiving immunotherapy combined with proton beam radiation therapy, and the other receiving immunotherapy alone. The radiation dose and schedule are tailored by physicians based on normal tissue safety. Participants receive these treatments concurrently as part of the study interventions. Participants will be monitored for progression-free survival over about three years along with other outcomes like overall survival, time to progression, and response rates. The study involves regular assessments including imaging to measure tumor response and safety evaluations. This helps researchers track both treatment effects and any side effects throughout the study period.

Researchers are evaluating the effectiveness of IMC-001 in patients with metastatic or locally advanced TMB-High TMB-H solid tumors. This Phase 2 study aims to determine how well IMC-001 works in this specific group of cancer patients, focusing on those with tumors that have a high tumor mutational burden. The trial is sponsored by ImmuneOncia Therapeutics Inc. and seeks to understand the drugs impact on tumor response and patient survival. All participants receive IMC-001 through an intravenous infusion at a dose of 20 mgkg every two weeks, administered over 60 minutes. Treatment can continue for up to 2 years, with each treatment cycle lasting 14 days. Imaging scans to monitor tumor response are performed every 6 weeks during treatment and follow-up, including after the end of treatment. The study includes a safety follow-up visit 28 days after the last dose. Participants will be closely monitored with imaging every 6 weeks to assess tumor changes, progression-free survival, duration of response, and overall survival over an average of one year. Additional assessments include pharmacokinetic and immunogenicity evaluations. The study requires regular visits for treatment, scans, and follow-up, with maximum treatment duration of 2 years. Safety and response data are collected throughout the study period until disease progression or initiation of other treatments.

Researchers are evaluating IMVT-1402 in a global, randomized, double-blind, placebo-controlled Phase 2b study for adults with Graves disease GD who remain hyperthyroid despite antithyroid drug ATD treatment. The study aims to assess the efficacy, safety, and tolerability of IMVT-1402 in this population. Participants will receive one of two doses of IMVT-1402 or a placebo for 26 weeks. The study includes two experimental groups with different doses of IMVT-1402 and a placebo comparator group. Treatments are given over the same 26-week period to evaluate their effects. During the study, participants will be monitored to see if they become euthyroid and are able to stop ATD by Week 26. Researchers will measure thyroid hormone levels such as triiodothyronine T3 and free thyroxine FT4 at various time points, including Weeks 2, 4, and 26. Safety and tolerability will also be assessed throughout the trial, which is expected to complete in May 2027.

Researchers are evaluating the effects of a medicine called BI 764198 in adults and adolescents who have a kidney condition known as focal segmental glomerulosclerosis FSGS. This Phase 3 clinical trial aims to determine whether BI 764198 helps improve kidney function in people with primary FSGS or genetic FSGS linked to TRPC6 gene variants. The study is randomized and placebo-controlled, meaning participants are randomly assigned to receive either the medicine or a placebo, and neither the participants nor the researchers know which treatment each person receives. Participants take either BI 764198 tablets or placebo tablets once a day for up to two years, while continuing their usual medication for FSGS. The study involves two groups running in parallel. The main treatment period lasts 104 weeks about two years, during which the participants regularly visit the study site approximately every three months. Both groups are compared to see if BI 764198 affects kidney protein levels and function. During the study, participants provide urine samples regularly to assess their kidney health. Researchers measure changes in urine protein-creatinine ratio and kidney filtration rate from the start to the end of the treatment period. Questionnaires about health-related quality of life are also completed. Doctors monitor participants health and note any side effects throughout the two years. This thorough follow-up helps understand how BI 764198 impacts kidney disease and overall well-being.

Researchers are studying the effects of NGM120 in people with colorectal cancer who also have cancer cachexia, a condition involving significant weight loss. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess the safety, tolerability, and potential benefits of NGM120 in this population. Participants will receive either NGM120 or a placebo through subcutaneous injections. NGM120 is given in different dosing schedules low dose every 4 weeks, high dose every 4 weeks, or high dose every 8 weeks. Placebo is administered every 4 weeks. These treatments will be compared to evaluate differences. Throughout the study, participants body weight changes will be monitored for 12 weeks to assess treatment impact. Safety will be evaluated by tracking adverse events over 44 weeks. Participants will undergo regular assessments, including monitoring for treatment effects and side effects, with the total study duration extending up to 44 weeks.

Researchers are evaluating the effect of low-dose aspirin 100 mg daily on preventing gastric cancer in patients with early gastric cancer or high-grade adenoma who have undergone endoscopic resection and have a negative or eradicated Helicobacter pylori status. This randomized, placebo-controlled Phase 3 trial addresses limitations in previous studies by focusing specifically on gastric cancer prevention with appropriate sample size and follow-up. Aspirin is commonly used to reduce cardiovascular risks, and some evidence suggests it may also lower gastrointestinal cancer risk, but more targeted research is needed. Participants will be randomly assigned to receive either enteric-coated aspirin 100 mg daily or a placebo tablet for five years. This double-blind study compares the incidence of gastric cancer between the aspirin and placebo groups. The trial includes a treatment period of five years, during which participants take the assigned medication daily. The study also monitors secondary outcomes like mortality, cardiovascular events, occurrence of other cancers, gastric dysplasia, aspirin-related complications, and gastric tissue improvements. During the study, participants will undergo regular assessments including pathology reviews after endoscopic resection and monitoring for adverse events. Researchers will track the primary outcome of gastric cancer incidence throughout the treatment period. Secondary outcomes such as cardiovascular disease rates and overall survival will also be evaluated. The total participant involvement includes screening, a five-year medication period, and ongoing monitoring to assess treatment effects and safety.

Researchers are evaluating zongertinib, an oral drug targeting HER2 mutations, to see if it can improve outcomes compared with standard adjuvant treatments in adults who have had complete surgical removal of Stage II-IIIB non-small cell lung cancer NSCLC with activating HER2 tyrosine kinase domain mutations. This Phase 3, global, randomized, open-label study involves participants who have already received appropriate perioperative systemic therapy, including neoadjuvant or adjuvant platinum-based chemotherapy, with or without immunotherapy. Participants are randomly assigned in equal numbers to receive either zongertinib once daily by mouth for up to 3 years or standard treatment, which may include approved adjuvant immunotherapy or observation depending on local guidelines and patient status. The study compares disease-free survival between these groups and also monitors safety and patient-reported outcomes. Tumor samples are collected centrally to confirm HER2 status. During the study, participants undergo regular assessments to monitor disease status, safety, and quality of life. The primary outcome is disease-free survival, tracked for up to 8 years and 5 months. Secondary outcomes include overall survival and occurrence of significant adverse events over up to 3 years. Participant involvement may last several years, with follow-up continuing after treatment to assess long-term outcomes and safety.

Researchers are evaluating BOLD-100, an intravenous ruthenium-based small molecule drug, combined with FOLFOX chemotherapy for advanced gastrointestinal cancers, including colorectal, pancreatic, gastric cancers, and cholangiocarcinoma. This Phase 1b2a study aims to assess safety, tolerability, and anti-tumor activity, focusing on patients who have received limited prior treatment and have specific tumor characteristics. Participants receive BOLD-100 at different dose levels 500 mgm2 or 625 mgm2 combined with standard FOLFOX chemotherapy or FOLFOX alone. The study includes a dose escalation phase to ensure safety, followed by a cohort expansion phase. Some study arms are closed, while others, such as Arm VII for colorectal cancer patients, are actively enrolling with different treatment assignments. During the trial, participants will undergo regular monitoring for adverse events, dose-limiting toxicities, and clinical changes through physical exams, ECGs, lab tests, and performance assessments. Quality of life and neuropathy-related questionnaires will be completed. Researchers will evaluate progression-free survival, overall response, and overall survival, with follow-up continuing for about two weeks after the last treatment to assess these outcomes and collect pharmacokinetic and biomarker data.