San Antonio

Researchers are evaluating the effectiveness, how the body processes the drug, and safety of remibrutinib compared to a placebo in adolescents aged 12 to less than 18 years with chronic spontaneous urticaria not well controlled by H1-antihistamines. The study also aims to collect long-term data on the drug's safety, tolerability, and effectiveness after 24 weeks of treatment and monitor safety up to three years after the last dose. The trial includes three periods: a 24-week double-blind, randomized core period where two-thirds of participants receive remibrutinib orally twice daily and one-third receive placebo, followed by an optional open-label extension where participants who completed the core period may receive remibrutinib for up to six cycles of 24 weeks or enter a treatment-free observational period for up to one year, with options to switch based on symptoms. A further optional long-term treatment-free follow-up lasts up to three years with limited visits. Participants will have about 10 site visits during the core period and between 3 and 15 visits during the extension depending on symptoms, plus annual follow-up visits and phone calls during the long-term follow-up. Researchers will assess changes in urticaria activity and severity scores at baseline and week 12, monitor drug levels in the blood, track adverse events, and evaluate quality of life. Safety and symptom control are closely monitored throughout all study periods.

Researchers are evaluating the safety and effectiveness of tenapanor in adults with Chronic Idiopathic Constipation (CIC). This study is a 26-week, multi-center, randomized, double-blind, placebo-controlled trial followed by a 4-week treatment-free safety follow-up period. It aims to compare three different doses of tenapanor with a placebo taken twice daily to assess their impact on constipation symptoms. The study includes a 2-week screening period to confirm eligibility, followed by a 26-week randomized treatment period where patients receive either 5 mg, 25 mg, or 50 mg of tenapanor twice daily, or a matching placebo. Patients record their constipation symptoms daily in an electronic diary. After the treatment period, there is a 4-week safety follow-up without treatment to monitor any adverse effects. Participants will have regular visits every 2 to 6 weeks for safety checks including medical assessments, vital signs, ECG, and lab tests. Their symptom diaries will be reviewed throughout the study. The main outcome measured is the durable complete spontaneous bowel movements response at 12 weeks. Secondary outcomes include changes in bowel movement frequency, stool consistency, and straining. The total study duration is approximately 32 weeks including all phases.

Researchers are evaluating new treatment options for people with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific gene mutation called KRAS G12C. This study aims to learn about the safety and tolerance of adding calderasib and cetuximab, two targeted therapies, to a chemotherapy regimen called mFOLFOX6. The study also compares how long participants live without their cancer growing or spreading when receiving the combination treatment versus standard chemotherapy with or without bevacizumab. The study has two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil given every two weeks. The other group will receive mFOLFOX6 chemotherapy every two weeks, with or without bevacizumab or a bevacizumab biosimilar, based on the investigator's choice. Treatment continues until certain criteria are met for stopping. Participants will be closely monitored through up to approximately 44 months or longer for side effects, treatment discontinuation, and how long their cancer remains stable without worsening. Researchers will also assess survival, quality of life using questionnaires, and response to treatment over several years. Safety and efficacy data will be collected throughout the study duration, which includes follow-up assessments up to 5 years.

Researchers are studying a medicine called enlicitide to lower low-density lipoprotein cholesterol (LDL-C) in people with high cholesterol. This trial aims to learn if enlicitide given with rosuvastatin, a standard cholesterol-lowering treatment, works better than a placebo. The study is a phase 3, randomized, double-blind, placebo-controlled trial evaluating the combination's effect on LDL-C levels in adults with hyperlipidemia. Participants will be assigned to one of four groups: enlicitide with a placebo matching rosuvastatin, enlicitide with rosuvastatin, rosuvastatin with a placebo matching enlicitide, or placebos for both drugs. All treatments are taken orally once daily for up to 12 weeks. This setup helps researchers compare the effects of enlicitide alone, rosuvastatin alone, their combination, and placebo. During the study, participants will have their LDL-C levels measured at baseline and at weeks 8 and 12. Researchers will also monitor apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and adverse events. The main outcome is the percent change in LDL-C at week 8. Safety and tolerability are assessed throughout the treatment and up to about 20 weeks. The total participation duration is up to 12 weeks of treatment with follow-up monitoring.

Researchers are evaluating KTX-2001, alone and in combination with darolutamide, in men with metastatic castration-resistant prostate cancer (mCRPC). This first-in-human Phase 1 clinical trial aims to study the safety, how the drug behaves in the body, and its initial effectiveness in treating mCRPC. The goal is to find safe dose levels and understand how KTX-2001 works with darolutamide, an oral androgen receptor pathway inhibitor. Participants will receive escalating doses of KTX-2001 either by itself or combined with darolutamide taken orally at a dose of 600 mg twice a day (total 1200 mg daily). The study has two parts: Part A tests KTX-2001 alone, and Part B tests the combination with darolutamide. Doses will increase to assess tolerance and safety, with treatment given continuously during the study periods. During the trial, participants will have regular assessments including biopsies of metastatic sites when possible, blood tests to monitor safety and drug levels, and scans to confirm metastatic disease. Researchers will track dose-limiting toxicities over 21 days to determine maximum tolerated doses and monitor adverse events for up to three years. The study team will also evaluate pharmacokinetics and recommend doses for future studies, with total participation lasting up to about three years.

Researchers are evaluating new treatments for hormone receptor-positive, HER2-negative breast cancer that cannot be removed by surgery or has spread to other parts of the body. This study focuses on patients whose cancer has either locally advanced or metastatic disease and have previously received specific hormone and targeted therapies. The goal is to see if treatment with patritumab deruxtecan can help patients live longer or delay cancer progression compared to other chemotherapy options or trastuzumab deruxtecan. Participants are randomly assigned to receive either patritumab deruxtecan through intravenous infusion every three weeks for about 13 months or a treatment chosen by their doctor, which may include various chemotherapy drugs or trastuzumab deruxtecan. The study treatment options in the doctor’s choice group are given on different schedules, such as weekly or every three to four weeks, depending on the drug selected. Throughout the study, participants will be closely monitored with regular assessments to measure progression-free survival and overall survival for up to approximately 45 and 85 months respectively. Researchers will also evaluate tumor response, quality of life using specific questionnaires, and track any side effects. The study includes long-term follow-up to understand the impact of treatment over time and ensure participant safety.

Researchers are investigating new treatments for high-risk, early-stage breast cancers that are either triple-negative or hormone receptor-low positive and HER2-negative. These types of breast cancer have limited amounts of certain proteins that affect growth, making them challenging to treat. This Phase 3 trial aims to compare the effects of adding sacituzumab tirumotecan, a targeted therapy, to pembrolizumab and chemotherapy against pembrolizumab with chemotherapy alone in controlling cancer growth and spread. Participants are randomly assigned to one of two treatment groups. One group receives sacituzumab tirumotecan intravenously every two weeks along with pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab combined with carboplatin and paclitaxel for another 12 weeks. After this, surgery and optional radiation therapy occur, followed by pembrolizumab infusions for up to about 28 weeks. Additional treatments such as olaparib, capecitabine, or doxorubicin with cyclophosphamide may be given if cancer remains. The other group receives chemotherapy drugs carboplatin, paclitaxel, cyclophosphamide, and doxorubicin or epirubicin alongside pembrolizumab during similar time frames, followed by surgery, radiation, and pembrolizumab maintenance with possible additional treatments. Throughout the study, participants undergo assessments including surgery to remove tumors, imaging, and laboratory tests. Researchers measure cancer cell presence after surgery and monitor how long participants live without cancer progression or recurrence, as well as overall survival. Quality of life and side effects are tracked using questionnaires over several years. Safety is monitored by recording adverse events and treatment discontinuations. The study may last up to around 115 months for long-term follow-up.

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. This phase 2 study compares the effects of zilovertamab vedotin combined with R-CHP chemotherapy versus polatuzumab vedotin combined with R-CHP in people newly diagnosed with this type of lymphoma. The goal is to see if the cancer responds better to one treatment over the other. Participants will be randomly assigned to receive either zilovertamab vedotin or polatuzumab vedotin, both given by intravenous infusion on the first day of each 3-week cycle for up to six cycles (about 4 months). Alongside these drugs, participants will receive cyclophosphamide, doxorubicin, and rituximab or a rituximab biosimilar by IV infusion, plus prednisone or prednisolone orally for five days each cycle. Those with high-risk DLBCL may receive two additional cycles of rituximab or its biosimilar. During the study, participants will have scans and tests to measure cancer response using established criteria over up to 31 months. Researchers will also monitor survival rates, quality of life, and side effects for up to several years. Safety assessments and treatment adherence will be tracked throughout the study and follow-up periods, ensuring thorough evaluation of each treatment's impact.

Researchers are evaluating the safety, effectiveness, and optimal dosing of two investigational treatments, BNT323 (trastuzumab pamirtecan) and BNT327 (pumitamig), in people with advanced breast cancer. This includes various types of breast cancer such as hormone receptor-positive or negative, HER2-positive, HER2-low, HER2-ultralow, HER2-null, and triple-negative breast cancer. The study is a Phase I/II trial conducted at multiple sites and aims to understand how these treatments work together and their safety profiles. The study has two parts. Part 1 involves dose escalation where participants with certain types of advanced breast cancer receive increasing doses of the combination of BNT323 and BNT327 to find the recommended dose for further study. Part 2 expands to test this optimal dose and includes four groups, with one group randomly assigned to one of four treatment arms: combination therapy at the recommended dose, combination therapy, BNT323 alone, or BNT327 alone. Some groups receive fixed doses while others explore different doses and combinations. Participants will receive treatments via intravenous infusion and undergo regular tumor scans and safety assessments for up to 36 months. Researchers will monitor for side effects, treatment-related complications, and tumor response. They will also track treatment interruptions or dose changes due to side effects. The study includes careful heart function checks before starting treatment and continuous safety monitoring during and after therapy to evaluate overall treatment impact.

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis at stages F2 or F3. This phase 3, randomized, double-blind, placebo-controlled study aims to better understand how this drug affects participants with this liver condition related to metabolic syndrome components. Participants will be randomly assigned to one of three groups: one receiving Efimosfermin Alfa at dose level 1, another receiving Efimosfermin Alfa at dose level 2, and a third group receiving a placebo. The study will monitor the effects of these treatments over a period of 52 weeks, assessing safety and tolerability as well as changes in liver fibrosis markers and other related health measures. During the trial, participants will undergo regular assessments including laboratory tests, imaging scans such as MRI and elastography to measure liver stiffness and fat content, and blood tests to monitor liver enzymes and metabolic markers. Researchers will track treatment-emergent adverse events and laboratory abnormalities. The study involves continuous monitoring up to week 52 to evaluate changes from baseline and to ensure participant safety throughout the trial.