Badalona

Researchers are evaluating MDNA11, a long-acting beta-only recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 12 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11s effects alone and with pembrolizumab.

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.

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 evaluating MK-1045, an immunotherapy, in people with two types of non-Hodgkin lymphoma NHL follicular lymphoma FL, which grows slowly, and diffuse large B-cell lymphoma DLBCL, which grows more quickly. NHL is a cancer of the lymphatic system causing swollen lymph nodes. This study aims to assess the safety and tolerability of MK-1045 and to see if it can shrink or eliminate these lymphomas. Participants are randomly assigned to one of four groups receiving different doses or methods of MK-1045 administration. Dosages A, B, and D are given by intravenous IV infusion, while Dosage C is given by subcutaneous SC injection. Treatment lasts for up to approximately one year or until participants stop treatment for any reason. During the study, participants will be monitored for adverse events and treatment side effects, with measurements including tumor response using specific criteria. Blood levels of MK-1045 will also be tracked. The study involves regular visits for infusions and assessments. Participant safety and treatment effects will be followed for up to about 49 months in total.

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

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 evaluating the efficacy and safety of enicepatide, a dual GLP-1GIP receptor agonist, at multiple doses compared with placebo for weight management in adults with obesity or overweight and type 2 diabetes mellitus T2DM. This Phase III study aims to better understand how enicepatide affects body weight and other health measures in this population. Participants will be randomly assigned to receive either placebo or one of three dosing regimens of enicepatide, administered once weekly using an integrated drug-device combination product. The study lasts for 72 weeks, during which participants will self-administer the study drug or receive injections from a trained individual if needed. Throughout the study, participants will undergo various assessments including body weight, hemoglobin A1c, waist circumference, fasting glucose and insulin, cholesterol levels, blood pressure, and quality of life questionnaires. Safety will be monitored through adverse event reporting and specific rating scales. This comprehensive evaluation will help determine the effects of enicepatide on weight and diabetes management over the study period.

Researchers are studying new treatments for follicular lymphoma FL, a type of cancer affecting the lymphatic system. This trial evaluates the safety and effectiveness of a new immunotherapy called MK-1045 combined with rituximab, compared to the standard treatment of rituximab plus chemotherapy. The study aims to see if MK-1045 with rituximab can better control the cancer, help it go away, and extend the time patients live without their disease worsening. Participants in this trial receive MK-1045 through weekly intravenous infusions at increasing doses for up to about 12 months, alongside rituximab infusions every 4 weeks for up to 6 months. The comparison group receives physician-chosen chemotherapy treatments combined with rituximab over similar periods. Different chemotherapy options include bendamustine or combinations of cyclophosphamide, doxorubicin, vincristine, and prednisone or prednisolone. The study is divided into two parts Part 1 focuses on finding the right MK-1045 dose and safety, and Part 2 compares MK-1045 plus rituximab to standard chemotherapy plus rituximab. Throughout the study, participants undergo regular evaluations including scans to measure cancer size and tests to monitor safety and drug levels. Researchers track side effects, treatment tolerability, cancer response, and quality of life using questionnaires. The main outcomes include adverse events, response rates, and progression-free survival over several years. The trial lasts multiple years with monitoring up to about 5 years to understand long-term effects and benefits of the treatments.

Researchers are investigating new treatments for people aged 12 and older with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia B-ALL. This trial compares an experimental immunotherapy called MK-1045 to a standard immunotherapy called blinatumomab. The study aims to find out if MK-1045 leads to more patients having no cancer cells in their bone marrow and if it can help patients live longer than with blinatumomab. The study has two parts. Part 1 focuses on finding the best dose of MK-1045, with participants receiving either a lower or higher dose once a week for up to 13 cycles, each cycle lasting between 28 and 42 days. Participants receiving blinatumomab get it on days 1, 8, 15, and 22 of each 42-day cycle. At the end of Part 1, participants may choose to change treatments. Part 2 compares the effectiveness and safety of MK-1045 at the recommended dose versus blinatumomab. Participants will be closely monitored through bone marrow tests and other assessments to determine their response to treatment, including remission status and survival over up to seven years. Researchers will track side effects, treatment discontinuation, and long-term outcomes. The study includes regular visits for treatment and monitoring throughout the cycles and follow-up periods.

Researchers are investigating new treatments for locally advanced or metastatic urothelial cancer UC, a type of bladder cancer that has spread or cannot be removed by surgery or radiation. This trial evaluates whether sacituzumab tirumotecan sac-TMT, an experimental medicine, can help people with UC who have already been treated with specific therapies live longer compared to those who receive certain non-platinum chemotherapy options. The study is a Phase 3 randomized trial comparing sac-TMT with chemotherapy drugs selected by the investigator. Participants are assigned to one of two groups one receives sacituzumab tirumotecan at a dose of 4 mgkg every two weeks by intravenous infusion until the disease worsens or side effects become unacceptable. The other group receives one of three chemotherapy drugspaclitaxel, docetaxel, or vinflunineby intravenous infusion every three weeks, also until disease progression or unacceptable toxicity. Rescue medications may be given as needed to manage side effects according to approved guidelines. During the study, participants undergo assessments of overall survival up to about 40 months, along with other measures such as progression-free survival, response rates, duration of response, and quality of life evaluations using questionnaires. Safety is monitored by recording adverse events and treatment discontinuations. The total study participation may last several years, with regular evaluations to understand the effects and tolerability of the treatments.