Pozuelo De Alarcon

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 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 evaluating the safety, efficacy, and optimal dosing of a combination of two investigational treatments, BNT323 trastuzumab pamirtecan and BNT327 pumitamig, in people with advanced breast cancer. This includes those with hormone receptor-positive or -negative, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study is a Phase III multi-site, open-label trial with a focus on advanced breast cancer treatment options. The study has two parts. Part 1 involves dose escalation of BNT323 combined with BNT327 to determine the recommended Phase 2 dose using six different dose levels. Part 2, which begins after Part 1 completion, includes dose optimization and exploratory cohorts. Cohort 1 in Part 2 uses randomization into four treatment arms, including combination therapy at different doses and monotherapies of either BNT323 or BNT327. Other cohorts receive the recommended dose without randomization. Participants will undergo assessments including tumor scans and cardiac function tests, with monitoring for side effects and tumor response up to 36 months. Researchers will track dose-limiting toxicities and treatment-emergent adverse events during early treatment cycles and monitor objective response rates and disease control over time. Safety and efficacy data will be collected through scheduled visits and tumor assessments during and after treatment to evaluate the study drugs effects and tolerability.

Researchers are evaluating the safety, effectiveness, optimal dose, and behavior of an investigational drug called BNT326, alone or combined with other immunotherapy agents, in adults with advanced solid tumors. This study includes patients with tumors that have either spread metastatic, returned after treatment, or progressed despite previous therapies, across various cancer types such as melanoma, lung cancer, breast cancer, gastric cancer, colorectal cancer, and cervical cancer. Participants are divided into two parts Part 1 tests BNT326 alone in different tumor-specific groups, some with dose randomization to find optimal dosing. Part 2 evaluates BNT326 alone or combined with another investigational drug called pumitamig in several cancer types, with some groups receiving randomized doses and others non-randomized treatments. Treatments are given via intravenous infusion, with some oral medications combined in Part 1. The study includes dose escalation and randomization phases, and treatment can continue for up to 24 months or until disease progression or other reasons. During the study, participants undergo screening, treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring phases. Researchers assess adverse events, treatment responses, disease progression, and drug behavior in the body using clinical evaluations and laboratory tests. Follow-up assessments occur up to approximately 38 months for Part 1 and 48 months for Part 2, with continued treatment possible for those benefiting from the therapy. The study aims to gather comprehensive data on safety, dosing, and effectiveness in this patient population.

Researchers are evaluating the safety and optimal dose of BNT329, an investigational drug, in people with advanced solid tumors that express the tumor marker CA19-9. The study also aims to assess how well BNT329 works by measuring participant responses and how long the tumor remains stable without growth or spread. Additionally, the study will examine how BNT329 moves through and affects the body. The trial includes up to four parts. Parts A and B focus on increasing doses to study safety and tolerability in participants with various advanced cancers expressing CA19-9 who have not responded well to previous treatments. Part C may be added if safety or effectiveness concerns arise, involving pre-dosing with a CA19-9 targeting antibody before BNT329. Part D tests two selected dose levels in participants with pancreatic ductal adenocarcinoma PDAC who have received prior treatment. Treatment is given as intravenous infusions every 2 or 3 weeks depending on the study part. Participants undergo screening, followed by treatment for up to two years, an end-of-treatment visit, two safety follow-ups, and a survival follow-up until death, withdrawal, or study end. Throughout the study, researchers monitor side effects, dose adjustments, tumor response, and survival. Blood samples will be collected to study drug levels and immune responses. Safety and effectiveness will be assessed up to 36 months from first dose.

Researchers are evaluating the impact of pelabresib on the pharmacokinetics of repaglinide, midazolam, and combined oral contraceptives containing drospirenone and ethinyl estradiol in adults with advanced malignancies who have no standard or curative treatment options. This Phase 1b study is designed to understand drug-drug interactions and assess continued treatment benefits in participants with these conditions. The study has two parts In Part 1, participants receive pelabresib 225 mg orally once daily for 14 days followed by a 7-day break. Arm A assesses interactions with single doses of repaglinide and midazolam, involving two hospital stays Arm B evaluates interactions with combined drospirenone and ethinyl estradiol, with hospital stays lasting from 2 to 10 nights. Part 2 allows participants who show clinical benefit to continue pelabresib treatment in additional cycles until study end or discontinuation criteria are met. Participants undergo screening before enrollment and receive assigned doses through an interactive response system. Assessments include plasma concentration measurements and pharmacokinetic profiles of the drugs at specific time points during 21-day cycles. Safety monitoring includes adverse event tracking up to 30 days after treatment ends, and participants with hematological malignancies have follow-up every 3 months for leukemic transformation until study completion or other defined endpoints. Total participation includes screening, treatment, follow-up, and monitoring phases.

Researchers are studying MEN2501, an oral drug, in adults with platinum-resistant ovarian cancer including high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This first-in-human, open-label trial aims to assess the safety, tolerability, how the drug moves through the body, its effects, and antitumor activity. The study is conducted in two parts dose escalation and dose expansionoptimization. In Part A, participants receive increasing doses of MEN2501 to evaluate dose-limiting toxicities during the first 28-day cycle. Part B focuses on determining the recommended phase 2 dose over approximately six months. The drug is given orally as tablets. The trial uses a sequential study model with randomized allocation and no masking. Participants will be monitored for treatment-emergent adverse events, tumor response rates, duration of response, clinical benefit, progression-free survival, overall survival, and drug concentration levels. These assessments occur over periods ranging from about six to twelve months. The total study duration extends to June 2028, with ongoing safety and efficacy follow-up through primary and secondary outcome measures.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the effectiveness, safety, and tolerability of camizestrant combined with ribociclib in patients with advanced ER-positive, HER2-negative breast cancer who have not received any prior systemic treatment for their advanced disease. This Phase IIIb global, multicenter, single-arm study aims to provide insight into this combination therapy as a first-line treatment option. Participants will receive daily oral tablets of camizestrant 75 mg and ribociclib 600 mg at standard doses continuously until they choose to stop treatment or it is discontinued for any reason. Approximately 150 participants will be enrolled and treated within this trial. During the study, participants will be monitored for treatment effectiveness using time to next treatment, time to discontinuation, and progression-free survival over a two-year period. Safety will be assessed by tracking adverse events, including any severe toxicities within the first six months. Participants will undergo regular assessments related to organ function and performance status throughout the treatment period, which may last until discontinuation.

Researchers are evaluating the safety and effectiveness of new drug combinations, including rilvegostomig with standard platinum-based chemotherapy, with or without ramucirumab, for treating advanced or metastatic non-small cell lung cancer NSCLC. This study is open-label and multicenter, involving participants with confirmed stage IV NSCLC. It includes a sub-study with safety run-in and expansion parts to find the best dose and assess treatment activity. Participants receive treatments infused intravenously, including rilvegostomig, ramucirumab, and chemotherapy drugs like cisplatin, carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel. Non-squamous NSCLC participants are randomly assigned to either rilvegostomig plus chemotherapy with ramucirumab or rilvegostomig plus chemotherapy alone, while squamous NSCLC participants receive rilvegostomig plus chemotherapy and ramucirumab. The study includes initial safety evaluation and dose expansion phases. During the study, participants undergo tumor tissue collection, disease measurements, and regular assessments of side effects, tumor response, and survival. Researchers monitor blood samples for drug levels and antibodies and track progression and overall survival over approximately 46 months. Safety, tolerability, and anti-tumor effects are closely followed throughout the treatment and observation periods.