L Hospitalet De Llobregat

Researchers are studying a new treatment combination for adults with advanced breast cancer that is estrogen receptor positive, HER2 negative, and GRPR positive. The trial aims to find the recommended dose of the drug [177Lu]Lu-NeoB when given with ribociclib and fulvestrant to participants who have experienced early relapse after endocrine therapy or whose disease has progressed after endocrine therapy combined with a CDK4/6 inhibitor. This Phase 1 study includes a dose escalation part and a backfill part to assess safety, tolerability, and preliminary effectiveness. Participants will receive [177Lu]Lu-NeoB once every 28-day cycle for six cycles, ribociclib daily on days 1 to 21 of each cycle, and fulvestrant on specific days beginning at cycle 1. Pre- or perimenopausal women and men will also receive goserelin. The trial includes imaging with the radioactive agent [68Ga]Ga-NeoB at screening, possibly at cycle 2 day 15, and again 4 to 8 weeks after the last dose of [177Lu]Lu-NeoB to help locate cancer lesions. During the study, participants visit the clinic regularly for treatment, safety checks, and tumor assessments. Safety follow-up continues for 8 weeks after treatment ends, with extended monitoring every 12 to 24 weeks for up to 5 years to track side effects, adverse events, and treatment interruptions. Researchers will closely observe any dose-limiting toxicities and evaluate overall safety and effectiveness throughout the study period.

Researchers are studying advanced renal cell carcinoma (RCC) that has returned after prior adjuvant therapy. The trial aims to find out if treatment with belzutifan and zanzalintinib helps patients live longer and delays disease progression compared to treatment with cabozantinib. This is a Phase 3 randomized study focusing on participants with recurrent advanced RCC who have previously received anti-PD-1/L1 therapy. Participants are randomly assigned to receive one of two oral drug regimens: either belzutifan combined with zanzalintinib, both taken once daily, or cabozantinib alone, also taken once daily. The study compares these treatments to assess their effects on disease control and overall survival. During the study, participants will be monitored for progression-free survival and overall survival for up to approximately 73 months. Researchers will evaluate how well the cancer responds to treatment and track any changes in health status over time. Safety and effectiveness of the treatments will be closely followed throughout the study period.

Researchers are evaluating new treatment options for women with relapsed high-grade serous ovarian cancer, a fast-growing cancer that starts in the cells covering the ovaries, lining of the belly, or fallopian tubes. This study focuses on people whose cancer has returned after prior platinum-based chemotherapy. The goal is to assess the safety, tolerability, and effectiveness of a new antibody drug conjugate called raludotatug deruxtecan (R-DXd), alone or combined with other anticancer treatments, in this patient group. The study has two parts: Part 1 is a dose escalation phase to find the recommended dose of R-DXd, and Part 2 is an expansion phase using that dose. R-DXd is given as an intravenous infusion on Day 1 of every 3-week cycle. Other treatments that may be given include carboplatin and paclitaxel (each up to 6 cycles), bevacizumab every 3 weeks, pembrolizumab up to 35 cycles, gemcitabine on Days 1 and 8 of each 3-week cycle, and pegylated liposomal doxorubicin every 4 weeks. Rescue medications to control side effects are also administered according to protocol. Participants will be monitored for adverse events, dose-limiting toxicities, and treatment discontinuations up to about 3 years. Researchers will measure cancer response using established criteria and assess safety through clinical exams, imaging, and laboratory tests. Eligibility includes having measurable disease and adequate health status. The study includes long-term follow-up to track treatment effects and safety outcomes over time.

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 evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

Researchers are evaluating ASTX030, a combination of azacitidine and cedazuridine, as a treatment for myeloid neoplasms including myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML). This multi-phase study includes Phase 1 through Phase 3 monotherapy arms and Phase 1 and Phase 2 combination therapy arms with venetoclax. The study aims to assess pharmacokinetics, safety, efficacy, and drug interactions over an approximate duration of 8 years. The study treatments involve oral administration of ASTX030 and azacitidine, with some arms including subcutaneous azacitidine for comparison. Phase 1 monotherapy includes dose escalation and expansion stages, while Phase 2 and Phase 3 monotherapy arms are randomized crossover studies comparing oral ASTX030 to subcutaneous azacitidine. The combination therapy arms explore ASTX030 combined with venetoclax in participants with treatment-nafve AML, either in an open-label randomized exploratory setting or a single-arm study. Participants undergo evaluations including pharmacokinetic measurements such as total cycle area under the curve (AUC) for drug exposure, assessment of treatment-emergent adverse events, and investigator-assessed complete response rates. Monitoring occurs at multiple timepoints up to 36 months in some study arms. Safety, efficacy, and drug interaction assessments are integral throughout the study, with follow-up periods extending up to 8 years.

Researchers are evaluating the efficacy, safety, and tolerability of two dosing regimens of itepekimab compared to placebo as an add-on treatment to intranasal corticosteroids in adult men and women with chronic rhinosinusitis with nasal polyps (CRSwNP). This multinational, randomized, double-blind, placebo-controlled Phase 3 study includes participants aged 18 years and older who have inadequately controlled CRSwNP. The study aims to better understand how these treatments impact nasal polyp symptoms and disease control over a one-year period. Participants will be randomly assigned to receive one of two dosing regimens of itepekimab or a placebo, all administered by subcutaneous injection. All participants will continue using mometasone furoate nasal spray as standard intranasal corticosteroid therapy. Treatment will last up to 52 weeks, followed by a 20-week safety follow-up period. The study includes a total of 9 site visits and 20 phone or home visits during the participant's involvement. Participants will be involved in regular assessments including endoscopic nasal polyp scoring and nasal congestion symptom evaluations at baseline and throughout the 24 weeks, among other time points. Researchers will monitor changes in nasal polyp scores and nasal congestion scores to measure the treatment effects. Safety and tolerability will be closely followed during the treatment and safety follow-up periods, with total participation lasting up to 76 weeks for most participants, or 56 weeks for those transitioning to an extension study.

Researchers are investigating new treatment options for adults with advanced solid tumors that have a KRASG12C mutation. This mutation causes cancer cells to grow, and while the drug sotorasib is approved to target these cancer cells, it usually works only for a limited time before the cancer grows again. The study is testing BAY3498264, a drug designed to block a protein called SOS1 that works with KRAS, hoping this will enhance the effects of sotorasib by providing a longer or stronger response. This is a first-in-human Phase 1 study focusing on the safety and best dosing of BAY3498264 when combined with sotorasib. Participants will first take BAY3498264 alone for seven days, then receive it together with sotorasib in repeated 21-day cycles. Sotorasib is given daily at a standard approved dose alongside BAY3498264. Treatment will continue as long as it benefits participants without causing severe side effects, or until the cancer progresses, or if the participant or doctor decides to stop. The study consists of three parts: dose escalation, backfill, and expansion to determine safe dosing and to monitor effects. Throughout the study, participants will have blood and urine samples collected and undergo imaging scans such as CT, PET, MRI, and X-rays. Their heart health will be checked using ECGs. Researchers will closely monitor safety by tracking any side effects, serious adverse events, drug levels in the blood, and any toxicities during the first treatment cycle. The study will last approximately three years to assess the maximum tolerated dose and overall safety of the drug combination.

Researchers are investigating treatments for adults with metastatic breast cancer that is estrogen receptor-positive, HER2-negative, and expresses gastrin releasing peptide receptor (GRPR). This study focuses on patients who have experienced disease progression after endocrine therapy combined with CDK4/6 inhibitors. The trial aims to find the best doses and schedules of [177Lu]Lu-NeoB combined with capecitabine and to evaluate the preliminary anti-tumor activity of this combination in this patient population. Participants will receive [177Lu]Lu-NeoB, a radioligand therapy, along with capecitabine, a chemotherapy drug. The study includes a phase I dose escalation to determine recommended doses, starting with 150mCi of [177Lu]Lu-NeoB every 6 weeks and capecitabine given twice daily for 14 days followed by 7 days off. Depending on safety, different dose levels and schedules will be explored. Phase II will randomize participants to treatment regimens based on phase I results. Imaging with [68Ga]Ga-NeoB PET/CT or PET/MRI will be performed during screening and after treatment in phase II to assess tumor GRPR expression. Participants will attend study visits approximately every 3 weeks for the first 9 months, then every 6 weeks, for treatment administration, safety monitoring, and tumor assessments. Tumor scans occur every 9 weeks until month 18, then every 12 weeks until month 36, and as needed afterwards. After stopping treatment, safety follow-up lasts 8 weeks, with longer-term follow-up for up to 5 years. Researchers will monitor safety, dose tolerability, tumor response, progression-free and overall survival, and other outcomes related to treatment effectiveness and side effects.