Bellinzona

Researchers are investigating new treatment options for meningiomas that continue to grow despite local therapies like surgery or radiotherapy. This trial focuses on evaluating a precision medicine approach that combines PET-based imaging to select patients with tumors expressing somatostatin receptors and a targeted radioligand therapy called 177Lu-DOTATATE. This is the first randomized clinical trial studying this therapy in patients with meningiomas that have not responded to other treatments. Participants will be randomly assigned to one of two groups. One group receives 177Lu-DOTATATE through intravenous infusions every four weeks for a total of four cycles. The other group receives local standard care, which may include treatments like hydroxyurea, bevacizumab, sunitinib, octreotide, everolimus, or observation with supportive care, based on the investigators choice. This study is designed to compare the effects of 177Lu-DOTATATE against various standard treatments in this patient population. During the study, participants will undergo regular MRI scans to measure tumor size and progression. Researchers will also assess overall survival, neurological function, quality of life, and treatment side effects over a period extending up to two years after enrollment. Monitoring includes imaging, laboratory tests, and health questionnaires to evaluate how the disease and treatments affect participants over time.

Researchers are investigating whether sacituzumab tirumotecan alone or combined with other treatments can treat certain advanced or unresectable gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to understand the safety and tolerability of sacituzumab tirumotecan and how well the cancer responds to these treatments. Participants will receive sacituzumab tirumotecan in different dose levels either combined with chemotherapy every two weeks in a 4-week cycle, alone every two weeks in a 4-week cycle, or combined with cisplatin and pembrolizumab in a 3-week cycle. Treatment continues until the cancer worsens or participants cannot tolerate it. Cisplatin is given up to approximately six months, and pembrolizumab is administered for up to about two years in the combination group. During the study, participants will have regular assessments to monitor safety, side effects, and how the cancer responds via imaging and clinical evaluation. Researchers will track dose-limiting toxicities, adverse events, treatment discontinuations due to side effects, and objective response rates. Additional measures include duration of response, progression-free survival, and overall survival, with monitoring lasting up to approximately 63 months.

Researchers are evaluating new treatments for advanced ovarian cancer in women who have completed initial surgery and chemotherapy. The study focuses on non-HRD positive ovarian cancer, comparing a targeted therapy called sacituzumab tirumotecan sac-TMT given alone or with bevacizumab, against standard care options such as bevacizumab maintenance or observation. The goal is to see if sac-TMT with or without bevacizumab can help patients live longer without their cancer worsening. Participants in the experimental group will receive sac-TMT through intravenous infusion on days 1, 15, and 29 of every 6-week cycle until the cancer progresses, side effects become prohibitive, or other reasons for stopping arise. They may optionally receive bevacizumab on days 1 and 22 of each cycle. The comparator group will either receive bevacizumab alone every 3 weeks for up to 22 courses or be monitored without active treatment. Supportive medications like steroid mouthwash and other rescue drugs are recommended before sac-TMT infusions. Throughout the study, participants will be regularly monitored for how long they live without their disease progressing, overall survival, side effects, and quality of life using specialized questionnaires. These assessments will continue for up to approximately 78 months. The study is randomized, with single masking, and led by Merck Sharp & Dohme LLC. Participants can expect regular visits for treatment and monitoring during this period.

Researchers are evaluating ODM-212, a drug being studied in a first-in-human, multi-site, open-label Phase 12 clinical trial involving adults with selected advanced solid tumors that cannot be treated with curative intent. The study aims to assess the safety and side effects of ODM-212 in patients who have cancers such as mesothelioma, lung carcinoma, colorectal cancer, and others with specific genetic alterations. This research is sponsored by Orion Corporation, Orion Pharma. Participants receive ODM-212 tablets at doses of 5mg andor 40mg. The study has two parts an initial dose escalation phase to find a safe dose, followed by a dose expansion phase that includes patients with solid tumors harboring specific genetic pathway alterations. Treatments are given orally, and dosing details are adjusted based on patient response and safety observations. During the study, participants will be monitored from the first dose until one year after the last study visit to track treatment-emergent adverse events and their severity. Regular assessments include physical exams, laboratory tests, and performance status evaluations. Participants must comply with the protocol and provide informed consent. The total study duration varies based on treatment and follow-up schedules.

Researchers are evaluating petosemtamab compared with investigators choice monotherapy in patients with incurable metastatic or recurrent head and neck squamous cell carcinoma HNSCC who have previously been treated. This phase 3 open-label, randomized controlled study focuses on patients whose disease has progressed after anti-PD-1 and platinum-containing therapies. It aims to assess effectiveness and safety for second- and third-line treatments in this population. Participants will be randomly assigned to receive either petosemtamab or one of several investigators choice monotherapies, including cetuximab, methotrexate, or docetaxel. The treatments are given as part of a controlled multicenter trial. The study includes follow-up periods to evaluate responses and safety outcomes over time. During the study, participants will undergo regular assessments including radiologic evaluations to measure tumor response according to RECIST criteria, physical performance status checks, and laboratory tests to monitor organ function and adverse events. Researchers will track overall survival for up to approximately three years and evaluate other outcomes such as progression-free survival, response rates, quality of life measures, and treatment safety. The total duration of participation is aligned with treatment and outcome measurement timelines as specified.

Researchers are studying the impact and burden of three skin conditions moderate or severe alopecia areata, non-segmental vitiligo, and moderate to severe hidradenitis suppurativa. The study includes adolescents and adults and aims to understand how these conditions affect quality of life and daily functioning in a large global population. This is an observational study where participants with each condition will have a single visit for data collection following routine clinical practice. No experimental treatments are given instead, the study gathers information during this one visit to assess disease characteristics and impact. During the visit, participants will complete questionnaires and clinical assessments specific to their condition. These include tools measuring symptom impact, hair loss severity, skin depigmentation, and quality of life related to each disease. This helps researchers better understand the real-world burden of these conditions. Participation involves only this one visit, with no long-term follow-up or additional procedures.

Researchers are evaluating the safety, how the body processes the drug, and the effects of calderasib alone and in combination with other therapies in adults with advanced solid tumors that have a specific genetic mutation called KRAS G12C. This study focuses on participants with measurable disease and adequate organ function who have this mutation confirmed by tissue or blood testing. It is a Phase 1 trial aiming to understand treatment tolerability and effectiveness in this patient group. Participants receive different study treatments depending on their assigned group. Some receive daily oral escalating doses of calderasib up to 800 mg until the disease progresses or treatment stops. Others receive calderasib combined with pembrolizumab infusions every 21 days for up to about 24 months, sometimes along with other chemotherapy drugs like carboplatin, pemetrexed, cetuximab, oxaliplatin, leucovorin, and 5-fluorouracil, given according to standard dosing schedules. Dosing may be adjusted based on safety. The study includes several treatment arms with different combinations. During the study, participants undergo regular safety monitoring, including tracking dose-limiting toxicities and adverse events over approximately 56 months. Researchers measure treatment effects, such as tumor response and duration, and study how calderasib behaves in the body through blood tests at designated times during treatment cycles. Participants will be followed through multiple cycles lasting 3 or 4 weeks depending on the arm, with assessments continuing for up to about 56 months to capture long-term effects and safety.

Researchers are evaluating the safety and effectiveness of INCB123667 in women with platinum-resistant ovarian cancer that shows cyclin E1 overexpression. This phase 2, single-arm study focuses on participants whose cancer has not responded well to previous platinum-based treatments, aiming to explore new therapeutic options for this condition. Participants will receive INCB123667 orally twice daily at doses determined by their tumors cyclin E1 expression levels. The study includes multiple cohorts receiving this treatment according to the protocol. The treatment period and dosing follow specific guidelines based on tumor characteristics to assess the drugs impact. Throughout the study, participants will be monitored for treatment response and safety for up to two years. Assessments include evaluating tumor response by independent review and investigator evaluation, measuring progression-free and overall survival, and tracking any adverse events related to the treatment. This close monitoring helps researchers understand the treatments effects and safety profile over time.

Researchers are evaluating neladalkib NVL-655, an oral drug, in a Phase 12 study for patients with advanced ALK-positive non-small cell lung cancer NSCLC and other solid tumors. The study aims to assess the safety and tolerability of neladalkib, determine the recommended phase 2 dose, and evaluate its antitumor activity. A sub-study also investigates potential interactions between neladalkib and other drugs such as midazolam, repaglinide, and itraconazole in patients with advanced ALK-positive NSCLC. The study includes Phase 1 dose escalation to find the safe dose and Phase 2 dose expansion with six patient groups based on prior treatments and tumor types. Patients receive daily oral neladalkib. The sub-study enrolls patients into two cohorts to study drug interactions involving midazolam, repaglinide, and itraconazole. Eligible patients may have received various prior therapies including ALK tyrosine kinase inhibitors TKIs, chemotherapy, or immunotherapy depending on their cohort. Participants will undergo regular assessments such as scans and lab tests to monitor disease response and safety. Researchers will measure outcomes including dose limiting toxicities, objective response rate, duration of response, progression-free survival, overall survival, and quality of life over approximately three years. The study also monitors drug levels and adverse events closely, including in the drug interaction sub-study, with follow-up extending to months after the last dose.

Researchers are studying NX-5948, an oral drug, in adults with relapsed or refractory B-cell malignancies, including various lymphomas and leukemias such as Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Diffuse Large B-cell Lymphoma, and others. This Phase 1a1b open-label trial aims to assess the safety, tolerability, and anti-cancer activity of NX-5948 in patients who have received prior treatments and have limited options. The study includes multiple cohorts focusing on different types of B-cell cancers and specific patient characteristics. The study has two main parts Phase 1a dose escalation to determine the maximum tolerated dose and recommended dose for further study, followed by Phase 1b safety expansion and cohort expansion to evaluate the drugs anti-tumor activity at selected doses across various patient groups. Participants receive oral NX-5948 at different dose levels, with some groups randomized to compare doses. The treatment targets a range of B-cell malignancies, including those affecting the central nervous system. Participants are closely monitored throughout the study for dose-limiting toxicities, adverse events, and anti-tumor responses using established criteria. Assessments include measuring overall response rates, pharmacokinetics, pharmacodynamics, and survival outcomes over periods lasting up to several years. The study involves regular visits for safety and efficacy evaluations, and participants organ and bone marrow functions are monitored to ensure suitability for treatment.