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Researchers are evaluating the use of PET imaging with the radioligand 18FPI-2620 to detect tau protein deposits in people with Alzheimers disease and healthy controls. This open-label, multi-center, non-randomized Phase 3 study aims to compare PET imaging results during life with brain tissue analysis after death to better understand tau pathology in Alzheimers. The study is sponsored by Lantheus Biosciences Ltd. and focuses on diagnostic accuracy and safety of this imaging technique. Participants receive an intravenous injection of 18FPI-2620 at a dose of 185 MBq 20%. The study involves a PET scan procedure that participants must tolerate, including lying still in the scanner. There are no randomized groups or placebo controls as this is an open-label study. The research compares the PET imaging findings with post-mortem brain autopsy results to evaluate the ability of this imaging to detect tau deposits accurately. During the study, participants undergo PET imaging and are monitored for their ability to tolerate the scan. Brain donation consent is required for post-mortem histopathological comparison. Researchers assess the diagnostic performance of the PET scan in correctly identifying tau-related pathology and Alzheimers disease changes. The primary outcome focuses on the accuracy of visual assessment of PET images compared to autopsy findings, with follow-up continuing until study completion and an average of one year after death.

Researchers are evaluating new treatment options for people living with HIV-1 Human Immunodeficiency Virus Type 1 who have not been treated before. The current standard treatment, antiretroviral therapy ART, involves taking multiple medicines daily and may cause other health problems. This study aims to compare a new study ART combining two medicines, islatravir and ulonivirine, taken once a week, against the standard daily ART to see if it works as well and is safe and tolerable. Participants will receive one of several treatments for 96 weeks the study ART with islatravir and ulonivirine taken once weekly, the standard ART with bictegraviremtricitabinetenofovir alafenamide BICFTCTAF taken once daily, or combinations involving placebos matching these treatments. The study includes two phases Phase 2 which is open-label, and Phase 3 which is double-blind and randomized. During the study, participants will have regular assessments including measuring the amount of HIV-1 RNA in their blood and monitoring for adverse events and medication tolerance. Researchers will evaluate how well the treatments control the virus and affect immune cells over 24, 48, and 96 weeks. Safety monitoring will continue for about 102 weeks. The total study duration for participants is up to 96 weeks of treatment plus follow-up.

Researchers are evaluating the efficacy, safety, and tolerability of subcutaneous ianalumab in adults with diffuse cutaneous systemic sclerosis, a condition characterized by skin thickening and other systemic symptoms. This Phase 2 study compares ianalumab to a placebo to understand its impact on this disease, aiming to provide new treatment options for affected individuals. The study is sponsored by Novartis Pharmaceuticals and employs a randomized, double-blind design to ensure reliable results. Participants receive either ianalumab or placebo through subcutaneous injections during the initial 52-week treatment period. After this, all participants enter a second 52-week open-label phase where they receive ianalumab. Following treatment, there is a post-treatment follow-up lasting at least 20 weeks and up to 2 years to monitor long-term effects. The study includes a screening period lasting up to 6 weeks before treatment begins. Throughout the study, participants undergo regular assessments including measuring response based on the rCRISS25 scale at Week 52, lung function tests, skin scoring, and disability index evaluations. Blood samples are taken periodically to measure drug levels and antibodies. Safety is closely monitored through adverse event reporting up to Week 208. The total participation time can extend over several years including treatment and follow-up phases.

Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults with known or suspected metabolic dysfunction-associated steatohepatitis MASH with fibrosis at stages F2 or F3. This phase 3 clinical trial aims to understand how participants respond to this treatment compared to a placebo, focusing on managing this liver condition characterized by metabolic syndrome components and liver fibrosis. Participants will be randomly assigned to one of three groups two groups receiving different dose levels of Efimosfermin Alfa and one group receiving a placebo. The study involves administering the drug or placebo injections over a period of up to 52 weeks. Researchers will monitor participants throughout this time to assess the drugs effects and tolerability. During the study, participants will undergo regular assessments including laboratory tests for liver enzymes and fibrosis markers, imaging tests such as magnetic resonance elastography and MRI-derived fat fraction measurements, and evaluations of metabolic factors like blood sugar and cholesterol. Safety will be closely monitored by tracking adverse events and laboratory abnormalities. The total participation time is about one year, during which participants will have scheduled visits for treatment and evaluation.

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 investigating new treatments for neovascular age-related macular degeneration NVAMD, a condition that affects vision. This study aims to learn if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as well as the standard treatment called aflibercept. The trial is a pivotal Phase 23 study that compares these treatments in people newly diagnosed with NVAMD. Participants are randomly assigned to one of three groups one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. Those in the tiespectus groups get three initial injections every 4 weeks, then continue injections every 8 weeks until week 48, followed by treatments at intervals based on their individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks until week 92. During the study, participants are regularly assessed for changes in their best-corrected visual acuity using ETDRS letters from baseline to one year. Other evaluations include eye imaging to measure retinal thickness and monitoring for any adverse events up to approximately 96 weeks. The study lasts over one year with ongoing visits to track treatment response and safety.

Researchers are evaluating VVD-130037, a Kelch-like ECH Associated Protein 1 KEAP1 activator, in adults with advanced solid tumors in a first-in-human study. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of VVD-130037, both alone and combined with other cancer treatments. This is an open-label, phase 1 trial sponsored by Vividion Therapeutics, Inc., focusing on patients whose cancer has progressed despite prior standard therapies. Participants receive escalating doses of VVD-130037 orally once or twice daily in 21- or 28-day treatment cycles. In Part 1 dose escalation, VVD-130037 is tested alone and combined with intravenous docetaxel, paclitaxel, or pembrolizumab at established schedules. Part 2 dose expansion administers VVD-130037 at the recommended dose for expansion RDE, alone or in combination, to further evaluate safety and activity. Treatment cycles vary by combination, with docetaxel given every 3 weeks and paclitaxel given on days 1, 8, and 15 of each cycle. Participants undergo regular assessments including monitoring for dose-limiting toxicities during the first treatment cycle and tracking adverse events over up to 4 years. Laboratory tests, electrocardiograms, and imaging evaluations measure drug concentrations, heart rhythm, and tumor response. Researchers also evaluate overall response rates, duration of response, progression-free survival, and disease control rates. Safety follow-up and detailed pharmacokinetic studies are part of the long-term observation to understand the effects of VVD-130037 and its combinations.

Researchers are studying MEN2312, a lysine acetyltransferase 6 KAT6 inhibitor, in adults with advanced breast cancer that is not curable. This first-in-human, phase 1 study evaluates MEN2312 alone and in combination with elacestrant to understand its safety and determine the best dose. Participants have specific genetic alterations in their tumors and have received prior endocrine therapy and cyclin-dependent kinase 4 and 6 inhibitor treatment. Participants will be randomly assigned to receive either MEN2312 by itself or MEN2312 combined with elacestrant, both given as oral tablets. The study follows a sequential design and aims to identify dose-limiting toxicities and recommend the phase 2 dose over several months of treatment. This includes monitoring drug levels in the body and how the body processes the medications. During the study, participants will have regular assessments to monitor side effects, tumor response, and overall health. These include evaluating the number of dose-limiting toxicities within the first 28 days and tracking response rates, progression-free survival, and overall survival for up to nine months after treatment ends. Researchers will also measure drug concentration and excretion to better understand the treatment effects and safety over time.

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 BLU-924 SAR449336, a pan-KRAS inhibitor, in people with advanced pancreatic ductal adenocarcinoma, non-small cell lung cancer, or colorectal cancer that have specific KRAS mutations. This open-label Phase 12 trial aims to evaluate the safety, tolerability, how the drug moves through the body, and its antitumor effects in these participants. The study focuses on metastatic cancers with KRAS mutations and includes multiple stages to determine appropriate dosing and preliminary efficacy. Participants will receive BLU-924 as an oral tablet once daily during Dose Escalation, Dose Enrichment, and Dose Expansion phases. Dose Escalation and Enrichment are used to find the maximum tolerated dose and recommended dose for expansion, with dose levels adjusted based on safety and tolerability. Dose Expansion further studies safety and antitumor activity at the recommended dose in specific cancer types harboring KRAS mutations. There is no active combination treatment arm at this time. Throughout the study, participants undergo safety monitoring, evaluation of side effects, and pharmacokinetic assessments. Researchers will measure dose-limiting toxicities, adverse events, response rates, duration of response, disease control, progression-free survival, and overall survival over a follow-up period of up to five years. Blood tests, tumor imaging, and other clinical assessments will be conducted regularly to observe treatment impact and drug behavior in the body.