Talas

Researchers are evaluating the safety, how the body processes the drug, and the effectiveness of calderasib alone or combined with other treatments in adults with advanced solid tumors that have a specific KRAS G12C mutation. This is a Phase 1, open-label, multicenter study focusing on participants with this genetic mutation in their tumors, aiming to understand how calderasib works alone and with other drugs. Participants receive calderasib as an oral dose, and some may also receive other medications such as pembrolizumab through intravenous infusion, or drugs like carboplatin, pemetrexed, cetuximab, oxaliplatin, leucovorin, and 5-fluorouracil according to standard guidelines. The treatments may be given alone or in combination depending on the study arm, with dosing schedules following label instructions or protocol specifications. During the study, participants will be closely monitored for any dose-limiting toxicities and adverse events, including reasons for stopping treatment. Researchers will assess these effects for up to about 21 days for dose-limiting toxicities and up to 56 months for adverse events and treatment discontinuation. The study involves regular evaluations to track safety, tolerability, and how well the treatment works over time.

Researchers are studying the effects of DMX-200 (repagermanium), a drug that blocks a receptor involved in inflammation, in people with focal segmental glomerulosclerosis (FSGS) who are also taking an angiotensin II receptor blocker (ARB). This Phase 3 trial aims to assess the safety and effectiveness of DMX-200 compared to placebo over 104 weeks in adults and adolescents aged 12 to 17 years. Following the initial study, an open-label extension will evaluate long-term safety and benefits for up to two more years. Participants will be randomly assigned to receive either DMX-200 at 120 mg twice daily or a placebo, while continuing their ARB treatment. The study includes a screening and qualification period lasting 6 to 14 weeks, a 104-week double-blind treatment phase, and a 4-week follow-up after treatment. Those completing this phase may enter the open-label extension for an additional minimum of 104 weeks, with another 4-week follow-up period, making the total study duration about 230 weeks. During the trial, participants will undergo regular assessments including urine protein and creatinine testing, kidney function monitoring by estimated glomerular filtration rate (eGFR), and safety evaluations. The main outcomes measured are changes in proteinuria, kidney function slope up to week 104, and long-term safety through week 216. Safety will be closely monitored throughout both the double-blind and extension periods to understand the drug's effects over time.

Researchers are evaluating the use of sacituzumab tirumotecan combined with pembrolizumab compared to pembrolizumab alone in treating adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death ligand 1 (PD-L1) expression of 50% or higher. This phase 3 study aims to determine if the combination therapy can improve overall survival. Participants must have confirmed NSCLC without certain gene mutations and meet other health criteria, including good performance status. Participants are randomly assigned to receive either sacituzumab tirumotecan plus pembrolizumab or pembrolizumab alone, both given by intravenous infusion. Supportive care measures, such as anti-nausea or blood growth factor treatments, may be provided as needed. Those who complete the first course of pembrolizumab may be eligible for up to nine additional cycles of pembrolizumab if disease progression is confirmed by central review. During the study, participants will be monitored for overall survival up to about 49 months. Researchers will assess responses to treatment using standard criteria and monitor side effects and safety. Various evaluations, including tumor tissue analysis and health status assessments, will be conducted to understand the impact of the treatments. The study also tracks supportive care use and any adverse events throughout participation.