Michigan Center

Researchers are studying the safety and effectiveness of a drug called DWN12088 in people diagnosed with Idiopathic Pulmonary Fibrosis (IPF), a lung condition. This is a Phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. The goal is to see how DWN12088 compares to a placebo in patients who meet specific lung function criteria and have stable disease under current standard treatments or no treatment. Participants will receive either DWN12088 tablets or placebo tablets twice daily. The study treatment period lasts 24 weeks. Throughout this time, patients continue their local standard care for IPF if applicable, such as pirfenidone or nintedanib, provided the dose has been stable for at least 3 months before screening. The study carefully monitors the participants for any side effects and how their lung function changes over the 24 weeks. During the study, participants will undergo various assessments including medical history, physical exams, vital signs, ECG, and laboratory tests to confirm their stability and eligibility. Researchers will track lung function decline and record any treatment-related adverse events from the start of treatment through 24 weeks. This helps evaluate both the safety and benefits of DWN12088 in managing IPF over this period.

Researchers are evaluating the safety and appropriate dosing of an oral drug called CB-03-10 in people with advanced solid tumors that have not responded to standard treatments. This early phase 1 study aims to find the maximum tolerated dose and recommended dose for further studies while assessing the drug's effects in specific tumor types. Participants will undergo initial evaluations to determine the extent of their disease before starting treatment. The study has two parts: Part 1 uses a dose escalation method where participants receive increasing doses of CB-03-10 based on a standard oncology design to identify the safest maximum dose. Plasma samples will be collected at specific times to study the drug's behavior in the body. In Part 2, participants receive CB-03-10 at the dose identified in Part 1, focusing on particular tumor subtypes determined by a Safety Review Committee. Participants will be monitored weekly at first—two cycles in Part 1 and one cycle in Part 2—then every two weeks afterward. Disease reassessment happens at Week 8 and every 8 weeks after that. If participants show signs of improvement, they will be checked again after at least 4 weeks to confirm the response. The main outcomes measured are the highest dose that can be tolerated and any dose-limiting side effects within about one month of treatment.