Phase 1 Study of Oral AOH1996 for Treating Patients With Solid Tumors That Have Not Responded to Standard Treatments

What this Trial Is About

Researchers are evaluating the effects and optimal dosing of AOH1996 in patients with refractory solid tumors, meaning tumors that have not responded to standard treatments. This phase I trial aims to find the maximum tolerated dose, observe side effects, and determine the recommended dose for future studies. The study also explores how AOH1996 interacts with other therapies, such as tyrosine kinase inhibitors for non-small cell lung cancer, and measures preliminary effectiveness and biological effects on tumor cells. Participants receive the PCNA inhibitor AOH1996 orally twice daily for 28 days, which counts as one treatment cycle. These cycles repeat every 28 days as long as the disease does not progress and side effects remain acceptable. For those with non-small cell lung cancer, AOH1996 may be given alongside an EGFR tyrosine kinase inhibitor. After completing treatment, patients are followed for 30 days to monitor safety and side effects. During the study, participants will have regular evaluations including monitoring for adverse events and dose-limiting toxicities within the first 28 days of treatment. Researchers will also assess tumor response and disease control over up to two years. Blood tests and pregnancy tests, among others, will be done before and during treatment to ensure safety. The total participation length varies depending on treatment cycles and follow-up evaluations.

AOH1996 for the Treatment of Refractory Solid Tumors