Phase 1 Study Evaluating Safety and Activity of Oral JBI-778 in EGFR-Mutated Lung Cancer, IDH-Mutated Recurrent Glioma, and Advanced Adenoid Cystic Carcinoma

What this Trial Is About

Researchers are studying the safety, drug levels, and clinical activity of an oral drug called JBI-778 in patients with certain advanced cancers. These include lung cancer with EGFR mutations, recurrent glioma with IDH mutations, and advanced adenoid cystic carcinoma. This phase 1, open-label study is the first time this drug is being tested in humans and aims to find the best dose with acceptable safety. Up to 42 patients will participate across multiple sites after regulatory approvals. Participants will receive JBI-778 capsules orally once daily in 21-day treatment cycles. The dose will start at 40 mg and may be increased in a stepwise manner based on safety results using a 33 design. Dose escalation focuses first on lung cancer and adenoid cystic carcinoma patients, with glioma patients added later once a safe dose is identified. Treatment may continue for up to two years if patients benefit and tolerate the drug. Additional patients may be enrolled at the recommended dose to collect more safety and early effect data. Participants will undergo screening to confirm eligibility before treatment. During the study, researchers will monitor safety through adverse event reporting and lab tests, assess drug levels in the blood, and evaluate disease response using imaging and clinical criteria. They will also collect tissue and blood samples to study drug effects. Follow-up includes a 30-day safety check after treatment ends and survival monitoring every three months. Total participation duration varies depending on treatment continuation and disease status.

First in Human Multicenter Open Name Dose-increase, Consolidation Method to Study Safety Drug-level in Blood & Drug Metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients With, Without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary Glands Tumor