Phase I Study Evaluating Safety and Tolerability of JLM019 Injection for Adults with Advanced Solid Tumors or RelapsedRefractory Lymphomas

What this Trial Is About

Researchers are evaluating the safety and tolerability of JLM019 Injection in adults with advanced malignancies, including advanced solid tumors and relapsed or refractory Hodgkin and Non-Hodgkin lymphomas. This is a phase 1, multicenter, single-arm, open-label study with dose escalation and dose expansion phases. The study aims to identify the recommended dose for combination therapy, assess dose-limiting toxicities, and monitor adverse events over time. Participants will receive JLM019 Injection through intravenous infusion at doses ranging from 0.001 to 10 mgkg. The infusion lasts at least 30 minutes and is scheduled once weekly in 28-day treatment cycles. Dose escalation follows an accelerated titration and a traditional 3 3 design, adjusting dose and interval based on pharmacokinetics, pharmacodynamics, and safety data. Treatment continues until disease progression, intolerable toxicity, need for new therapy, withdrawal, death, loss to follow-up, or other reasons. During the study, researchers will monitor safety through adverse event reports and laboratory tests, analyze drug levels and immune responses, and evaluate treatment efficacy using tumor assessments. Participants may undergo biopsies and imaging scans as scheduled. The study includes long-term follow-up for progression-free survival, duration of response, and overall survival up to 15 years. The total participation time varies based on individual treatment duration and follow-up assessments.

A Phase I Study of JLM019 Injection