A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors

What this Trial Is About

Researchers are studying JMT108, a bispecific antibody drug, in adults with locally advanced or metastatic solid tumors who have not responded to or cannot tolerate standard treatments. The study aims to assess the safety, tolerability, and best dosing schedule of JMT108, as well as its effectiveness, how the body processes the drug, immune response to the drug, and preliminary anti-tumor activity. This Phase 1 trial includes dose escalation and cohort expansion phases to better understand the treatment's impact. The study involves two parts: Phase 1a dose escalation and Phase 1b cohort expansion. In the dose escalation phase, participants receive increasing doses of JMT108 by intravenous injection every two weeks, starting from 0.1 mg/kg up to 2 mg/kg, to find the maximum tolerated dose. Following evaluation, the study expands to include participants with various tumor types such as lung, colorectal, liver, gastric, melanoma, and other advanced solid tumors. The dose and schedule for this expansion phase are determined based on earlier results. Participants will provide consent, undergo screening to confirm eligibility, and attend regular study visits for treatment and monitoring. Researchers will assess tumor response using specific criteria and monitor for side effects, immune response, and how the drug is processed in the body. After treatment ends, participants will be followed every three months for up to two years to track disease progression and long-term outcomes. The entire participation duration varies depending on treatment response and study phase.

A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors