Phase 1 Study of EMB-07, a Bi-specific Antibody, in Adults With Advanced Solid Tumors or RelapsedRefractory Lymphoma

What this Trial Is About

Researchers are evaluating EMB-07, a bispecific antibody, in patients with locally advanced or metastatic solid tumors and relapserefractory lymphoma. This phase I, open-label, dose escalation study aims to assess the safety, tolerability, and pharmacokinetics of EMB-07, while determining the maximum tolerated dose and recommended phase 2 dose. The study also examines immunogenicity and the anti-multiple myeloma activity of EMB-07. Patients with solid tumors or lymphoma receive weekly intravenous infusions of EMB-07. Dose escalation continues until reaching the maximum tolerated dose or recommended phase 2 dose, or until all planned doses are given. The study involves separate groups for solid tumors and lymphoma, each following the same dosing schedule. Participants will undergo safety monitoring for adverse events, serious adverse events, and dose-limiting toxicities throughout treatment and up to 30 days after the last dose. Researchers will measure pharmacokinetics, immunogenicity, tumor response, and progression-free survival over approximately six months. Tumor samples or biopsies are collected before treatment, and ongoing assessments include imaging, laboratory tests, and physical evaluations to track treatment effects and participant health.

First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma