NCT05607498

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

A First-in-human, Phase I, Open-Label Study of EMB-07, a Bi-specific Antibody Anti-CD3 and Receptor Tyrosine Kinase-like Orphan Receptor 1 (ROR1) in Patients With Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: EpimAb Biotherapeutics (Suzhou)Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-07 will also be assessed.

Detailed description

This is a phase I, multicenter, open label, dose escalation, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose for EMB-07 in patient with locally advanced/metastatic solid tumors or relapse/refractory Lymphoma . Pharmacokinetics, pharmacodynamics, immunogenicity and response will also be assessed.

Conditions

• Advanced/Metastatic Solid Tumors
• Relapse/Refractory Lymphoma

Interventions

Type	Name	Description
DRUG	EMB07	EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-10-31
• Completion: 2026-03-31
• First posted: 2022-11-07
• Last updated: 2025-03-03

Locations

10 sites across 2 countries: Australia, China