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RECRUITING
NCT05607498
PHASE1

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

Sponsor: EpimAb Biotherapeutics (Suzhou)Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-03-01

Completion Date

2026-03-31

Last Updated

2025-03-03

Healthy Volunteers

No

Interventions

DRUG

EMB07

EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI

Locations (10)

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

One Clinical Research

Nedlands, Western Australia, Australia

Hunan Cancer Hospital

Changsha, Hunan, China

Affiliated Hospital of Hebei University

Baoding, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Zhujiang Hospital of Southern Medical University

Guangzhou, China

The Affiliated Tumour Hospital of Harbin Medical University

Harbin, China

Shandong Cancer Hospital

Shandong, China

Tianjin Medical University Cancer Institue & Hospital

Tianjin, China