RecruitingPhase 1NCT05607498

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


Sponsor

EpimAb Biotherapeutics (Suzhou)Co., Ltd.

Enrollment

150 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is the first human study of a new drug called EMB-07 for people with hard-to-treat advanced solid tumors or relapsed/refractory lymphoma. Treatment Group A includes specific solid tumors, and Treatment Group B includes lymphoma. **You may be eligible if...** - You are 18 years or older - Treatment Group A: You have advanced unresectable or metastatic cancer of the breast (triple-negative), lung (adenocarcinoma), ovary, pancreas, colon/rectum, stomach, prostate, bladder, or uterus - Treatment Group B: You have a relapsed or refractory lymphoma confirmed by biopsy - You are willing and able to comply with all study procedures **You may NOT be eligible if...** - Your cancer type is not listed above - You have inadequate organ function, serious heart conditions, or active infections - You are pregnant or breastfeeding (check with your doctor for full exclusion criteria) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEMB07

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

View Full Details on ClinicalTrials.gov

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NCT05607498


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