Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05607498

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

Led by EpimAb Biotherapeutics (Suzhou)Co., Ltd. · Updated on 2025-03-03

150

Participants Needed

10

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and able to provide informed consent and comply with study procedures
  • Male or female aged 18 years or older
  • For solid tumors: histologically or cytologically confirmed locally advanced unresectable or metastatic tumors limited to specified cancer types
  • For lymphoma: histologically or cytologically confirmed relapse/refractory lymphoma limited to CLL/SLL, mantle cell lymphoma, or diffuse large B cell lymphoma
  • Measurable or evaluable disease per RECIST V1.1 for solid tumors; at least one measurable lesion by imaging for lymphoma
  • Archival tumor samples available from within 2 years or fresh tumor biopsy at screening
  • ECOG performance status of 0 or 1
  • Adequate organ function
  • Recovery from adverse events related to prior anticancer therapy
Not Eligible

You will not qualify if you...

  • Prior treatment with any agent targeting ROR1
  • History of Grade 4 immune-related adverse events or immune-related adverse events requiring stopping prior therapies
  • Primary central nervous system malignancy or symptomatic CNS metastases requiring radiation treatment
  • Anticancer therapy or radiation less than 5 half-lives or 4 weeks prior to study treatment
  • Abuse of alcohol, cannabis-derived products, or other drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Peninsula and South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Actively Recruiting

2

One Clinical Research

Nedlands, Western Australia, Australia

Actively Recruiting

3

Hunan Cancer Hospital

Changsha, Hunan, China

Actively Recruiting

4

Affiliated Hospital of Hebei University

Baoding, China

Actively Recruiting

5

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Actively Recruiting

6

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Actively Recruiting

7

Zhujiang Hospital of Southern Medical University

Guangzhou, China

Actively Recruiting

8

The Affiliated Tumour Hospital of Harbin Medical University

Harbin, China

Actively Recruiting

9

Shandong Cancer Hospital

Shandong, China

Actively Recruiting

10

Tianjin Medical University Cancer Institue & Hospital

Tianjin, China

Actively Recruiting

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Research Team

S

Sai Lou

CONTACT

J

Junqiang He

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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