Actively Recruiting
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
Eligibility Criteria
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
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
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
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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