Actively Recruiting
A First-in-human Study of EMB-07, a Bispecific Antibody Targeting CD3 and ROR1, in Patients With Advanced Solid Tumors or Relapse/Refractory Lymphoma
Led by EpimAb Biotherapeutics (Suzhou)Co., Ltd. · Updated on 2025-03-03
150
Participants Needed
10
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating EMB-07, a bispecific antibody, in patients with locally advanced or metastatic solid tumors and relapse/refractory lymphoma. This phase I, open-label, dose escalation study aims to assess the safety, tolerability, and pharmacokinetics of EMB-07, while determining the maximum tolerated dose and recommended phase 2 dose. The study also examines immunogenicity and the anti-multiple myeloma activity of EMB-07. Patients with solid tumors or lymphoma receive weekly intravenous infusions of EMB-07. Dose escalation continues until reaching the maximum tolerated dose or recommended phase 2 dose, or until all planned doses are given. The study involves separate groups for solid tumors and lymphoma, each following the same dosing schedule. Participants will undergo safety monitoring for adverse events, serious adverse events, and dose-limiting toxicities throughout treatment and up to 30 days after the last dose. Researchers will measure pharmacokinetics, immunogenicity, tumor response, and progression-free survival over approximately six months. Tumor samples or biopsies are collected before treatment, and ongoing assessments include imaging, laboratory tests, and physical evaluations to track treatment effects and participant health.
CONDITIONS
Brief 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 signed informed consent and comply with study procedures
- Male or female aged 18 years or older
- Patients with locally advanced unresectable or metastatic solid tumors including triple-negative breast cancer, lung adenocarcinoma, ovarian, pancreatic, colorectal, gastric, prostate, bladder, or uterus cancer
- Patients with relapse/refractory lymphoma including chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, or diffuse large B cell lymphoma
- For solid tumors: measurable or evaluable disease per RECIST V1.1
- For lymphoma: at least one measurable lesion by imaging or sufficient peripheral blood B lymphocytes for CLL patients
- Archival tumor samples available within 2 years or fresh 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 discontinuation of prior therapies
- Primary central nervous system malignancy or symptomatic CNS metastases (except those not requiring radiation or with completed radiation at least 4 weeks prior)
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until dose escalation completion or discontinuation
Participants receive weekly intravenous infusions of EMB-07. Dose escalation continues until the maximum tolerated dose or recommended phase 2 dose is reached, or all planned doses are administered.
Weekly visits for infusions
Duration - Up to 30 days
Participants are monitored for safety and adverse events for up to 30 days after the last dose.
1 to 2 visits for safety monitoring
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
J
Junqiang He
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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