Trial Title:
First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma
NCT ID:
NCT05607498
Condition:
Advanced/Metastatic Solid Tumors
Relapse/Refractory Lymphoma
Conditions: Official terms:
Lymphoma
Recurrence
Conditions: Keywords:
Phase I
Bispecific antibody
CD3
ROR1
EMB07
Dose escalation
Advanced/Metastatic Solid Tumors
Relapse/Refractory Lymphoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EMB07
Description:
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI
Arm group label:
EMB-07-Patients with solid tumor
Arm group label:
EMB07-Patients with lymphoma
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.
Detailed description:
This is a phase I, multicenter, open label, dose escalation, first in human study,
designed to assess safety and tolerability, and to identify the maximum tolerated dose
(MTD) and/or recommended Phase 2 dose for EMB-07 in patient with locally
advanced/metastatic solid tumors or relapse/refractory Lymphoma . Pharmacokinetics,
pharmacodynamics, immunogenicity and response will also be assessed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Willing and able to provide signed and dated informed consent prior to any
study-related procedures and willing and able to comply with all study procedures.
2. Male or female, and aged ≥ 18 years
3. Treatment group A: Patients with histologically or cytologically locally advanced
unresectable or metastatic solid tumors limiting to triple-negative breast cancer,
lung adenocarcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, gastric
cancer, prostate cancer, bladder cancer, and uterus cancer. Treatment group B:
Patients with histologically or cytologically relapse/refractory lymphoma limiting
to chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell
lymphoma (MCL) and diffuse large B cell lymphoma (DLBCL).
4. Treatment group A: Standard therapies do not exist, or are no longer effective, or
are not tolerable or accessible to the patient measurable or evaluable disease per
RECIST V1.1. Treatment group B: Presence of at least one two-dimensional measurable
lesion confirmed by imaging (CT or MRI) (either lymph nodes lesions with any long
diameter > 1.5 cm or extranodal lesions with any long diameter > 1.0 cm); for CLL
patients whose baseline imaging evaluation determined that no two-dimensional
measurable lesions, their peripheral blood monoclonal B lymphocytes should be ≥
5.0×109/L.
5. Patients must provide archival tumor samples, or a biopsy will be required if
archival tumor sample is not available. Archival tumor sample must be taken ≤ 2
years prior to screening, otherwise a fresh tumor biopsy at screening is required.
6. ECOG performance status 0 or 1
7. Adequate organ function to participate in the trial.
8. Recovery from adverse events (AEs) related to prior anticancer therapy.
Exclusion Criteria:
1. Prior treatment with any agent targeting ROR1.
2. History of Grade 4 immune-related adverse events (irAEs) or irAEs requiring
discontinuation of prior therapies.
3. Patient with primary central nervous system (CNS) malignancy or symptomatic CNS
metastases. Patients with solid tumors with CNS metastases are eligible if they do
not need to receive local radiation treatment at the discretion of investigator or
if radiation therapy for CNS metastases is completed ≥ 4 weeks prior to study
treatment.
4. Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter)
prior to study treatment.
5. Abuse on alcohol, cannabis-derived products, or other drugs.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peninsula and South Eastern Haematology and Oncology Group
Address:
City:
Frankston
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Ganju
Email:
Principal Investigator
Facility:
Name:
One Clinical Research
Address:
City:
Nedlands
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Ariyapperuma
Email:
Principal Investigator
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Quchang Ouyang
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Country:
China
Status:
Recruiting
Contact:
Last name:
Youchao Jia
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Investigator:
Last name:
Yuankai Shi
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Bengbu Medical College
Address:
City:
Bengbu
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanli Yang
Contact backup:
Last name:
Huan Zhou
Facility:
Name:
Zhujiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Sanfang Tu
Facility:
Name:
The Affiliated Tumour Hospital of Harbin Medical University
Address:
City:
Harbin
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingyuan Zhang
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Shandong
Country:
China
Status:
Recruiting
Contact:
Last name:
Zengjun Li
Contact backup:
Last name:
Yuping Sun
Facility:
Name:
Tianjin Medical University Cancer Institue & Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Lanfang Li
Start date:
March 1, 2023
Completion date:
March 31, 2026
Lead sponsor:
Agency:
EpimAb Biotherapeutics (Suzhou)Co., Ltd.
Agency class:
Industry
Source:
EpimAb Biotherapeutics (Suzhou)Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05607498
