The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05607498
Recruitment Status : Recruiting
First Posted : November 7, 2022
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
EpimAb Biotherapeutics (Suzhou)Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Solid Tumors Relapse/Refractory Lymphoma Drug: EMB07 Phase 1

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: EMB-07-Patients with solid tumor
Patients with solid tumor will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered.
 Drug: EMB07
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI
Experimental: EMB07-Patients with lymphoma
Patients with lymphoma will receive intravenous infusions of EMB-07 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is reached or all planned doses are administered.
 Drug: EMB07
EMB07 is a MAT-Fab bispecific antibody against CD3 and RORI


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence and severity of adverse events as assessed by CTCAE V5.0. [ Time Frame: Screening up to 30 days after the last dose. ]
    Incidence and severity of AE.

  2. Incidence of serious adverse events (SAE). [ Time Frame: Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related. ]
    Incidence of SAE.

  3. Incidence of dose interruptions. [ Time Frame: Screening up to 30 days after the last dose. ]
    Incidence of dose interruptions of EMB-07 during treatment as a measure of tolerability.

  4. Dose intensity. [ Time Frame: Screening up to 30 days after the last dose. ]
    Actual amount of drug taken by patients divided by the planned amount.

  5. The incidence of DLTs during the first cycle of treatment. [ Time Frame: First infusion to the end of cycle 1. (each cycle is 28 days). ]
    The dose limiting toxicities are based on drug related adverse events and are specifically defined in study protocol.


Secondary Outcome Measures :
  1. Overall response rate. [ Time Frame: From the date of dosing untill the date of first documented progression or date of death from any casue, whichever case first, expected average 6 months. ]
    Overall response rate measured by RECIST V1.1, iWCLL-2018, Lugano 2014

  2. Area under the serum concentration-time curve (AUC) of EMB-07. [ Time Frame: Through treatment until EOT visit, expected average 6 months. ]
    Blood samples for serum PK analysis will be obtained (AUC).

  3. Maximum serum concentration (Cmax) of EMB-07. [ Time Frame: Through treatment until EOT visit, expected average 6 months. ]
    Blood samples for serum PK analysis will be obtained (Cmax).

  4. Trough concentration (Ctrough) of EMB-07. [ Time Frame: Through treatment until EOT visit, expected average 6 months. ]
    Blood samples for serum PK analysis will be obtained (Ctrough).

  5. Average concentration over a dosing interval (Css, avg) of EMB-07. [ Time Frame: Through treatment until EOT visit, expected average 6 months. ]
    Blood samples for serum PK analysis will be obtained (Css,avg).

  6. Terminal half-life (T1/2) of EMB-07. [ Time Frame: Through treatment until EOT visit, expected average 6 months. ]
    Blood samples for serum PK analysis will be obtained (T1/2).

  7. Systemic clearance (CL) of EMB-07. [ Time Frame: Through treatment until EOT visit, expected average 6 months. ]
    Blood samples for serum PK analysis will be obtained (CL).

  8. Steady state volume of distribution (Vss) of EMB-07. [ Time Frame: Through treatment until EOT visit, expected average 6 months. ]
    Blood samples for serum PK analysis will be obtained (Vss).

  9. Progression free survival (PFS) of EMB-07 as assessed by RECIST 1.1, iWCLL-2018, Lugano 2014 [ Time Frame: Through treatment discontinuation: an average of 6 months ]
    From the date of dosing until the date of first documented progression or date of death from any cause, whichever came first, expected average 6 months.

  10. Incidence and titer of anti-drug antibodies stimulated by EMB-07. [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    Antibodies to EMB-07 will be assessed to evaluate potential immunogenicity.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05607498


Contacts
Layout table for location contacts
Contact: Xiaodong Sun +8618512158506 xdsun@epimab.com
Contact: Xuemei Xie +8615721294395 xmxie@epimab.com

Locations
Layout table for location information
Australia, Victoria
Peninsula and South Eastern Haematology and Oncology Group Recruiting
Frankston, Victoria, Australia
Principal Investigator: Ganju         
Australia, Western Australia
One Clinical Research Recruiting
Nedlands, Western Australia, Australia
Principal Investigator: Ariyapperuma         
China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China
Contact: Quchang Ouyang         
China
Affiliated Hospital of Hebei University Recruiting
Baoding, China
Contact: Youchao Jia         
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, China
Principal Investigator: Yuankai Shi         
The First Affiliated Hospital of Bengbu Medical College Recruiting
Bengbu, China
Contact: Yanli Yang         
Contact: Huan Zhou         
Zhujiang Hospital of Southern Medical University Recruiting
Guangzhou, China
Contact: Sanfang Tu         
The Affiliated Tumour Hospital of Harbin Medical University Recruiting
Harbin, China
Contact: Qingyuan Zhang         
Shandong Cancer Hospital Recruiting
Shandong, China
Contact: Zengjun Li         
Contact: Yuping Sun         
Tianjin Medical University Cancer Institue & Hospital Recruiting
Tianjin, China
Contact: Lanfang Li         
Sponsors and Collaborators
EpimAb Biotherapeutics (Suzhou)Co., Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: EpimAb Biotherapeutics (Suzhou)Co., Ltd.
ClinicalTrials.gov Identifier: NCT05607498    
Other Study ID Numbers: EMB07X101
First Posted: November 7, 2022    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EpimAb Biotherapeutics (Suzhou)Co., Ltd.:
Phase I
Bispecific antibody
CD3
ROR1
 EMB07
Dose escalation
Advanced/Metastatic Solid Tumors
Relapse/Refractory Lymphoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Recurrence
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes