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A Study of EMB-02 in Participants With Advanced Solid Tumors

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: NCT04618393
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai EpimAb Biotherapeutics Co., Ltd.

Brief Summary:
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Biological: EMB-02 Phase 1 Phase 2

Detailed Description:
This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Dose escalation followed by Cohort Expansion Phase at the RP2D.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Experimental: EMB-02

In Phase I part: participants enrolled in the different time will receive EMB-02 once weekly (IV) at different ascending dose levels.

In Phase II part: participants will receive EMB-02 once weekly (IV) at previously defined RP2D.

Biological: EMB-02
EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3.




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

  2. Incidence of serious adverse events (SAE) [ Time Frame: Screening up to follow-up (30 days after the last dose) ]
    Incidence of SAE.

  3. Incidence of dose interruptions [ Time Frame: Screening up to follow-up (30 days after the last dose) ]
    Incidence of dose interruptions of EMB-02 during treatment as a measure of tolerability.

  4. Dose intensity [ Time Frame: Screening up to follow-up (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 (DLTs) are based on drug related adverse events and are specifically defined in study protocol.

  6. Overall Response Rate (ORR) [ Time Frame: 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 ]
    Measured by RECIST 1.1, only applicable in Phase II part


Secondary Outcome Measures :
  1. Area under the serum concentration-time curve (AUC) of EMB-02 [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (AUC).

  2. Maximum serum concentration (Cmax) of EMB-02 [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (Cmax)

  3. Trough concentration (Ctrough) of EMB-02 [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (Ctrough)

  4. Average concentration over a dosing interval (Css, avg)of EMB-02. [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (Css, avg).

  5. Terminal half-life (T1/2) of EMB-02 [ Time Frame: Through treatment until EOT visit, expected average 6 months. ]
    Blood samples for serum PK analysis will be obtained (T1/2)

  6. Systemic clearance (CL) of EMB-02 [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (CL).

  7. Steady state volume of distribution (Vss) of EMB-02 [ Time Frame: Through treatment until EOT visit, expected average 6 months ]
    Blood samples for serum PK analysis will be obtained (Vss).

  8. Progression free survival (PFS) of EMB-02 as assessed by RECIST 1.1 [ Time Frame: 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 ]
    Preliminary anti-tumor activity of EMB-02 will be obtained (PFS).

  9. Duration of response of EMB-02 as assessed by RECIST 1.1 [ Time Frame: 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 ]
    Preliminary anti-tumor activity of EMB-02 will be obtained (DOR).

  10. Incidence and titer of anti-drug antibodies stimulated by EMB-02 [ Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose) ]
    Antibodies to EMB-02 will be assessed to evaluate potential immunogenicity.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Phase I: Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. Moreover, the disease should be measurable or evaluable per RECIST v1.1
  • Phase II Cohort A: Patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. > 1 prior therapy, including prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the disease is measurable or evaluable per RECIST v1.1
  • Archival tumor samples available for retrospective analysis or biopsy will be taken.
  • ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy > 3 Months
  • Adequate organ function to participate in the trial.
  • Recovery from adverse events (AEs) related to prior anticancer therapy.
  • Highly effective contraception

Exclusion Criteria:

  • Patients who have active autoimmune disease or history of autoimmune disease
  • History of severe irAE.
  • History of severe allergic reactions
  • Use of systemic corticosteroids.
  • Symptomatic central nervous system metastases.
  • Patients with cardiac dysfunction
  • Uncontrolled diabetes mellitus with hemoglobin A1c > 8% (via medical history)
  • Prior treatment with a LAG-3 inhibitor
  • Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
  • Prior organ or stem cell/bone marrow transplant.
  • Concurrent malignancy < 5 years prior to entry.
  • Patients with active infections.
  • Major surgery < 4 weeks or minor surgery < 2 weeks prior to study treatment
  • Live virus vaccines < 30 days prior to screening
  • Pregnant or breast-feeding females
  • Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment
  • Any other serious underlying medical conditions
  • Abuse on alcohol, cannabis- derived products or other drugs

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): NCT04618393


Contacts
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Contact: Shuqi Zeng +8618621781427 shqzeng@epimab.com
Contact: Zhongqi Wu +8613501633946 ext +8613501633946 zqwu@epimab.com

Locations
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United States, Colorado
University of Colorado Health Medical Group Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Alicia "Lisa" Deschaine, BS, CCRC, RMA    719-365-6855    Alicia.Deschaine@uchealth.org   
Contact: Elizabeth Graf, MS CCRP    719-365-6173    Elizabeth.Graf@uchealth.org   
Principal Investigator: Robert Hoyer, MD         
United States, South Carolina
Prisma Health-Upstate Recruiting
Greenville, South Carolina, United States, 29605
Contact: Fiona Davidson, BSN, RN, CTR    864-455-3737    Fiona.Davidson@prismahealth.org   
Contact: Jill Roemmich, RN    864-455-6962    Jill.Roemmich@prismahealth.org   
Principal Investigator: Ki Y Chung, MD         
Sub-Investigator: W. Jeff Edenfield, MD         
Australia, Victoria
Peninsula & South Eastern Haematology & Oncology Group (PASO) Recruiting
Frankston, Victoria, Australia, 3199
Contact: Albert, Goikhman, RN, CNC    +613 91131307    ag@paso.com.au   
Contact: Anne Marie Lobo-Davis, BSN    +613 91131310    al@paso.com.au   
Principal Investigator: Vinod Ganju, MBBS         
Sponsors and Collaborators
Shanghai EpimAb Biotherapeutics Co., Ltd.
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Responsible Party: Shanghai EpimAb Biotherapeutics Co., Ltd.
ClinicalTrials.gov Identifier: NCT04618393    
Other Study ID Numbers: EMB02X101
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai EpimAb Biotherapeutics Co., Ltd.:
Phase I/II
Bispecific antibody
PD-1
LAG-3
EMB-02
Immuno-oncology
dose escalation
cohort expansion
Neoplasms
Neoplasm Metastasis
advanced solid tumor
Additional relevant MeSH terms:
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Neoplasms