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

March 28, 2022 updated by: Shanghai EpimAb Biotherapeutics Co., Ltd.

A Phase I/II Trial of EMB-02, a Bi-specific Antibody Against PD-1 and LAG-3, in Patients With Advanced Solid Tumors

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

43

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zhongqi Wu
  • Phone Number: +8613501633946 +8613501633946
  • Email: zqwu@epimab.com

Study Locations

  • Australia
    • New South Wales
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Peninsula & South Eastern Haematology & Oncology Group (PASO)
        • Contact:
          • Albert, Goikhman, RN, CNC
          • Phone Number: +613 91131307
          • Email: ag@paso.com.au
        • Contact:
          • Anne Marie Lobo-Davis, BSN
          • Phone Number: +613 91131310
          • Email: al@paso.com.au
        • Principal Investigator:
          • Vinod Ganju, MBBS
  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • University of Colorado Health Medical Group
        • Principal Investigator:
          • Robert Hoyer, MD
        • Contact:
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health-Upstate
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ki Y Chung, MD
        • Sub-Investigator:
          • W. Jeff Edenfield, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening up to follow-up (30 days after the last dose)
Incidence of serious adverse events (SAE)
Time Frame: Screening up to follow-up (30 days after the last dose)
Incidence of SAE.
Screening up to follow-up (30 days after the last dose)
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.
Screening up to follow-up (30 days after the last dose)
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.
Screening up to follow-up (30 days after the last dose)
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.
First infusion to the end of Cycle 1 (each cycle is 28 days)
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Through treatment until EOT visit, expected average 6 months
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)
Through treatment until EOT visit, expected average 6 months
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)
Through treatment until EOT visit, expected average 6 months
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).
Through treatment until EOT visit, expected average 6 months
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)
Through treatment until EOT visit, expected average 6 months.
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).
Through treatment until EOT visit, expected average 6 months
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).
Through treatment until EOT visit, expected average 6 months
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).
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
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).
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
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.
Up to End of Treatment Follow Up Period (30 days after the last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai EpimAb Biotherapeutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

October 18, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMB02X101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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