A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.

October 16, 2023 updated by: Shanghai EpimAb Biotherapeutics Co., Ltd.

A First-in-human, Phase I Trial of EMB-09, a Bispecific Antibody Targeting PD-L1 and OX-40 in Patients With Advanced or Metastatic Solid Tumors

This study is to evaluate the safety and tolerability of EMB-09 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-09 will also be assessed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a phase I, 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 for EMB-09 in patient with advanced or metastatic solid tumors. Pharmacokinetics,pharmacodynamics, immunogenicity and response will also be assessed.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • 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

Study Locations

  • Australia
      • Frankston, Australia
        • Recruiting
        • Peninsula and South Eastern Haematology & Oncology Group
        • Contact:
          • Vinod Ganju
      • Leonards Hill, Australia
        • Recruiting
        • GenesisCareNorthShore
        • Contact:
          • Adrian Lee
      • Sydney, Australia
  • China
      • Shanghai, China
        • Recruiting
        • FUSCC
        • Contact:
          • Jian Zhang

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

Description

Inclusion Criteria:

  • 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.

  • Phase I subjects:

    1. Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors including but not limited to melanoma, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), hepatocellular carcinoma (HCC), gastric cancer (GC), endometrium cancer (EC), ovarian cancer (OC), renal cell carcinoma (RCC) and small cell lung cancer (SCLC), colorectal cancer (CRC).
    2. Patients who have failed (progressed on, or are intolerant of) standard therapies or no available standard treatment
    3. Measurable or evaluable disease per RECIST v1.1.
  • Patients must provide archival tumor, or a fresh tumor 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.
  • ECOG performance status 0 or 1; 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 TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR), CD40.
  • Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
  • Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, or organizing pneumonia.
  • 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 of 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: Experimental: EMB-09
Participants enrolled at different time will receive EMB-09 once a week (IV) at different ascending dose levels.
Biological: EMB-09
EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Screening up to 30 days after the last dose.
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.
Screening up to 30 days after the last dose.
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.
Screening up to 30 days after the last dose, or beyond 30 days if SAE is confirmed to be treatment related.
Incidence of dose interruptions.
Time Frame: Screening up to 30 days after the las dose.
Incidence of dose interruptions of EMB-09 during treatment as a measure of tolerability.
Screening up to 30 days after the las 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 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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the serum concentration-time curve (AUC) of EMB-09
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-09
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-09
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-09.
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-09
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-09
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-09
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-09 as assessed by RECIST 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-09 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-09
Time Frame: Up to End of Treatment Follow Up Period (30 days after the last dose
Antibodies to EMB-09 will be assessed to evaluate potential immunogenicity.
Up to End of Treatment Follow Up Period (30 days after the last dose
Overall response rate
Time Frame: From the date of dosing until the date of first documented progression or date of death from any cause, whichever case first, expected average 6 months.
Measured by RECIST 1.1.
From the date of dosing until the date of first documented progression or date of death from any cause, whichever case first, expected average 6 months.

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)

July 25, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

February 22, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMB09X101

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

No

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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