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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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