Advanced Solid TumorPhase 1NCT05263180
A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.
A Phase 1 study testing EMB-09 in people with Advanced Solid Tumor, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- EMB-09
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Jul 2022to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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).
- Patients who have failed (progressed on, or are intolerant of) standard therapies or no available standard treatment
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites, 3 recruiting
- Recruiting
Peninsula and South Eastern Haematology & Oncology Group
Frankston
Vinod Ganju
- Recruiting
GenesisCareNorthShore
Leonards Hill
Adrian Lee
- Recruiting
Blacktown Hospital
Sydney
Adnan Nagrial, Adnan.Nagrial@health.nsw.gov.au
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- EMB-09
- Keywords
- Phase I, Bispecific antibody, OX40, PD-L1, EMB-09, Immuno-oncology, dose escalation, cohort expansion, advanced solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB-09Biological
EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: EMB-09 | Experimental | Participants enrolled at different time will receive EMB-09 once a week (IV) at different ascending dose levels. Receives: Biological: EMB-09 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events as assessed by CTCAE V5.0
Incidence and severity of AE.
Measured: Screening up to 30 days after the last dose.
Incidence of serious adverse events. (SAE)
Incidence of SAE.
Measured: 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.
Incidence of dose interruptions of EMB-09 during treatment as a measure of tolerability.
Measured: Screening up to 30 days after the las dose.
Dose intensity.
Actual amount of drug taken by patients divided by the planned amount.
Measured: Screening up to 30 days after the last dose.
The incidence of DLTs during the first cycle of treatment.
The dose limiting toxicities are based on drug related adverse events and are specifically defined in study protocol.
Measured: First infusion to the end of cycle 1. (each cycle is 28 days)
Secondary outcomes (10)
Overall response rate
Measured by RECIST 1.1.
Measured: 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.
Area under the serum concentration-time curve (AUC) of EMB-09
Blood samples for serum PK analysis will be obtained (AUC).
Measured: Through treatment until EOT visit, expected average 6 months
Maximum serum concentration (Cmax) of EMB-09
Blood samples for serum PK analysis will be obtained (Cmax)
Measured: Through treatment until EOT visit, expected average 6 months
Trough concentration (Ctrough) of EMB-09
Blood samples for serum PK analysis will be obtained (Ctrough)
Measured: Through treatment until EOT visit, expected average 6 months
Average concentration over a dosing interval (Css, avg)of EMB-09.
Blood samples for serum PK analysis will be obtained (Css, avg).
Measured: Through treatment until EOT visit, expected average 6 months
Terminal half-life (T1/2) of EMB-09
Blood samples for serum PK analysis will be obtained (T1/2)
Measured: Through treatment until EOT visit, expected average 6 months
Systemic clearance (CL) of EMB-09
Blood samples for serum PK analysis will be obtained (CL).
Measured: Through treatment until EOT visit, expected average 6 months
Steady state volume of distribution (Vss) of EMB-09
Blood samples for serum PK analysis will be obtained (Vss).
Measured: Through treatment until EOT visit, expected average 6 months
Progression free survival (PFS) of EMB-09 as assessed by RECIST 1
Preliminary anti-tumor activity of EMB-09 will be obtained. (DOR)
Measured: 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
Antibodies to EMB-09 will be assessed to evaluate potential immunogenicity.
Measured: Up to End of Treatment Follow Up Period (30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start25 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Dose escalation followed by Cohort Expansion Phase at the RP2D.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263180
- Sponsor's protocol ID
- EMB09X101
- Status last verified
- Oct 2023
- First submitted
- 22 Feb 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05263180
- Acronym / sponsor ID
- EMB09X101
- Conditions
- Advanced Solid Tumor
- Keywords
- Phase I, Bispecific antibody, OX40, PD-L1, EMB-09, Immuno-oncology, dose escalation, cohort expansion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Dose escalation followed by Cohort Expansion Phase at the RP2D.
| Arm | Type | Receives |
|---|---|---|
| Experimental: EMB-09 | Experimental | Biological: EMB-09Participants enrolled at different time will receive EMB-09 once a week (IV) at different ascending dose levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMB-09EMB-09 is a FIT-Ig® bispecific antibody against PD-L1 and OX40. | Biological | Experimental: EMB-09 |
Primary outcome
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.
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.
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.
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.
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.
10 secondary outcomes
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.
Area under the serum concentration-time curve (AUC) of EMB-09
Time frame: 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
Trough concentration (Ctrough) of EMB-09
Time frame: 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
Terminal half-life (T1/2) of EMB-09
Time frame: 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
Steady state volume of distribution (Vss) of EMB-09
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EMB-09 in people with Advanced Solid Tumor, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuqi Zeng, MD. (+86-21-61043299, shqzeng@epimab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events as assessed by CTCAE V5.0 (time frame: Screening up to 30 days after the last dose.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.