Metastatic Lung Non-Small Cell CarcinomaPhase 1/2NCT05498389
EMB-01 in Combination With Osimertinib in Patients With EGFR Mutant Lung Cancer
A Phase 1/2 study testing EMB-01 and Osimertinib in people with Metastatic Lung Non-Small Cell Carcinoma and Advanced Lung Non-Small Cell Carcinoma, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 3 sites in 2 countries.
Trial summary
This phase Ib/II trial studies the side effects and best dose of EMB-01 when given together with osimertinib in patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (advanced or metastatic) and has progressed on standard treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Lung Non-Small Cell Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- What is being tested?
- EMB-01 and Osimertinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2023to Dec 2024
- Phase
- Phase 1/2
- 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
- Age ≥ 18 years
- ECOG ≤ 1
- Patients with histologically or cytologically confirmed advanced/metastatic EGFR-mutant NSCLC
- Patients must have measurable or evaluable disease per RECIST v1.1.
- Patients must be willing to submit a blood sample for gene alteration analysis by next generation sequencing (NGS).
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- Archival tumor tissue (formalin-fixed paraffin-embedded) or a new biopsy is required prior to initiation of the study treatment for biomarker analysis.
- Phase Ib a. Patients who have progressed on/after standard therapy and no other therapies are available Phase II
- Total prior systemic therapy lines in the metastatic setting: ≤2 for Group 1, ≤3 for Group 2-3, ≤2 for Group 4.
- Patients have progressed on/after a 3rd-generation EGFR TKI for Group 1-3; Patients have progressed on/after standard of care or other available treatment for Group 4. Note: For Group 4, a patient who has refused all currently available therapy is allowed to enroll, but this must be documented in the source record.
- Group 1: Patient had a documented EGFR Exon 19del or L858R activating mutation and progressed while on osimertinib as first-line therapy in the advanced/metastatic setting.
- Group 2: Patient has an EGFR T790M-persistent mutation, having progressed on/after 2nd- or later-line osimertinib or other 3rd-generation EGFR TKI.
- Group 3: Patient had an EGFR T790M mutation, progressed on 2nd- or later-line osimertinib or another 3rd-generation EGFR TKI, and no longer harbors an EGFR T790M mutation.
- Group 4: Patient has a documented EGFR Exon20ins activating mutation.
Who cannot join
- Life expectancy < 3 months
- Any remaining AE > grade 1 as per CTCAE v5.0 from prior anticancer therapy with the exceptions of alopecia, ≤ grade 2 fatigue, ≤ grade 2 peripheral neuropathy, and grade ≤ 2 hypothyroidism stable on hormone replacement therapy. Patients who were prior treated with osimertinib or another 3rd-generation EGFR TKI, EMB-01 monotherapy, or another EGFR/cMET bispecific antibody and experienced a toxicity that led to permanent discontinuation or dose reduction will be excluded. Note: Exceptions are possible, on a case-by-case basis following discussion and mutual agreement between Investigator and Sponsor.
- Patients with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with CNS metastases are eligible if they do not need to receive local radiation treatment at the discretion of the Investigator or if radiation therapy for CNS metastases is completed ≥4 weeks prior to study treatment.
- Patients with a history of clinically significant cardiovascular disease including:
- Diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to the first dose of study treatment, or any of the following within 6 months prior to the first dose of study treatment: myocardial infraction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, may be eligible.
- Mean resting ECG QT-interval corrected according to Fridericia's formula (QTcF) > 470 milliseconds (ms) obtained from three ECGs, or clinically significant cardiac arrhythmia or electrophysiologic disease (e.g., placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate). Patients with cardiac pacemakers who are clinically stable are eligible.
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- Uncontrolled (persistent) hypertension: systolic blood pressure ≥150 mm Hg; diastolic blood pressure ≥90 mm Hg with or without anti-hypertensive medication
- Congestive heart failure (CHF)
- Pericarditis/clinically significant pericardial effusion
- Myocarditis
- Baseline left ventricular ejection fraction (LVEF) ejection fraction below the lower limit of normal (LLN), as assessed by screening echocardiogram or multigated acquisition (MUGA) scan
- Any patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives
- History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Julia Kathleen Rotow, julia_rotow@dfci.harvard.edu
Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine
Orange, California, 92868
Misako Nagasaka, nagasakm@hs.uci.edu
China1 site
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yi-Long Wu
About this study
Official title: A Phase Ib/II, Open-Label, Multi-Center Study of EMB-01 in Combination With Osimertinib in Patients With Advanced/Metastatic EGFR Mutant Lung Cancer
This phase Ib/II trial studies the side effects and best dose of EMB-01 when given together with osimertinib in patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (advanced or metastatic) and has progressed on standard treatment. EMB-01 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in this type of cancer. EMB-01 in combination with osimertinib may work better in treating patients with EGFR-mutant advanced non-small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the maximum tolerated dose (MTD) and to establish the recommended phase II dose (RP2D) of EMB-01 given in combination with osimertinib in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). (Phase Ib)
II. To preliminarily assess efficacy and further evaluate the safety and tolerability of EMB-01 plus osimertinib at the RP2D in advanced EGFR-mutant NSCLC patients who progressed on prior EGFR tyrosine kinase inhibitor (TKI) treatment. The primary endpoint is objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Phase II)
SECONDARY OBJECTIVES:
- To assess the pharmacokinetics (PK) of EMB-01 and osimertinib.
II. To assess the immunogenicity of EMB-01 and osimertinib.
III. To evaluate preliminary antitumor activity of EMB-01 and osimertinib. (Phase I)
IV. To continue to evaluate the antitumor activity of EMB-01 and osimertinib such as progression free survival, best overall response, duration of response, and clinical benefit rate. (Phase II)
EXPLORATORY OBJECTIVES:
- To explore the relationships between pharmacokinetics, biomarkers, adverse event profiles, and anticancer activity of EMB-01 combined with osimertinib.
OUTLINE: This is a phase Ib, dose-escalation study of EMB-01 and osimertinib followed by a phase II study.
Patients receive EMB-01 intravenously (IV) weekly. Patients also receive osimertinib orally (PO) once daily (QD) on days 1-28. Treatment cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Being tested
- EMB-01, Osimertinib
- Keywords
- NSCLC, Non-small cell lung cancer, EGFR, EMB01, cMET, T790M, bispecific, Osimertinib, TKI-resistant, EGFR exon 20 insertion
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMB-01Drug
Also called FIT-013a
EMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET).
OsimertinibDrug
Also called Tagrisso, Mereletinib, AZD-9291, AZD9291
Osimertinib is an approved, third-generation EGFR tyrosine kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation (Phase Ib), Part 2 Dose Expansion (Phase II) | Experimental | In Part 1 dose escalation, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached, or all planned doses are administered.
In Part 2 dose expansion, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28 at the recommended phase II dose (RP2D) regimen. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: EMB-01; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of EMB-01 and osimertinib (Phase Ib only)
Measured: Up to 28 days
Rate of Adverse Events (AE) and Serious Adverse Events (SAE)
Adverse events and serious adverse events as assessed by CTCAE v5.0
Measured: From enrollment up to 30 days after the last dose
Recommended phase II dose (RP2D) of EMB-01 and osimertinib (Phase Ib)
Measured: Up to 28 days
Objective Response Rate (ORR) (Phase II only)
Objective response rate, measured by RECIST 1.1
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Secondary outcomes (8)
Best Overall Response (BOR)
Best overall response as assessed by RECIST v1.1
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Duration of Response (DoR)
Duration of response as assessed by RECIST v1.1
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Clinical Benefit Rate (CBR)
Clinical benefit rate as assessed by RECIST v1.1
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Progression Free Survival (PFS)
Progression free survival as assessed by RECIST v1.1
Measured: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Cmax
Maximum measured plasma concentration of EMB-01
Measured: From predose up to 3 months after first dose
Tmax
Time to maximum plasma concentration
Measured: From predose up to 30 days after the last dose
Ctrough
Minimum serum concentration
Measured: From predose up to 30 days after the last dose
Immunogenicity profile of EMB-01
Blood samples will be collected from patients post-treatment for assessment of the presence of anti-drug antibodies and neutralizing antibodies.
Measured: From predose up to 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 posted12 Aug 2022
- Study startJun 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Lung Non-Small Cell CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498389
- Sponsor's protocol ID
- EMB01X202
- Status last verified
- May 2023
- First submitted
- 28 Jun 2022
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Open-Label, Multi-Center Study of EMB-01 in Combination With Osimertinib in Patients With Advanced/Metastatic EGFR Mutant Lung Cancer
- ClinicalTrials.gov ID
- NCT05498389
- Acronym / sponsor ID
- EMB01X202
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
- Keywords
- NSCLC, Non-small cell lung cancer, EGFR, EMB01, cMET, T790M, bispecific, Osimertinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Aug 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 phase Ib/II trial studies the side effects and best dose of EMB-01 when given together with osimertinib in patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (advanced or metastatic) and has progressed on standard treatment. EMB-01 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth in this type of cancer. EMB-01 in combination with osimertinib may work better in treating patients with EGFR-mutant advanced non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the maximum tolerated dose (MTD) and to establish the recommended phase II dose (RP2D) of EMB-01 given in combination with osimertinib in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC). (Phase Ib)
II. To preliminarily assess efficacy and further evaluate the safety and tolerability of EMB-01 plus osimertinib at the RP2D in advanced EGFR-mutant NSCLC patients who progressed on prior EGFR tyrosine kinase inhibitor (TKI) treatment. The primary endpoint is objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. (Phase II)
SECONDARY OBJECTIVES:
- To assess the pharmacokinetics (PK) of EMB-01 and osimertinib.
II. To assess the immunogenicity of EMB-01 and osimertinib.
III. To evaluate preliminary antitumor activity of EMB-01 and osimertinib. (Phase I)
IV. To continue to evaluate the antitumor activity of EMB-01 and osimertinib such as progression free survival, best overall response, duration of response, and clinical benefit rate. (Phase II)
EXPLORATORY OBJECTIVES:
- To explore the relationships between pharmacokinetics, biomarkers, adverse event profiles, and anticancer activity of EMB-01 combined with osimertinib.
OUTLINE: This is a phase Ib, dose-escalation study of EMB-01 and osimertinib followed by a phase II study.
Patients receive EMB-01 intravenously (IV) weekly. Patients also receive osimertinib orally (PO) once daily (QD) on days 1-28. Treatment cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation (Phase Ib), Part 2 Dose Expansion (Phase II) | Experimental | Drug: EMB-01, Drug: OsimertinibIn Part 1 dose escalation, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached, or all planned doses are administered. In Part 2 dose expansion, patients will receive EMB-01 IV once weekly and osimertinib PO QD on days 1-28 at the recommended phase II dose (RP2D) regimen. The treatment cycle repeats every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 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
- Age ≥ 18 years
- ECOG ≤ 1
- Patients with histologically or cytologically confirmed advanced/metastatic EGFR-mutant NSCLC
- Patients must have measurable or evaluable disease per RECIST v1.1.
Key exclusion criteria (13 listed)
- Life expectancy < 3 months
- Any remaining AE > grade 1 as per CTCAE v5.0 from prior anticancer therapy with the exceptions of alopecia, ≤ grade 2 fatigue, ≤ grade 2 peripheral neuropathy, and grade ≤ 2 hypothyroidism stable on hormone replacement therapy. Patients who were prior treated with osimertinib or another 3rd-generation EGFR TKI, EMB-01 monotherapy, or another EGFR/cMET bispecific antibody and experienced a toxicity that led to permanent discontinuation or dose reduction will be excluded. Note: Exceptions are possible, on a case-by-case basis following discussion and mutual agreement between Investigator and Sponsor.
- Patients with primary central nervous system (CNS) malignancy or symptomatic CNS metastases. Patients with CNS metastases are eligible if they do not need to receive local radiation treatment at the discretion of the Investigator or if radiation therapy for CNS metastases is completed ≥4 weeks prior to study treatment.
- Patients with a history of clinically significant cardiovascular disease including:
- History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis
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-01Also: FIT-013aEMB-01 is a bispecific antibody against epidermal growth factor receptor (EGFR) and the receptor tyrosine kinase Met (cMET). | Drug | Part 1 Dose Escalation (Phase Ib), Part 2 Dose Expansion (Phase II) |
| OsimertinibAlso: Tagrisso, Mereletinib, AZD-9291, AZD9291Osimertinib is an approved, third-generation EGFR tyrosine kinase inhibitor | Drug | Part 1 Dose Escalation (Phase Ib), Part 2 Dose Expansion (Phase II) |
Primary outcome
Maximum tolerated dose (MTD) of EMB-01 and osimertinib (Phase Ib only)
Time frame: Up to 28 days
Rate of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: From enrollment up to 30 days after the last dose
Adverse events and serious adverse events as assessed by CTCAE v5.0
Recommended phase II dose (RP2D) of EMB-01 and osimertinib (Phase Ib)
Time frame: Up to 28 days
Objective Response Rate (ORR) (Phase II only)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first, up to 2 years
Objective response rate, measured by RECIST 1.1
8 secondary outcomes
Best Overall Response (BOR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Duration of Response (DoR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Clinical Benefit Rate (CBR)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Progression Free Survival (PFS)
Time frame: From first dose until the date of first documented progression or date of death from any cause, whichever comes first; up to 2 years
Cmax
Time frame: From predose up to 3 months after first dose
Tmax
Time frame: From predose up to 30 days after the last dose
Ctrough
Time frame: From predose up to 30 days after the last dose
Immunogenicity profile of EMB-01
Time frame: From predose up to 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 1 Jun 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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EMB-01 and Osimertinib in people with Metastatic Lung Non-Small Cell Carcinoma and Advanced Lung Non-Small Cell Carcinoma, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 3 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 14 inclusion and 13 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 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Xiaodong Sun, MD (+86-21-61043299, CT.info@epimab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of EMB-01 and osimertinib (Phase Ib only) (time frame: Up to 28 days). The study lists 4 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 1 Jun 2023.