NeoplasmsPhase 1/2NCT03797391
A Dose Escalation With Expansion Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors
A Phase 1/2 study testing EMB-01 in people with Neoplasms and Neoplasm Metastasis, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 5 sites in 2 countries.
Trial summary
First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients with Advanced/Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Neoplasm Metastasis, Non-Small-Cell Lung Cancer
- What is being tested?
- EMB-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 13 Dec 2018to 15 Jan 2026
- 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
- Molecular Pre-screening Inclusion criteria (Phase II only)
- The patient must sign the molecular pre-screening Inform Consent to allow for the molecular pre-screening process. All patients must have documented evidence of EGFR and/or cMet aberrations.
- Screening Inclusion Criteria
- Able to understand and willing to sign the Informed Consent Form (ICF).
- Histologically/cytologically confirmed advanced/metastatic solid tumors with measurable disease [Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]:
- Phase I: advanced/metastatic solid tumors including but not limited to NSCLC, colorectal cancer, gastric cancer and liver cancer refractory to standard therapy or for which no standard therapy is available or accessible.
Show all 15Show fewer
- Phase II: Advanced/metastatic NSCLC Patients have confirmed EGFR mutant and/or cMET aberration, and have progressed after standard treatment (including platinum-based therapy) or are intolerant to standard treatment. Additionally, patients with T790M mutation have received FDA/Health Authority approved therapies (if accessible) for this indication (i.e., osimertinib) and have progressed or became intolerant.
- A patient who has refused all currently available therapy is allowed to enroll, but must be documented in the source record.
- Must have adequate organ function.
- Regarding prior anti-tumor therapy:
- Must have stopped treatment at least 4 weeks or within 5 half-lives.
- Generalized radiation therapy must have stopped 3 weeks before first dose of EMB 01, or local radiotherapy or radiation therapy for bone metastases must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before first dose of EMB-01.
- Patients must have recovered to ≤Grade 1 from the adverse effects of such above treatment before beginning study treatment.
- Female patient with fertility or male patient whose partner has fertility should use one or more contraceptive methods for contraception starting from screening period and continue throughout the study treatment and for 3 months.
- ECOG score 0 or 1 for phase I, and ≤2 for phase II.
Who cannot join
- Molecular Pre-screening Exclusion Criteria (Phase II only)
- Subject who meets any of the follow criteria can't be proceeded to clinical screening:
- Patients who are unwilling to sign the molecular pre-screening ICF.
- Patients for whom local EGFR and/or cMET data or the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.
- Screening Exclusion Criteria
- Life expectancy < 3 months.
Show all 10Show fewer
- Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases.
- Pregnant or nursing females.
- Subjects who have had major surgery within 28 days prior to screening.
- Serious underlying medical conditions, including but not limited to un-controlled hypertension, other cardiovascular disease or diabetes, ongoing or active infection, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere the compliance with study treatment.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Gabrail Cancer Center Research
Canton, Ohio, 44718
- Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
China2 sites, 2 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
- Recruiting
Shanghai Chest Hosptial
Shanghai, Shanghai Municipality, 200030
About this study
Official title: First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Solid Tumors
First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients with Advanced/Metastatic Solid Tumors
Read the detailed description
This is a first-in-human (FIH), open-label, Phase I/II study of EMB-01, a bispecific Epidermal growth factor receptor (EGFR) and c-Mesenchymal-Epithelial Transition (cMet) antibody, in patients with advanced solid tumors who have progressed on available standard therapies or for which no standard therapy exists. The study consists of two parts: Phase I (dose escalation) and Phase II (cohort expansion). The study is planning to recruit tentatively 33-66 subjects with advanced/metastatic solid tumors in phase I and approximately 42-120 subjects with EGFR mutant and/or cMET aberrated NSCLC who have progressed on or are intolerant to standard treatment(s) (including platinum-based therapy) will be enrolled at the RP2D(s) in phase II part of the study. In phase II, patients will be assigned to five groups according to their molecular status at baseline. The trial will consist of molecular pre-screening period (Phase II only), clinical screening period (-28 to -1 days), treatment cycles (each cycle is 28 days, maximum up to 2 years), and safety follow-up period (30 days after the last dose).
- Conditions
- Neoplasms, Neoplasm Metastasis, Non-Small-Cell Lung Cancer
- Being tested
- EMB-01
- Keywords
- Human Bispecific antibody,, Epidermal Growth Factor Receptor (EGFR),, c-Mesenchymal-Epithelial Transition (cMet),, Neoplasms, Neoplasm Metastasis,, Non-Small-Cell Lung Cancer (NSCLC), First-in-human,, EMB-01, Tyrosine Kinase Inhibitor (TKI) Resistant
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung
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
In part 1, patients will receive intravenous infusions of EMB01 weekly (QW). 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, participants will receive intravenous infusion of EMB-01 at RP2D
The duration of each treatment cycle in both part 1 and part 2 is 28 days (4 weeks).
Participants may continue to receive study drug until discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation-Part 1, Expansion-Part 2 | Experimental | In part 1, escalating dose cohort, patients will receive intravenous infusions of EMB-01 weekly (QW). The duration of each treatment cycle is 28 days (4 weeks). 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, participants will receive intravenous infusion of EMB-01 at the recommended Phase II dose (RP2D) regimen(s) once weekly. The duration of each treatment cycle is 28 days (4 weeks). Receives: Drug: EMB-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) (phase 1 only)
Maximum tolerated dose
Measured: cycle 1 (1cycle = 28 days)
Adverse Events (AEs), and Serious Adverse Events (SAEs)
Adverse Events, and Serious Adverse Events
Measured: Screening up to follow-up (30 days after the last dose)
Overall Response Rate (ORR) (phase 2 only)
Overall Response Rate
Measured: From the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Secondary outcomes (11)
Maximum Serum Concentration (Cmax)
Maximum Serum Concentration
Measured: Through treatment discontinuation: an average of 6 months
Area Under the Plasma Concentration-Time Curve (AUC)
Area Under the Plasma Concentration-Time Curve
Measured: Through treatment discontinuation: an average of 6 months
Trough Serum Concentration (Ctrough)
Trough Serum Concentration
Measured: Through treatment discontinuation: an average of 6 months
Elimination half-life (t1/2)
Elimination half-life
Measured: Through treatment discontinuation: an average of 6 months
Clearance (CL)
Clearance
Measured: Through treatment discontinuation: an average of 6 months
Volume of distribution at steady state (Vss)
volume of distribution at steady state
Measured: Through treatment discontinuation: an average of 6 months
Accumulation Ratio (AR)
Accumulation Ratio
Measured: hrough treatment discontinuation: an average of 6 months
Dose Proportionality
Dose Proportionality
Measured: Through treatment discontinuation: an average of 6 months
Anti-Drug Antibodies (ADA)
Anti-Drug Antibodies
Measured: Through study completion, an average of 7 months
Duration Of Response (DOR)
Duration Of Response
Measured: From the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Progression-Free Survival (PFS)
Progression-free survival
Measured: Through treatment discontinuation: an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start13 Dec 2018
- Primary completion14 Mar 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Model description
- Dose escalation followed by Protocol at 100mg, 200mg, 350mg, 500mg, 700mg, 900mg, 1200mg, 1600mg, 2100mg, 2700mg and 3000mg .
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797391
- Sponsor's protocol ID
- EMB01X101
- Status last verified
- May 2023
- First submitted
- 26 Dec 2018
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- 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 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03797391
- Acronym / sponsor ID
- EMB01X101
- Conditions
- Neoplasms, Neoplasm Metastasis, Non-Small-Cell Lung Cancer
- Keywords
- Human Bispecific antibody,, Epidermal Growth Factor Receptor (EGFR),, c-Mesenchymal-Epithelial Transition (cMet),, Neoplasms, Neoplasm Metastasis,, Non-Small-Cell Lung Cancer (NSCLC), First-in-human,, EMB-01, Tyrosine Kinase Inhibitor (TKI) Resistant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 9 Jan 2019 (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.
First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients with Advanced/Metastatic Solid Tumors
Detailed description
This is a first-in-human (FIH), open-label, Phase I/II study of EMB-01, a bispecific Epidermal growth factor receptor (EGFR) and c-Mesenchymal-Epithelial Transition (cMet) antibody, in patients with advanced solid tumors who have progressed on available standard therapies or for which no standard therapy exists. The study consists of two parts: Phase I (dose escalation) and Phase II (cohort expansion). The study is planning to recruit tentatively 33-66 subjects with advanced/metastatic solid tumors in phase I and approximately 42-120 subjects with EGFR mutant and/or cMET aberrated NSCLC who have progressed on or are intolerant to standard treatment(s) (including platinum-based therapy) will be enrolled at the RP2D(s) in phase II part of the study. In phase II, patients will be assigned to five groups according to their molecular status at baseline. The trial will consist of molecular pre-screening period (Phase II only), clinical screening period (-28 to -1 days), treatment cycles (each cycle is 28 days, maximum up to 2 years), and safety follow-up period (30 days after the last dose).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation followed by Protocol at 100mg, 200mg, 350mg, 500mg, 700mg, 900mg, 1200mg, 1600mg, 2100mg, 2700mg and 3000mg .
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation-Part 1, Expansion-Part 2 | Experimental | Drug: EMB-01In part 1, escalating dose cohort, patients will receive intravenous infusions of EMB-01 weekly (QW). The duration of each treatment cycle is 28 days (4 weeks). 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, participants will receive intravenous infusion of EMB-01 at the recommended Phase II dose (RP2D) regimen(s) once weekly. The duration of each treatment cycle is 28 days (4 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Molecular Pre-screening Inclusion criteria (Phase II only)
- The patient must sign the molecular pre-screening Inform Consent to allow for the molecular pre-screening process. All patients must have documented evidence of EGFR and/or cMet aberrations.
- Screening Inclusion Criteria
- Able to understand and willing to sign the Informed Consent Form (ICF).
- Histologically/cytologically confirmed advanced/metastatic solid tumors with measurable disease [Response Evaluation Criteria in Solid Tumors (RECIST) v1.1]:
Key exclusion criteria (10 listed)
- Molecular Pre-screening Exclusion Criteria (Phase II only)
- Patients who are unwilling to sign the molecular pre-screening ICF.
- Patients for whom local EGFR and/or cMET data or the results of central laboratory testing do not meet the molecular pre-screening inclusion criteria.
- Screening Exclusion Criteria
- Life expectancy < 3 months.
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-013aIn part 1, patients will receive intravenous infusions of EMB01 weekly (QW). 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, participants will receive intravenous infusion of EMB-01 at RP2D The duration of each treatment cycle in both part 1 and part 2 is 28 days (4 weeks). Participants may continue to receive study drug until discontinuation criteria are met. | Drug | Dose Escalation-Part 1, Expansion-Part 2 |
Primary outcome
Maximum tolerated dose (MTD) (phase 1 only)
Time frame: cycle 1 (1cycle = 28 days)
Maximum tolerated dose
Adverse Events (AEs), and Serious Adverse Events (SAEs)
Time frame: Screening up to follow-up (30 days after the last dose)
Adverse Events, and Serious Adverse Events
Overall Response Rate (ORR) (phase 2 only)
Time frame: From the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Overall Response Rate
11 secondary outcomes
Maximum Serum Concentration (Cmax)
Time frame: Through treatment discontinuation: an average of 6 months
Area Under the Plasma Concentration-Time Curve (AUC)
Time frame: Through treatment discontinuation: an average of 6 months
Trough Serum Concentration (Ctrough)
Time frame: Through treatment discontinuation: an average of 6 months
Elimination half-life (t1/2)
Time frame: Through treatment discontinuation: an average of 6 months
Clearance (CL)
Time frame: Through treatment discontinuation: an average of 6 months
Volume of distribution at steady state (Vss)
Time frame: Through treatment discontinuation: an average of 6 months
Accumulation Ratio (AR)
Time frame: hrough treatment discontinuation: an average of 6 months
Dose Proportionality
Time frame: Through treatment discontinuation: an average of 6 months
Anti-Drug Antibodies (ADA)
Time frame: Through study completion, an average of 7 months
Duration Of Response (DOR)
Time frame: From the date fo dosing until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Progression-Free Survival (PFS)
Time frame: Through treatment discontinuation: an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Individual participant dataSharing planned: No
Related trials for Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
5 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 in people with Neoplasms and Neoplasm Metastasis, run by Shanghai EpimAb Biotherapeutics Co., Ltd. at 5 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 15 inclusion and 10 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 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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, xdsun@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) (phase 1 only) (time frame: cycle 1 (1cycle = 28 days)). The study lists 3 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 31 May 2023.