- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03797391
A Dose Escalation With Expansion Study of EMB-01 in Participants 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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Xiaodong Sun, MD
- Phone Number: +86-21-61043299
- Email: xdsun@epimab.com
Study Contact Backup
- Name: Xuemei Xie
- Phone Number: +86-21-61043299
- Email: xmxie@epimab.com
Study Locations
-
-
Guang Dong
-
Guangzhou, Guang Dong, China, 510080
- Recruiting
- Guangdong General Hospital
-
-
Shanghai
-
Shanghai, Shanghai, China, 200030
- Recruiting
- Shanghai Chest Hosptial
-
-
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Recruiting
- Barbara Ann Karmanos Cancer Institute
-
-
Ohio
-
Canton, Ohio, United States, 44718
- Recruiting
- Gabrail Cancer Center Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation-Part 1, Expansion-Part 2
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). |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD) (phase 1 only)
Time Frame: cycle 1 (1cycle = 28 days)
|
Maximum tolerated dose
|
cycle 1 (1cycle = 28 days)
|
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
|
Screening up to follow-up (30 days after the last dose)
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Serum Concentration (Cmax)
Time Frame: Through treatment discontinuation: an average of 6 months
|
Maximum Serum Concentration
|
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
|
Area Under the Plasma Concentration-Time Curve
|
Through treatment discontinuation: an average of 6 months
|
Trough Serum Concentration (Ctrough)
Time Frame: Through treatment discontinuation: an average of 6 months
|
Trough Serum Concentration
|
Through treatment discontinuation: an average of 6 months
|
Elimination half-life (t1/2)
Time Frame: Through treatment discontinuation: an average of 6 months
|
Elimination half-life
|
Through treatment discontinuation: an average of 6 months
|
Clearance (CL)
Time Frame: Through treatment discontinuation: an average of 6 months
|
Clearance
|
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
|
volume of distribution at steady state
|
Through treatment discontinuation: an average of 6 months
|
Accumulation Ratio (AR)
Time Frame: hrough treatment discontinuation: an average of 6 months
|
Accumulation Ratio
|
hrough treatment discontinuation: an average of 6 months
|
Dose Proportionality
Time Frame: Through treatment discontinuation: an average of 6 months
|
Dose Proportionality
|
Through treatment discontinuation: an average of 6 months
|
Anti-Drug Antibodies (ADA)
Time Frame: Through study completion, an average of 7 months
|
Anti-Drug Antibodies
|
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
|
Duration Of Response
|
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
|
Progression-free survival
|
Through treatment discontinuation: an average of 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacodynamic (Soluble EGFR and cMET concentration)
Time Frame: Through treatment discontinuation: an average of 6 months
|
Pharmacodynamic (Soluble EGFR and cMET concentration)
|
Through treatment discontinuation: an average of 6 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMB01X101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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