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A Dose Escalation Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT03797391
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Shanghai EpimAb Biotherapeutics Co., Ltd.

Brief Summary:
First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients with Advanced/Metastatic Solid Tumors

Condition or disease Intervention/treatment Phase
Neoplasms Neoplasm Metastasis Non-Small-Cell Lung Cancer Drug: EMB-01 Phase 1 Phase 2

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 about 40 patients with EGFR mutant Non-Small Cell Lung Cancer (NSCLC) in Phase II. Both parts consist of screening period (-28 to -1 days), treatment cycles (each cycle is 28 days), and follow-up period (30 days safety follow up and disease progression follow up).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Solid Tumors
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : September 9, 2021
Estimated Study Completion Date : September 9, 2021

Resource links provided by the National Library of Medicine


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). Participants may continue to receive study drug until discontinuation criteria are met. 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).

Drug: EMB-01

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 Name: FIT-013a




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) (phase 1 only) [ Time Frame: cycle 1 (1cycle = 28 days) ]
    Maximum tolerated dose

  2. 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

  3. 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

  4. Duration Of Response (DOR) (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 ]
    Duration Of Response

  5. Progression-Free Survival (PFS) (phase 2 only) [ Time Frame: Through treatment discontinuation: an average of 6 months ]
    Progression-free survival


Secondary Outcome Measures :
  1. Maximum Serum Concentration (Cmax) [ Time Frame: Through treatment discontinuation: an average of 6 months ]
    Maximum Serum Concentration

  2. 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

  3. Trough Serum Concentration (Ctrough) [ Time Frame: Through treatment discontinuation: an average of 6 months ]
    Trough Serum Concentration

  4. Elimination half-life (t1/2) [ Time Frame: Through treatment discontinuation: an average of 6 months ]
    Elimination half-life

  5. Clearance (CL) [ Time Frame: Through treatment discontinuation: an average of 6 months ]
    Clearance

  6. Volume of distribution at steady state (Vss) [ Time Frame: Through treatment discontinuation: an average of 6 months ]
    volume of distribution at steady state

  7. Anti-Drug Antibodies (ADA) [ Time Frame: Through study completion, an average of 7 months ]
    Anti-Drug Antibodies

  8. Pharmacodynamics (PD) [ Time Frame: Up to 8 weeks ]
    Exploratory biomarker analysis of EGFR and cMet levels in tumor samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 refractory to standard therapy or for which no standard therapy is available or accessible Phase II: Patients with EGFR mutant NSCLC progressed after treatment with EGFR Tyrosine kinase inhibitor(s) [TKI(s)] or patients with EGFR mutation but are intolerant to EGFR TKI(s) treatment.

  • Have adequate organ function.
  • Prior anti-tumor therapy:

    1. Must have stopped any anticancer drug treatment at least 4 weeks or within 5 half -lives .
    2. Generalized radiation therapy must have stopped 3 weeks except for local radiotherapy or radiation therapy for bone metastases which must have stopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticals are taken within 8 weeks before study treatment.
  • Eastern Cooperative Oncology Group (ECOG) score 0 or 1 for phase I, and ≤2 for phase II.

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 the 28-days.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797391


Contacts
Contact: YINGXI ZHANG, MD +86-21-61043299 CT.info@epimab.com

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Ulka Vaishampayan, MD         
United States, Ohio
Gabrail Cancer Center Research Recruiting
Canton, Ohio, United States, 44718
Contact: Nashat Y. Gabrail, MD         
China, Guang Dong
Guangdong General Hospital Not yet recruiting
Guangzhou, Guang Dong, China, 510080
Contact: Yilong Wu, MD         
Sponsors and Collaborators
Shanghai EpimAb Biotherapeutics Co., Ltd.
Covance
Investigators
Principal Investigator: Nashat Y. Gabrail, MD Gabrail Cancer Center Research

Responsible Party: Shanghai EpimAb Biotherapeutics Co., Ltd.
ClinicalTrials.gov Identifier: NCT03797391     History of Changes
Other Study ID Numbers: EMB01X101
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shanghai EpimAb Biotherapeutics Co., Ltd.:
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

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes