Clinical Trials /

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

NCT03797391

Description:

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

Related Conditions:
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Dose Escalation Study of EMB-01 in Participants With Advanced/Metastatic Solid Tumors
  • Official Title: First-in-human, Phase I/II, Multicenter, Open-Label Study of EMB-01 in Patients With Advanced/Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: EMB01X101
  • NCT ID: NCT03797391

Conditions

  • Lung Cancer TNM Staging Distant Metastasis (M)

Interventions

DrugSynonymsArms
EMB-01FIT-013aDose Escalation-Part 1, Expansion-Part 2

Purpose

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 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).
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation-Part 1, Expansion-Part 2ExperimentalIn 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).
  • EMB-01

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose (MTD)
Time Frame:cycle 1 (1cycle = 28 days)
Safety Issue:
Description:Maximum tolerated dose

Secondary Outcome Measures

Measure:Maximum Serum Concentration (Cmax)
Time Frame:Through treatment discontinuation: an average of 6 months
Safety Issue:
Description:Maximum Serum Concentration
Measure:Area Under the Plasma Concentration-Time Curve (AUC)
Time Frame:Through treatment discontinuation: an average of 6 months
Safety Issue:
Description:Area Under the Plasma Concentration-Time Curve
Measure:Trough Serum Concentration (Ctrough)
Time Frame:Through treatment discontinuation: an average of 6 months
Safety Issue:
Description:Trough Serum Concentration
Measure:Elimination half-life (t1/2)
Time Frame:Through treatment discontinuation: an average of 6 months
Safety Issue:
Description:Elimination half-life
Measure:Clearance (CL)
Time Frame:Through treatment discontinuation: an average of 6 months
Safety Issue:
Description:Clearance
Measure:Volume of distribution at steady state (Vss)
Time Frame:Through treatment discontinuation: an average of 6 months
Safety Issue:
Description:volume of distribution at steady state
Measure:Anti-Drug Antibodies (ADA)
Time Frame:Through study completion, an average of 7 months
Safety Issue:
Description:Anti-Drug Antibodies
Measure:Pharmacodynamics (PD)
Time Frame:Up to 8 weeks
Safety Issue:
Description:Exploratory biomarker analysis of EGFR and cMet levels in tumor samples

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Shanghai EpimAb Biotherapeutics Co., Ltd.

Trial 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

Last Updated