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

Last updated: May 30, 2023
Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasm Metastasis

Neoplasms

Treatment

EMB-01

Clinical Study ID

NCT03797391
EMB01X101
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria: Molecular Pre-screening Inclusion criteria (Phase II only)

  1. The patient must sign the molecular pre-screening Inform Consent to allow for themolecular pre-screening process. All patients must have documented evidence of EGFRand/or cMet aberrations. Screening Inclusion Criteria
  2. Able to understand and willing to sign the Informed Consent Form (ICF).
  3. Histologically/cytologically confirmed advanced/metastatic solid tumors withmeasurable 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 orfor which no standard therapy is available or accessible. Phase II: Advanced/metastatic NSCLC Patients have confirmed EGFR mutant and/or cMETaberration, and have progressed after standard treatment (including platinum-basedtherapy) or are intolerant to standard treatment. Additionally, patients with T790Mmutation have received FDA/Health Authority approved therapies (if accessible) forthis indication (i.e., osimertinib) and have progressed or became intolerant. A patient who has refused all currently available therapy is allowed to enroll, butmust be documented in the source record.
  4. Must have adequate organ function.
  5. Regarding prior anti-tumor therapy:
  6. Must have stopped treatment at least 4 weeks or within 5 half-lives.
  7. Generalized radiation therapy must have stopped 3 weeks before first dose of EMB 01, or local radiotherapy or radiation therapy for bone metastases must havestopped 2 weeks before first dose of EMB-01. No therapeutic radiopharmaceuticalsare taken within 8 weeks before first dose of EMB-01.
  8. Patients must have recovered to ≤Grade 1 from the adverse effects of such abovetreatment before beginning study treatment.
  9. Female patient with fertility or male patient whose partner has fertility should useone or more contraceptive methods for contraception starting from screening period andcontinue throughout the study treatment and for 3 months.
  10. ECOG score 0 or 1 for phase I, and ≤2 for phase II.

Exclusion

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:

  1. Patients who are unwilling to sign the molecular pre-screening ICF.
  2. Patients for whom local EGFR and/or cMET data or the results of central laboratorytesting do not meet the molecular pre-screening inclusion criteria. Screening Exclusion Criteria
  3. Life expectancy < 3 months.
  4. Subject with primacy central nervous system (CNS) malignancy or symptomatic CNS (leptomeningeal or brain) metastases.
  5. Pregnant or nursing females.
  6. Subjects who have had major surgery within 28 days prior to screening.
  7. Serious underlying medical conditions, including but not limited to un-controlledhypertension, other cardiovascular disease or diabetes, ongoing or active infection,psychiatric, psychological, familial or geographical condition that, in the judgmentof the investigator, may interfere the compliance with study treatment.

Study Design

Total Participants: 186
Treatment Group(s): 1
Primary Treatment: EMB-01
Phase: 1/2
Study Start date:
December 13, 2018
Estimated Completion Date:
January 15, 2026

Study 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).

Connect with a study center

  • Guangdong General Hospital

    Guangzhou, Guang Dong 510080
    China

    Active - Recruiting

  • Shanghai Chest Hosptial

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Active - Recruiting

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