A Study of EMB-02 in Participants With Advanced Solid Tumors

Last updated: May 17, 2024
Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
Overall Status: Terminated

Phase

1/2

Condition

Neoplasms

Treatment

EMB-02

Clinical Study ID

NCT04618393
EMB02X101
  • Ages > 18
  • All Genders

Study Summary

The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing and able to provide written informed consent.

  • Phase I: Patients with histologically or cytologically confirmed locallyadvanced/metastatic solid tumors and have failed (progressed on, or are intolerantof) standard therapies. Moreover, the disease should be measurable or evaluable perRECIST v1.1

  • Phase II Cohort A: Patients with histologically or cytologically confirmed locallyadvanced/metastatic melanoma, excluding uveal melanoma. > 1 prior therapy, includingprior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And thedisease is measurable or evaluable per RECIST v1.1

  • Archival tumor samples available for retrospective analysis or biopsy will be taken.

  • ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy > 3Months

  • Adequate organ function to participate in the trial.

  • Recovery from adverse events (AEs) related to prior anticancer therapy.

  • Highly effective contraception

Exclusion

Exclusion Criteria:

  • Patients who have active autoimmune disease or history of autoimmune disease

  • History of severe irAE.

  • History of severe allergic reactions

  • Use of systemic corticosteroids.

  • Symptomatic central nervous system metastases.

  • Patients with cardiac dysfunction

  • Uncontrolled diabetes mellitus with hemoglobin A1c > 8% (via medical history)

  • Prior treatment with a LAG-3 inhibitor

  • Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter)prior to study treatment;

  • Prior organ or stem cell/bone marrow transplant.

  • Concurrent malignancy < 5 years prior to entry.

  • Patients with active infections.

  • Major surgery < 4 weeks or minor surgery < 2 weeks prior to study treatment

  • Live virus vaccines < 30 days prior to screening

  • Pregnant or breast-feeding females

  • Any investigational agents or study drugs from a previous clinical study within 30days of the first dose of study treatment

  • Any other serious underlying medical conditions

  • Abuse on alcohol, cannabis- derived products or other drugs

Study Design

Total Participants: 47
Treatment Group(s): 1
Primary Treatment: EMB-02
Phase: 1/2
Study Start date:
March 11, 2021
Estimated Completion Date:
March 21, 2024

Study Description

This is a Phase I/II, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dos(s)e (RP2D[s]) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Connect with a study center

  • Southern Medical Day Care Centre

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Peninsula & South Eastern Haematology & Oncology Group (PASO)

    Frankston, Victoria 3199
    Australia

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • The first Affiliated Hospital of Xiamen University

    Xiamen, Fujian
    China

    Site Not Available

  • HanDan Central Hospital

    Handan, Hebei
    China

    Site Not Available

  • HeNan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • SuiNing Central Hospital

    Suining, Sichuan
    China

    Site Not Available

  • University of Colorado Health Medical Group

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • Prisma Health-Upstate

    Greenville, South Carolina 29605
    United States

    Site Not Available

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