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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    43
  • sponsor
    Shanghai EpimAb Biotherapeutics Co., Ltd.
Updated on 24 April 2022

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.

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 dose (RP2D) for EMB-02 in patients with advanced solid tumors. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Details
Condition Advanced Solid Tumors
Treatment EMB-02
Clinical Study IdentifierNCT04618393
SponsorShanghai EpimAb Biotherapeutics Co., Ltd.
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing and able to provide written informed consent
Phase I: Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. Moreover, the disease should be measurable or evaluable per RECIST v1.1
Phase II Cohort A: Patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. > 1 prior therapy, including prior treatment with PD-1/L1(mandatory) and/or CTLA-4 inhibitors(optional). And the disease 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 > 3 Months
Adequate organ function to participate in the trial
Recovery from adverse events (AEs) related to prior anticancer therapy
Highly effective contraception

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 30 days of the first dose of study treatment
Any other serious underlying medical conditions
Abuse on alcohol, cannabis- derived products or other drugs
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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