For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Willing and able to provide written informed consent.
  2. 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
  3. 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
  4. Archival tumor samples available for retrospective analysis or biopsy will be taken.
  5. ECOG performance status 0 or 1 for phase I, and ≤2 for phase II; life expectancy > 3 Months
  6. Adequate organ function to participate in the trial.
  7. Recovery from adverse events (AEs) related to prior anticancer therapy.
  8. Highly effective contraception

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Patients who have active autoimmune disease or history of autoimmune disease
  2. History of severe irAE.
  3. History of severe allergic reactions
  4. Use of systemic corticosteroids.
  5. Symptomatic central nervous system metastases.
  6. Patients with cardiac dysfunction
  7. Uncontrolled diabetes mellitus with hemoglobin A1c > 8% (via medical history)
  8. Prior treatment with a LAG-3 inhibitor
  9. Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment;
  10. Prior organ or stem cell/bone marrow transplant.
  11. Concurrent malignancy < 5 years prior to entry.
  12. Patients with active infections.
  13. Major surgery < 4 weeks or minor surgery < 2 weeks prior to study treatment
  14. Live virus vaccines < 30 days prior to screening
  15. Pregnant or breast-feeding females
  16. Any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment
  17. Any other serious underlying medical conditions
  18. Abuse on alcohol, cannabis- derived products or other drugs
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +8618621781427Email iconEmail Study Center

Study’s details


Contition

Advanced Solid Tumors

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

43

Est. Completion Date

Dec 31, 2025

Treatment type

Interventional


Sponsor

Shanghai EpimAb Biotherapeutics Co., Ltd.

ClinicalTrials.gov identifier

NCT04618393

Study number

EMB02X101

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