A Study of EMB-09 in Participants With Advanced or Metastatic Solid Tumors.

Last updated: October 16, 2023
Sponsor: Shanghai EpimAb Biotherapeutics Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

EMB-09

Clinical Study ID

NCT05263180
EMB09X101
  • Ages > 18
  • All Genders

Study Summary

This study is to evaluate the safety and tolerability of EMB-09 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Pharmacokinetics (PK), immunogenicity, and the anti-multiple myeloma activity of EMB-09 will also be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Willing and able to provide signed and dated informed consent prior to anystudy-related procedures and willing and able to comply with all study procedures.
  • Phase I subjects:
  1. Patients with histologically or cytologically confirmed locallyadvanced/metastatic solid tumors including but not limited to melanoma, non-smallcell lung cancer (NSCLC), triple negative breast cancer (TNBC), head and necksquamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), hepatocellularcarcinoma (HCC), gastric cancer (GC), endometrium cancer (EC), ovarian cancer (OC), renal cell carcinoma (RCC) and small cell lung cancer (SCLC), colorectalcancer (CRC).
  2. Patients who have failed (progressed on, or are intolerant of) standard therapiesor no available standard treatment
  3. Measurable or evaluable disease per RECIST v1.1.
  • Patients must provide archival tumor, or a fresh tumor biopsy will be required ifarchival tumor sample is not available. Archival tumor sample must be taken <2 yearsprior to screening, otherwise a fresh tumor biopsy at screening is required.
  • ECOG performance status 0 or 1; 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

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 TNFRSF agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR), CD40.
  • Anticancer therapy or radiation < 5 half-lives or 4 weeks (whichever is shorter) priorto study treatment;
  • Current or history of idiopathic pulmonary fibrosis, interstitial lung disease, ororganizing pneumonia.
  • 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 of alcohol, cannabis-derived products, or other drugs.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: EMB-09
Phase: 1
Study Start date:
July 25, 2022
Estimated Completion Date:
December 31, 2024

Study Description

This is a phase I, 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 for EMB-09 in patient with advanced or metastatic solid tumors. Pharmacokinetics,pharmacodynamics, immunogenicity and response will also be assessed.

Connect with a study center

  • Peninsula and South Eastern Haematology & Oncology Group

    Frankston,
    Australia

    Active - Recruiting

  • GenesisCareNorthShore

    Leonards Hill,
    Australia

    Active - Recruiting

  • Blacktown Hospital

    Sydney,
    Australia

    Active - Recruiting

  • FUSCC

    Shanghai,
    China

    Active - Recruiting

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