First in Human Study of EMB-07 in Locally Advanced/Metastatic Solid Tumors or Relapse/Refractory Lymphoma

Last updated: February 28, 2025
Sponsor: EpimAb Biotherapeutics (Suzhou)Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Neoplasms

Treatment

EMB07

Clinical Study ID

NCT05607498
EMB07X101
  • Ages > 18
  • All Genders

Study Summary

For solid tumors and lymphoma, respectively: This study is to evaluate the safety and tolerability of EMB-07 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-07 will also be assessed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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.

  2. Male or female, and aged ≥ 18 years

  3. Treatment group A: Patients with histologically or cytologically locally advancedunresectable or metastatic solid tumors limiting to triple-negative breast cancer,lung adenocarcinoma, ovarian cancer, pancreatic cancer, colorectal cancer, gastriccancer, prostate cancer, bladder cancer, and uterus cancer. Treatment group B:Patients with histologically or cytologically relapse/refractory lymphoma limitingto chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle celllymphoma (MCL) and diffuse large B cell lymphoma (DLBCL).

  4. Treatment group A: Standard therapies do not exist, or are no longer effective, orare not tolerable or accessible to the patient measurable or evaluable disease perRECIST V1.1. Treatment group B: Presence of at least one two-dimensional measurablelesion confirmed by imaging (CT or MRI) (either lymph nodes lesions with any longdiameter > 1.5 cm or extranodal lesions with any long diameter > 1.0 cm); for CLLpatients whose baseline imaging evaluation determined that no two-dimensionalmeasurable lesions, their peripheral blood monoclonal B lymphocytes should be ≥ 5.0×109/L.

  5. Patients must provide archival tumor samples, or a biopsy will be required ifarchival tumor sample is not available. Archival tumor sample must be taken ≤ 2years prior to screening, otherwise a fresh tumor biopsy at screening is required.

  6. ECOG performance status 0 or 1

  7. Adequate organ function to participate in the trial.

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

Exclusion

Exclusion Criteria:

  1. Prior treatment with any agent targeting ROR1.

  2. History of Grade 4 immune-related adverse events (irAEs) or irAEs requiringdiscontinuation of prior therapies.

  3. Patient with primary central nervous system (CNS) malignancy or symptomatic CNSmetastases. Patients with solid tumors with CNS metastases are eligible if they donot need to receive local radiation treatment at the discretion of investigator orif radiation therapy for CNS metastases is completed ≥ 4 weeks prior to studytreatment.

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

  5. Abuse on alcohol, cannabis-derived products, or other drugs.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: EMB07
Phase: 1
Study Start date:
March 01, 2023
Estimated Completion Date:
March 31, 2026

Study Description

This is a phase I, multicenter, open label, dose escalation, 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-07 in patient with locally advanced/metastatic solid tumors or relapse/refractory Lymphoma . Pharmacokinetics, pharmacodynamics, immunogenicity and response will also be assessed.

Connect with a study center

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria
    Australia

    Active - Recruiting

  • One Clinical Research

    Nedlands, Western Australia
    Australia

    Active - Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • Affiliated Hospital of Hebei University

    Baoding,
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu,
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou,
    China

    Active - Recruiting

  • The Affiliated Tumour Hospital of Harbin Medical University

    Harbin,
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Shandong,
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institue & Hospital

    Tianjin,
    China

    Active - Recruiting

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