A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors

Last updated: October 10, 2023
Sponsor: I-Mab Biopharma US Limited
Overall Status: Completed

Phase

2

Condition

Head And Neck Cancer

Ovarian Cancer

Carcinoma

Treatment

TJ004309

Clinical Study ID

NCT05001347
TJ004309STM103
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cohort 1: Patients with histologically confirmed epithelial ovarian cancer, fallopiantube, or primary peritoneal cancer subjects with any high-grade serous component,progressed on or after platinum-containing therapy and not eligible for furtherplatinum containing treatment (platinum-resistant, platinum-refractory disease definedby progression of disease on a platinum-containing regimen or recurrence of diseasewithin 180 days of receiving the last dose of platinum-based treatment).
  • Cohort 2: Patients with selected tumor types that have relapsed or progressed after 2lines of therapy or who are ineligible for other standard of care (SOC) therapies:
  1. Histologically or cytologically confirmed metastatic NSCLC
  2. Histologically or cytologically confirmed recurrent or metastatic HNSCC (oralcavity, oropharynx, hypopharynx, or larynx)
  3. Histologically or cytologically confirmed metastatic or non-resectable advancedmetastatic gastric or gastroesophageal adenocarcinoma
  4. Histologically or cytologically confirmed unresectable, locally advanced ormetastatic TNBC (confirmed HER2-negative, estrogen receptor-negative andprogesterone receptor-negative)
  5. Histologically confirmed ovarian cancer of all high-grade epithelial types whoare IO treatment naïve and have progressed after 3 months on or afterplatinum-containing therapy
  6. PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% for NSCLC and CombinedProportion Score (CPS) ≥ 1% for all other tumor types
  7. A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1therapy
  8. Patients should have no more than 5 prior lines of therapies
  • Cohort 2 - (Optional for the ovarian cohort) Pre-treatment fresh tumor biopsies andpaired treatment fresh tumor biopsies will be collected from at least 5 patients.Biopsy must be excisional, incisional, or core.

Exclusion

Exclusion Criteria:

  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or withan agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40 [Tumor necrosis factorreceptor superfamily, member 4 (TNFRSF4)], CD137 [tumor necrosis factor receptorsuperfamily member 9 (TNFRSF9)]) (only applies to ovarian cancer patients in Cohorts 1and 2)
  • Disease progression within 6 months of starting anti-PD-1 and anti-PD-L1 inhibitors
  • Known active or chronic Hepatitis B or Hepatitis C, other hepatitides (non-alcoholsteatohepatitis, alcohol or drug-related, autoimmune) serology at screening orcirrhosis
  • Active autoimmune disease requiring systemic treatment within the past 12 months
  • Active interstitial lung disease (ILD) or pneumonitis or a history of ILD
  • Brain involvement with cancer, spinal cord compression, carcinomatous meningitis, ornew evidence of brain or leptomeningeal disease; unless the lesion(s) have beenradiated or resected, are considered fully treated and inactive, are asymptomatic, andno steroids have been administered for CNS disease over the 7 days prior to studytreatment
  • Angina, myocardial infarction (MI), symptomatic congestive heart failure,cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonaryembolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary arterybypass grafting (CABG) within 6 months prior to study treatment
  • Known human immunodeficiency virus (HIV) unless CD4+ T cell count > 350 cells/μL withan undetectable viral load

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: TJ004309
Phase: 2
Study Start date:
November 02, 2021
Estimated Completion Date:
February 08, 2023

Study Description

This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors. This clinical study includes two cohorts: Cohort 1 will include Immuno-Oncology (IO) treatment naïve ovarian cancer (OC) patients who have progressed on or after platinum therapy; and Cohort 2 will include patients with head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), gastrointestinal cancer (GC), triple negative breast cancer (TNBC), or ovarian carcinoma (OC) with PD-L1 expression ≥ 1%. Additional cohorts for selected tumor types might be added later.

Connect with a study center

  • Arizona Oncology Associates

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Innovative Clinical Research Institute

    Whittier, California 90603
    United States

    Site Not Available

  • Medical Oncology Hematology Consultants, PA

    Newark, Delaware 19713
    United States

    Site Not Available

  • Illinois Cancer Specialists

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Affiliated Oncologists

    Chicago Ridge, Illinois 60415
    United States

    Site Not Available

  • Women's Cancer Care

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Maryland Oncology Hematology

    Rockville, Maryland 20850
    United States

    Site Not Available

  • New York Oncology Hematology

    Albany, New York 12206
    United States

    Site Not Available

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York 10016
    United States

    Site Not Available

  • Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Tri County Hematology and Oncology Associates

    Massillon, Ohio 44646
    United States

    Site Not Available

  • Texas Oncology - Arlington North

    Arlington, Texas 76012
    United States

    Site Not Available

  • Texas Oncology - Austin Central

    Austin, Texas 78731
    United States

    Site Not Available

  • Texas Oncology - Bedford

    Bedford, Texas 76022
    United States

    Site Not Available

  • Texas Oncology - Forth Worth Cancer Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Texas Oncology - The Woodlands, Gynecologic Oncology

    The Woodlands, Texas 77380
    United States

    Site Not Available

  • Texas Oncology - Longview Cancer Center

    Tyler, Texas 75601
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Northwest Cancer Specialists

    Vancouver, Washington 98684
    United States

    Site Not Available

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