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

Completed · Phase 2

Conditions studied: Ovarian Cancer, Head and Neck Cancer, Non Small Cell Lung Cancer, Gastrointestinal Cancer, Triple Negative Breast Cancer, Ovarian Carcinoma

In brief

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

Key facts

Study ID

NCT05001347

Run by

I-Mab Biopharma US Limited

People needed

25

Starts

2021-11-02

Expected to finish

2023-02-08

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an 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 factor receptor superfamily, member 4 (TNFRSF4)], CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) (only applies to ovarian cancer patients in Cohorts 1 and 2)
• Disease progression within 3 months of starting anti-PD-1 and anti-PD-L1 inhibitors
• Known active or chronic Hepatitis B or Hepatitis C, other hepatitides (non-alcohol steatohepatitis, alcohol or drug-related, autoimmune) serology at screening or cirrhosis
• 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, or new evidence of brain or leptomeningeal disease; unless the lesion(s) have been radiated or resected, are considered fully treated and inactive, are asymptomatic, and no steroids have been administered for CNS disease over the 7 days prior to study treatment
• Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
• Known human immunodeficiency virus (HIV) unless CD4+ T cell count > 350 cells/μL with an undetectable viral load

Where it is running

• Arizona Oncology Associates — Tucson, Arizona, United States
• Innovative Clinical Research Institute — Whittier, California, United States
• Medical Oncology Hematology Consultants, PA — Newark, Delaware, United States
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States
• Women's Cancer Care — Covington, Louisiana, United States
• Maryland Oncology Hematology — Rockville, Maryland, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
• Duke Cancer Center — Durham, North Carolina, United States
• Tri County Hematology and Oncology Associates — Massillon, Ohio, United States
• Texas Oncology - Arlington North — Arlington, Texas, United States
• Texas Oncology - Austin Central — Austin, Texas, United States
• Texas Oncology - Forth Worth Cancer Center — Fort Worth, Texas, United States
• Texas Oncology - The Woodlands, Gynecologic Oncology — The Woodlands, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Northwest Cancer Specialists — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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