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

A Phase 2 Clinical Study of TJ004309 in Combination With Atezolizumab (TECENTRIQ®) in Patients With Advanced or Metastatic Ovarian Cancers and Selected Advanced Solid Tumors

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

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Ovarian Cancer; Non Small Cell Lung Cancer; Triple Negative Breast Cancer; Gastrointestinal Cancer; Ovarian Carcinoma
• Intervention / Treatment: Drug: TJ004309

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates
  • California
    • Whittier, California, United States, 90603
      • Innovative Clinical Research Institute
  • Delaware
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants, PA
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Illinois Cancer Specialists
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Women'S Cancer Care
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Maryland Oncology Hematology
  • New York
    • New York, New York, United States, 10016
      • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center
  • Ohio
    • Massillon, Ohio, United States, 44646
      • Tri County Hematology and Oncology Associates
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Oncology - Arlington North
    • Austin, Texas, United States, 78731
      • Texas Oncology - Austin Central
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - Forth Worth Cancer Center
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - The Woodlands, Gynecologic Oncology
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
  • Washington
    • Vancouver, Washington, United States, 98684
      • Northwest Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. Histologically or cytologically confirmed metastatic NSCLC
  2. Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx)
  3. Histologically or cytologically confirmed metastatic or non-resectable advanced metastatic gastric or gastroesophageal adenocarcinoma
  4. Histologically or cytologically confirmed unresectable, locally advanced or metastatic TNBC (confirmed HER2-negative, estrogen receptor-negative and progesterone receptor-negative)
  5. 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
  6. PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% for NSCLC and Combined Proportion Score (CPS) ≥ 1% for all other tumor types
  7. A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1 therapy
  8. 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TJ004309 and Atezolizumab; TJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W	Drug: TJ004309; Antibody to CD73

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types	Anti-tumor activity of the combination of TJ004309 and atezolizumab was measured by objective response rate (ORR) based on RECIST 1.1	Up to 66 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
o Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types	Anti-tumor activity of the combination of TJ004309 and atezolizumab was measured by objective response rate (ORR) based on iRECIST.	Up to 66 weeks

Collaborators and Investigators

• Sponsor: I-Mab Biopharma US Limited

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: July 12, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Genital Diseases, Female; Lung Diseases; Endocrine Gland Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Breast Neoplasms; Skin and Connective Tissue Diseases; Ovarian Neoplasms; Gastrointestinal Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: TJ004309STM103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No