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
1 other identifier
interventional
25
1 country
15
Brief Summary
This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 ovarian-cancer
Started Nov 2021
Shorter than P25 for phase_2 ovarian-cancer
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedStudy Start
First participant enrolled
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2023
CompletedResults Posted
Study results publicly available
December 16, 2025
CompletedDecember 16, 2025
November 1, 2025
1.3 years
July 12, 2021
September 18, 2025
November 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Up to 66 weeks
Study Arms (1)
TJ004309 and Atezolizumab
EXPERIMENTALTJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Arizona Oncology Associates
Tucson, Arizona, 85711, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
Women's Cancer Care
Covington, Louisiana, 70433, United States
Maryland Oncology Hematology
Rockville, Maryland, 20850, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Duke Cancer Center
Durham, North Carolina, 27710, United States
Tri County Hematology and Oncology Associates
Massillon, Ohio, 44646, United States
Texas Oncology - Arlington North
Arlington, Texas, 76012, United States
Texas Oncology - Austin Central
Austin, Texas, 78731, United States
Texas Oncology - Forth Worth Cancer Center
Fort Worth, Texas, 76104, United States
Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands, Texas, 77380, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Northwest Cancer Specialists
Vancouver, Washington, 98684, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP of Clinical Development
- Organization
- I-Mab Biopharma
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2021
First Posted
August 11, 2021
Study Start
November 2, 2021
Primary Completion
February 8, 2023
Study Completion
February 8, 2023
Last Updated
December 16, 2025
Results First Posted
December 16, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share