CompletedPhase 2NCT05001347
Official study titleA Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors
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.
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Key things to know
Main goalTreatment
This describes the study’s primary purpose.
What is being studiedTJ004309
The study team can explain what participation involves.
Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 16, 2025 · Source: ClinicalTrials.gov
Is enrollment open?Completed
Ask the study team to confirm whether enrollment is open.
What kind of study?Phase 2
Interventional
Where is it offered?15 U.S. locations
Locations may change over time.
Who runs it?I-Mab Biopharma US Limited
Study sponsor
Study overview
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- I-Mab Biopharma US Limited
- Interventions being studied
- Drug: TJ004309
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How this study is categorized
These labels come from structured fields and exact terms in the public record.
Cancer type
Disease setting
Treatment approach
Public criteria
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
Study sites
U.S. locations
- Arizona Oncology AssociatesTucson, Arizona
- Innovative Clinical Research InstituteWhittier, California
- Medical Oncology Hematology Consultants, PANewark, Delaware
- Illinois Cancer SpecialistsArlington Heights, Illinois
- Women's Cancer CareCovington, Louisiana
- Maryland Oncology HematologyRockville, Maryland
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, New York
- Duke Cancer CenterDurham, North Carolina
- Tri County Hematology and Oncology AssociatesMassillon, Ohio
- Texas Oncology - Arlington NorthArlington, Texas
- Texas Oncology - Austin CentralAustin, Texas
- Texas Oncology - Forth Worth Cancer CenterFort Worth, Texas
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 16, 2025. Always confirm current availability with the study team.