Experimental combo shows promise in Hard-to-Treat cancers
NCT ID NCT05001347
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug (TJ004309) combined with an approved immunotherapy (atezolizumab) in 25 people with advanced ovarian, head and neck, lung, gastrointestinal, or triple-negative breast cancers. The goal was to see if the combination could shrink tumors. Participants had cancers that stopped responding to standard treatments. The study is complete, and results help guide future research.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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25 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Feb 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Arizona Oncology Associates
Tucson, Arizona, 85711, United States
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Duke Cancer Center
Durham, North Carolina, 27710, United States
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Illinois Cancer Specialists
Arlington Heights, Illinois, 60005, United States
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Innovative Clinical Research Institute
Whittier, California, 90603, United States
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Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
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Maryland Oncology Hematology
Rockville, Maryland, 20850, United States
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Medical Oncology Hematology Consultants, PA
Newark, Delaware, 19713, United States
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Northwest Cancer Specialists
Vancouver, Washington, 98684, United States
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Texas Oncology - Arlington North
Arlington, Texas, 76012, United States
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Texas Oncology - Austin Central
Austin, Texas, 78731, United States
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Texas Oncology - Forth Worth Cancer Center
Fort Worth, Texas, 76104, United States
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Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands, Texas, 77380, United States
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Tri County Hematology and Oncology Associates
Massillon, Ohio, 44646, United States
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Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
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Women's Cancer Care
Covington, Louisiana, 70433, United States
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Other studies related to the condition(s) this trial covers.
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- Ovarian Cancer's spread: scientists probe abdominal fluid for clues