New cancer drug QEQ278 tested in Early-Stage trial
NCT ID NCT05462873
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a new drug, QEQ278, in 30 adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check the drug's safety and find the right dose. The study was stopped early, so results are limited.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Jan 2026
- 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 to 100 years
- 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: * Signed informed consent must be obtained prior to participation in the study. * Adult men and women ≥ 18 years of age. * Histologically confirmed and documented advanced malignancies (locally advanced malignancies, non-curable by surgery or radiotherapy and metastatic disease). Disease must be measurable, including presence of at least one measurable lesion, as determined by RECIST v1.1. * In the opinion of the treating investigator, patients must have received, but are not benefitting from standard therapies, be intolerant or ineligible to receive such therapy, or have no standard therapy option for the respective disease types (diseases listed below), as well as any other therapies deemed to be standard by local/institutional standard. * Non-small cell lung cancer * Esophageal squamous cell carcinoma * Renal cell carcinoma * HPV-associated head and neck squamous cell carcinoma * Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. The patient must be willing to undergo a new tumor biopsy at screening and during treatment. Exclusion Criteria: * Active previously documented or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur should not be excluded. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded. * Patients with a history of or current interstitial lung disease or pneumonitis ≥ Grade 2. * Patients who discontinued prior anti-PD-1 therapy due to an anti-PD-1-related toxicity * Clinically significant cardiac disease or risk factors at screening * Insufficient bone marrow function at screening: * Infections: * Known history of testing positive for Human Immunodeficiency Virus infection. * Active Hepatitis B and / or Hepatitis C. * Active, documented COVID-19 infection * Known history of tuberculosis * Any serious uncontrolled infection (acute or chronic). * Systemic chronic steroid therapy (\>10 mg/day prednisone or equivalent) or any immunosuppressive therapy, other than replacement-dose steroids in the setting of adrenal insufficiency, within 7 days of the first dose of study treatment. Topical, inhaled, and ophthalmic steroids are allowed. Other protocol-defined inclusion/exclusion criteria may apply.
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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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Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Massachusetts General Hospital Dept. of Mass General Hospital
Boston, Massachusetts, 02114, United States
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Novartis Investigative Site
Brussels, 1200, Belgium
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Novartis Investigative Site
Paris, 75231, France
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Novartis Investigative Site
Essen, 45147, Germany
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Novartis Investigative Site
Milan, MI, 20133, Italy
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Novartis Investigative Site
Kashiwa, Chiba, 2778577, Japan
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Novartis Investigative Site
Singapore, 168583, Singapore
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Novartis Investigative Site
Barcelona, 08035, Spain
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Novartis Investigative Site
Taipei, 10002, Taiwan
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University of California LA
Los Angeles, California, 90095, United States
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