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TerminatedPhase 1NCT05462873
Official study title

A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors

Study summary

To characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of QEQ278 in adult patients with advanced/metastatic non-small cell lung cancer, esophageal squamous cell carcinoma, renal cell carcinoma, and human papilloma virus associated head and neck squamous cell carcinoma.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedQEQ278

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 Feb 17, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Novartis Pharmaceuticals
Interventions being studied
Biological: QEQ278
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
03
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
  • 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.
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California LALos Angeles, California
  • Florida Cancer SpecialistsFort Myers, Florida
  • Massachusetts General Hospital Dept. of Mass General HospitalBoston, Massachusetts
  • Massachusetts General HospitalBoston, Massachusetts
  • Novartis Investigative SiteBrussels
  • Novartis Investigative SiteParis
  • Novartis Investigative SiteEssen
  • Novartis Investigative SiteMilan, MI
  • Novartis Investigative SiteKashiwa, Chiba
  • Novartis Investigative SiteSingapore
  • Novartis Investigative SiteBarcelona
  • Novartis Investigative SiteTaipei

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 17, 2026. Always confirm current availability with the study team.

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