For Healthcare Professionals

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


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Signed informed consent must be obtained prior to participation in the study.
  2. Adult men and women ≥ 18 years of age.
  3. 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.
  4. 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.
  5. Non-small cell lung cancer
  6. Esophageal squamous cell carcinoma
  7. Renal cell carcinoma
  8. HPV-associated head and neck squamous cell carcinoma
  9. 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:

  1. 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.
  2. Patients with a history of or current interstitial lung disease or pneumonitis ≥ Grade 2.
  3. Patients who discontinued prior anti-PD-1 therapy due to an anti-PD-1-related toxicity
  4. Clinically significant cardiac disease or risk factors at screening
  5. Insufficient bone marrow function at screening:
  6. Infections:
  7. Known history of testing positive for Human Immunodeficiency Virus infection.
  8. Active Hepatitis B and / or Hepatitis C.
  9. Active, documented COVID-19 infection
  10. Known history of tuberculosis
  11. Any serious uncontrolled infection (acute or chronic).
  12. 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.

pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

Study’s details


Carcinoma, Non-Small-Cell Lung,Carcinoma, Renal Cell,Esophageal Squamous Cell Carcinoma,Squamous Cell Carcinoma of Head and Neck

Age (in years)



Phase 1

Participants needed


Est. Completion Date

Sep 24, 2025

Treatment type



Novartis identifier


Study number


Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?


Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.