Study Description
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.
This study is an open-label, phase I/Ib, multi-center study of QEQ278 as a single agent, consisting of a dose escalation part followed by a dose expansion part.
In the dose escalation part of the study, patients with non-small cell lung cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), renal cell carcinoma (RCC), or human papilloma virus (HPV)-associated head and neck squamous cell carcinoma (HNSCC) will be treated with QEQ278 single agent until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established.
The study may enter the dose expansion, after an MTD(s) and/or RD(s) is declared in the dose escalation.
Interventions
QEQ278
Eligibility Criteria
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.
Study Location
Novartis Investigative Site
Recruiting
Bruxelles,1200,Belgium
Novartis Investigative Site
Recruiting
Paris,75231,France
Novartis Investigative Site
Recruiting
Essen,45147,Germany
Novartis Investigative Site
Recruiting
Milano,MI,20133,Italy
Novartis Investigative Site
Recruiting
Kashiwa,Chiba,277 8577,Japan
Novartis Investigative Site
Recruiting
Singapore,168583,Singapore
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
Recruiting
Taipei,10002,Taiwan
University Of California LA Santa Monica Location
Recruiting
Los Angeles,Lisa Zhou (310-582-4069) email: [email protected] -- Zev A Wainberg,90095 - California,United States
Florida Cancer Specialists Sarasota Office
Recruiting
Fort Myers,Erin Finch (941-377-9993) email: [email protected] -- Manish Patel,33901 - Florida,United States
Massachusetts General Hospital Dept. of Mass General Hospital
Recruiting
Boston,Justin Gainor (617-724-4000) email: [email protected] -- Justin Gainor,02114 - Massachusetts,United States
Worldwide Contacts
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