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.
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.