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

Last updated: April 7, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

1

Condition

Carcinoma

Esophageal Disorders

Squamous Cell Carcinoma

Treatment

QEQ278

Clinical Study ID

NCT05462873
CQEQ278A12101
  • Ages 18-100
  • All Genders

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.

Eligibility Criteria

Inclusion

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 advancedmalignancies, non-curable by surgery or radiotherapy and metastatic disease).Disease must be measurable, including presence of at least one measurable lesion, asdetermined by RECIST v1.1.

  • In the opinion of the treating investigator, patients must have received, but arenot benefitting from standard therapies, be intolerant or ineligible to receive suchtherapy, or have no standard therapy option for the respective disease types (diseases listed below), as well as any other therapies deemed to be standard bylocal/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 biopsyaccording to the treating institution's guidelines. The patient must be willing toundergo a new tumor biopsy at screening and during treatment.

Exclusion

Exclusion Criteria:

  • Active previously documented or suspected autoimmune disease. Patients withvitiligo, type I diabetes, residual hypothyroidism only requiring hormonereplacement, psoriasis not requiring systemic treatment, or conditions not expectedto recur should not be excluded. Patients previously exposed to anti-PD-1/PD-L1treatment who are adequately treated for skin rash or with replacement therapy forendocrinopathies 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-relatedtoxicity

  • 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 anyimmunosuppressive therapy, other than replacement-dose steroids in the setting ofadrenal 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 Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: QEQ278
Phase: 1
Study Start date:
April 04, 2023
Estimated Completion Date:
September 16, 2025

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Paris, 75231
    France

    Site Not Available

  • Novartis Investigative Site

    Essen, 45147
    Germany

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20133
    Italy

    Site Not Available

  • Novartis Investigative Site

    Kashiwa, Chiba 277 8577
    Japan

    Site Not Available

  • Novartis Investigative Site

    Singapore, 168583
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08035
    Spain

    Site Not Available

  • Novartis Investigative Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • UCLA Medical Center Santa Monica Location

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University Of California Los Angeles Santa Monica Location

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of California LA

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California LA Santa Monica Location

    Los Angeles, California 90095
    United States

    Site Not Available

  • Florida Cancer Specialists

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Florida Cancer Specialists Sarasota Office

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Massachusetts General Hospital Dept. of Mass General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.