Lung Cancer Clinical Trial

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

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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Full 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.

View Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

125

Study ID:

NCT05462873

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 11 Locations for this study

See Locations Near You

University Of California LA Santa Monica Location
Los Angeles California, 90095, United States More Info
Lisa Zhou
Contact
310-582-4069
[email protected]
Zev A Wainberg
Principal Investigator
Florida Cancer Specialists Sarasota Office
Fort Myers Florida, 33901, United States More Info
Erin Finch
Contact
941-377-9993
[email protected]
Manish Patel
Principal Investigator
Massachusetts General Hospital Dept. of Mass General Hospital
Boston Massachusetts, 02114, United States More Info
Justin Gainor
Contact
617-724-4000
[email protected]
Justin Gainor
Principal Investigator
Novartis Investigative Site
Bruxelles , 1200, Belgium
Novartis Investigative Site
Paris , 75231, France
Novartis Investigative Site
Essen , 45147, Germany
Novartis Investigative Site
Milano MI, 20133, Italy
Novartis Investigative Site
Kashiwa Chiba, 277 8, Japan
Novartis Investigative Site
Singapore , 16858, Singapore
Novartis Investigative Site
Barcelona Catalunya, 08035, Spain
Novartis Investigative Site
Taipei , 10002, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

125

Study ID:

NCT05462873

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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