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A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

A Phase I/Ib, Open-label, Multi-center, Study of QEQ278 in Patients With Advanced Solid Tumors

NCT05462873•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (12)

University of California LA

Los Angeles, California, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Massachusetts General Hospital Dept. of Mass General Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Singapore, Singapore

Key Dates

Start Date

April 4, 2023

Primary Completion Date

January 26, 2026

Completion Date

January 26, 2026

Last Updated

February 17, 2026

Enrollment

ACTUAL participants

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, Renal CellEsophageal Squamous Cell CarcinomaSquamous Cell Carcinoma of Head and Neck

Interventions

QEQ278

BIOLOGICAL

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

NCT07403136

Esophageal Squamous Cell Carcinoma

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RECRUITINGPHASE2

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

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RECRUITING

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

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