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

ClinicalTrials.gov Identifier: NCT05462873

Novartis Reference Number: CQEQ278A12101

Last Update: Jan 26, 2023

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

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.

Condition 
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Esophageal Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Phase 
Phase 1
Overall status 
Recruiting
Start date 
Jan 31, 2023
Completion date 
May 27, 2025
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
QEQ278
Intravenous dosing of 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 Locations

United States
Massachusetts General Hospital Dept. of Mass General Hospital
Recruiting
Boston, 02114 - Massachusetts
Contact: Justin Gainor (617-724-4000) - [email protected] - Justin Gainor
United States
Taiwan
Novartis Investigative Site
Recruiting
Taipei, 10002
-
Taiwan

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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