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Trial record 1 of 1 for:    05462873 | Recruiting, Not yet recruiting Studies | Spain
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A Study to Investigate the Safety and Tolerability of Intravenous QEQ278 in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT05462873
Recruitment Status : Recruiting
First Posted : July 18, 2022
Last Update Posted : April 15, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Esophageal Squamous Cell Carcinoma Squamous Cell Carcinoma of Head and Neck Biological: QEQ278 Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/Ib, Open-label, Multi-center, Study of QEQ278 in Patients With Advanced Solid Tumors
Actual Study Start Date : April 4, 2023
Estimated Primary Completion Date : January 9, 2026
Estimated Study Completion Date : January 9, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose escalation
Dose escalation with QEQ278 single agent
 Biological: QEQ278
Intravenous dosing of QEQ278
Experimental: Part 2: Dose expansion
Dose expansion with QEQ278 single agent
 Biological: QEQ278
Intravenous dosing of QEQ278


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and nature of Dose Limiting Toxicities (DLTs) during the DLT evaluation period for single agent QEQ278 [ Time Frame: 28 days ]
    A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT evaluation period and meets the criteria defined in the study protocol.

  2. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 31 months ]
    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in laboratory values, vital signs, and electrocardiograms (ECGs) qualifying and reported as AEs.

  3. Frequency of dose interruptions, reductions [ Time Frame: Up to 30 months ]
    Number of dose interruptions of QEQ278 and number of dose reductions of QEQ278

  4. Dose intensity [ Time Frame: Up to 30 months ]
    Dose intensity of QEQ278 is defined as the ratio of actual cumulative dose received and actual duration of exposure.


Secondary Outcome Measures :
  1. Overall response rate (ORR) per RECIST v1.1 [ Time Frame: Up to 30 months ]
    ORR is defined as the proportion of patients with a confirmed BOR of complete response (CR) or partial response (PR) by local investigator review as per RECIST v1.1.

  2. Disease control rate (DCR) per RECIST v1.1 [ Time Frame: Up to 30 months ]
    DCR is defined as the proportion of patients with a confirmed best overall response (BOR) of CR or PR or stable disease (SD) by local investigator review as per RECIST v1.1.

  3. Duration of Response (DOR) per RECIST v1.1 [ Time Frame: Up to 30 months ]
    DOR is defined as the time form the date of the first documented response (CR or PR) to the date of the first documented progression by local investigator review as per RECIST v1.1 or death due to underlying cancer.

  4. Progression-free survival (PFS) per RECIST v 1.1 [ Time Frame: Up to 30 months ]
    PFS is defined as the time from the date of start of treatment to the date of the first documented progression by local investigator review as per RECIST v1.1, or death due to any cause.

  5. Peak serum concentration (Cmax) of QEQ278 [ Time Frame: During first 168 days of treatment ]
    The maximum (peak) serum drug concentration after single dose administration

  6. Area under the concentration time curve (AUC) last of QEQ278 [ Time Frame: During first 168 days of treatment ]
    The AUC from time zero to the last measurable concentration sampling time

  7. Area under the concentration time curve (AUC) infinity of QEQ278 [ Time Frame: During first 168 days of treatment ]
    The AUC from time zero to infinity

  8. Time to reach peak serum concentration (Tmax) of QEQ278 [ Time Frame: During first 168 days of treatment ]
    The time to reach maximum (peak) serum drug concentration after single dose administration

  9. Elimination half-life (T1/2) of QEQ278 [ Time Frame: During first 168 days of treatment ]
    The elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve

  10. Total body clearance (CL) of QEQ278 [ Time Frame: During first 168 days of treatment ]
    The total body clearance of drug from the serum

  11. Volume of distribution (Vz) of QEQ278 [ Time Frame: During first 168 days of treatment ]
    The apparent volume of distribution during terminal phase

  12. Incidence of anti-drug antibody (ADA) [ Time Frame: Day 1 and 15 ]
    Immunogenicity of QEQ278


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05462873


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
University Of California LA Santa Monica Location Recruiting
Los Angeles, California, United States, 90095
Contact: Lisa Zhou    310-582-4069    LisaZhou@mednet.ucla.edu   
Principal Investigator: Zev A Wainberg         
United States, Florida
Florida Cancer Specialists Sarasota Office Recruiting
Fort Myers, Florida, United States, 33901
Contact: Erin Finch    941-377-9993    erin.finch@flcancer.com   
Principal Investigator: Manish Patel         
United States, Massachusetts
Massachusetts General Hospital Dept. of Mass General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Justin Gainor    617-724-4000    jgainor@partners.org   
Principal Investigator: Justin Gainor         
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1200
France
Novartis Investigative Site Recruiting
Paris, France, 75231
Germany
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Italy
Novartis Investigative Site Recruiting
Milano, MI, Italy, 20133
Japan
Novartis Investigative Site Recruiting
Kashiwa, Chiba, Japan, 277 8577
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 168583
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Taiwan
Novartis Investigative Site Recruiting
Taipei, Taiwan, 10002
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05462873    
Other Study ID Numbers: CQEQ278A12101
First Posted: July 18, 2022    Key Record Dates
Last Update Posted: April 15, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
NKG2D
NKG2D-L
immunotherapy
ADCC
NK cells
 NSCLC
ESCC
RCC
HPV-associated HNSCC
QEQ278
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
 Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases