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

NCT05462873 | Terminated Phase 1 FDA Drug

• 1 other identifier: CQEQ278A12101
• Study Type: interventional
• Target: 30
• Locations: 9 countries
• Sites: 12

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.

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Esophageal Squamous Cell Carcinoma; Squamous Cell Carcinoma of Head and Neck

Keywords

NKG2D; NKG2D-L; immunotherapy; ADCC; NK cells; NSCLC; ESCC; RCC; HPV-associated HNSCC; QEQ278

Outcome Measures

Primary Outcomes (4)

• Incidence and nature of Dose Limiting Toxicities (DLTs) during the DLT evaluation period for single agent QEQ278

  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.

  28 days

• Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

  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.

  Up to 31 months

• Frequency of dose interruptions, reductions

  Number of dose interruptions of QEQ278 and number of dose reductions of QEQ278

  Up to 30 months

• Dose intensity

  Dose intensity of QEQ278 is defined as the ratio of actual cumulative dose received and actual duration of exposure.

  Up to 30 months

Secondary Outcomes (12)

• Overall response rate (ORR) per RECIST v1.1

  Up to 30 months

• Disease control rate (DCR) per RECIST v1.1

  Up to 30 months

• Duration of Response (DOR) per RECIST v1.1

  Up to 30 months

• Progression-free survival (PFS) per RECIST v 1.1

  Up to 30 months

• Peak serum concentration (Cmax) of QEQ278

  During first 168 days of treatment

Study Arms (2)

Part 1: Dose escalation

EXPERIMENTAL

Dose escalation with QEQ278 single agent

Biological: QEQ278

Part 2: Dose expansion

EXPERIMENTAL

Dose expansion with QEQ278 single agent

Biological: QEQ278

Interventions

QEQ278 BIOLOGICAL

Intravenous dosing of QEQ278

Part 1: Dose escalation; Part 2: Dose expansion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (12)

University of California LA

Los Angeles, California, 90095, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Massachusetts General Hospital Dept. of Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Paris, 75231, France

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Kashiwa, Chiba, 2778577, Japan

Location

Novartis Investigative Site

Singapore, 168583, Singapore

Location

Novartis Investigative Site

Barcelona, 08035, Spain

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Esophageal Squamous Cell Carcinoma; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: April 4, 2023
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); DE (1); ES (1); FR (1); TW (1); US (4); JP (1); SG (1); BE (1)