A Phase 1 interventional study of QEQ278 in Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell and Esophageal Squamous Cell Carcinoma, sponsored by Novartis Pharmaceuticals. Terminated at 12 sites in 9 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment
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.
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.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 30 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Dose escalation with QEQ278 single agent
Biological: QEQ278
Dose expansion with QEQ278 single agent
Biological: QEQ278
Intravenous dosing of QEQ278
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.
Time frame: 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.
Time frame: Up to 31 months
Frequency of dose interruptions, reductions
Number of dose interruptions of QEQ278 and number of dose reductions of QEQ278
Time frame: 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.
Time frame: Up to 30 months
Overall response rate (ORR) per RECIST v1.1
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.
Time frame: Up to 30 months
Disease control rate (DCR) per RECIST v1.1
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.
Time frame: Up to 30 months
Duration of Response (DOR) per RECIST v1.1
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.
Time frame: Up to 30 months
Progression-free survival (PFS) per RECIST v 1.1
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.
Time frame: Up to 30 months
Peak serum concentration (Cmax) of QEQ278
The maximum (peak) serum drug concentration after single dose administration
Time frame: During first 168 days of treatment
Area under the concentration time curve (AUC) last of QEQ278
The AUC from time zero to the last measurable concentration sampling time
Time frame: During first 168 days of treatment
Area under the concentration time curve (AUC) infinity of QEQ278
The AUC from time zero to infinity
Time frame: During first 168 days of treatment
Time to reach peak serum concentration (Tmax) of QEQ278
The time to reach maximum (peak) serum drug concentration after single dose administration
Time frame: During first 168 days of treatment
Elimination half-life (T1/2) of QEQ278
The elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve
Time frame: During first 168 days of treatment
Total body clearance (CL) of QEQ278
The total body clearance of drug from the serum
Time frame: During first 168 days of treatment
Volume of distribution (Vz) of QEQ278
The apparent volume of distribution during terminal phase
Time frame: During first 168 days of treatment
Incidence of anti-drug antibody (ADA)
Immunogenicity of QEQ278
Time frame: Day 1 and 15
Plan to share: No
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This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Novartis Pharmaceuticals