Part 2: Dose expansion for Esophageal Cancer

Phase-Based Progress Estimates
Novartis Investigative Site, Taipei, TaiwanEsophageal Cancer+16 MoreQEQ278 - Biological
All Sexes
What conditions do you have?

Study Summary

This trial tests the safety & effectiveness of a drug to treat advanced cancers including lung, esophageal, renal and head/neck cancer.

Eligible Conditions
  • Esophageal Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Renal Cell Carcinoma
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Study Objectives

4 Primary · 12 Secondary · Reporting Duration: Up to 31 months

28 days
Incidence and nature of Dose Limiting Toxicities (DLTs) during the DLT evaluation period for single agent QEQ278
Day 1 and 15
Incidence of anti-drug antibody (ADA)
Day 168
Area under the concentration time curve (AUC) infinity of QEQ278
Area under the concentration time curve (AUC) last of QEQ278
Elimination half-life (T1/2) of QEQ278
Time to reach peak serum concentration (Tmax) of QEQ278
Total body clearance (CL) of QEQ278
Volume of distribution (Vz) of QEQ278
Up to 30 months
Disease control rate (DCR) per RECIST v1.1
Dose intensity
Duration of Response (DOR) per RECIST v1.1
Frequency of dose interruptions, reductions
Overall response rate (ORR) per RECIST v1.1
Progression-free survival (PFS) per RECIST v 1.1
Up to 31 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Trial Safety

Trial Design

2 Treatment Groups

Part 2: Dose expansion
1 of 2
Part 1: Dose escalation
1 of 2

Experimental Treatment

125 Total Participants · 2 Treatment Groups

Primary Treatment: Part 2: Dose expansion · No Placebo Group · Phase 1

Part 2: Dose expansion
Experimental Group · 1 Intervention: QEQ278 · Intervention Types: Biological
Part 1: Dose escalation
Experimental Group · 1 Intervention: QEQ278 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 31 months

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,738 Previous Clinical Trials
3,544,089 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a specific type of lung cancer called non-small cell lung cancer.
You have kidney cancer.

Frequently Asked Questions

Has Part 2: Dose Expansion of this project been granted clearance by the U.S. Food and Drug Administration?

"Our team at Power has judged Part 2: Dose Expansion to have a score of 1 due to its Phase 1 status, which implies limited pre-existing evidence verifying the medication's safety and efficacy." - Anonymous Online Contributor

Unverified Answer

Are medical professionals currently looking for participants in this trial?

"Affirmative, the data hosted on indicates that this medical research is currently seeking new participants. This trial was initially published on January 31st 2023 and has been updated most recently by January 11th of the same year. 125 people are expected to join at one location for this project." - Anonymous Online Contributor

Unverified Answer

What are the fundamental aims of this experiment?

"Novartis Pharmaceuticals, the sponsor of this study, has outlined that over a 30-month period they will be assessing Frequency of dose interruptions and reductions as its primary outcome. Additionally, secondary objectives such as Elimination half-life (T1/2) of QEQ278, Total body clearance (CL)of QEQ278, and Volume of distribution (Vz)of QEQ278 will also be evaluated." - Anonymous Online Contributor

Unverified Answer

What is the approximate number of participants enrolled in this clinical experiment?

"Yes, according to the latest information on, this experiment is presently recruiting patients for participation. The research commenced on January 31st 2023 and was recently updated on January 11th 2023; with a need of 125 individuals from one site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.