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New cancer drug QEQ278 tested in Early-Stage trial

NCT ID NCT05462873

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a new drug, QEQ278, in 30 adults with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check the drug's safety and find the right dose. The study was stopped early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

30 people

The number who actually took part.

Started

Apr 2023

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Massachusetts General Hospital Dept. of Mass General Hospital

    Boston, Massachusetts, 02114, United States

  • Novartis Investigative Site

    Brussels, 1200, Belgium

  • Novartis Investigative Site

    Paris, 75231, France

  • Novartis Investigative Site

    Essen, 45147, Germany

  • Novartis Investigative Site

    Milan, MI, 20133, Italy

  • Novartis Investigative Site

    Kashiwa, Chiba, 2778577, Japan

  • Novartis Investigative Site

    Singapore, 168583, Singapore

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Taipei, 10002, Taiwan

  • University of California LA

    Los Angeles, California, 90095, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.