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New drug combo takes on Hard-to-Treat cancers

NCT ID NCT06480552

Disease control Sponsor: Teva Branded Pharmaceutical Products R&D LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests an experimental drug called TEV-56278, alone or with the immunotherapy pembrolizumab, in 240 people with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety, find the right dose, and see if the drug can shrink tumors. Participants will be treated for up to 12 months, with possible extension.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TEV-56278 (an experimental drug) and pembrolizumab (a cancer immunotherapy)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is an early Phase 1 trial with only 240 participants, so the drug may not prove effective or safe enough to advance. Side effects are unknown and could be serious.

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

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Feb 2031

An estimate. End dates often move.

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 years and older

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: * Have an established histological diagnosis of selected solid tumor and must have received and progressed on established standard therapies or have been intolerant to such therapy or have been considered by the Investigator as ineligible for approved standard therapy * Have a life expectancy≥12 weeks at the time of the screening * Women of childbearing potential must agree to use highly effective methods of contraception for the course of the trial through 120 days after the last dose of trial medication * Males who are sexually active with women of childbearing potential must agree to use condoms and refrain from donating sperm for the course of the trial through 120 days after the last dose of trial medication NOTE- Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * Has a history of systemic treatment therapy for cancer (including chemotherapy, immunotherapy, radiotherapy, or other investigational drug) or surgery within 4 weeks prior to baseline * Is currently receiving or has received hematopoietic colony-stimulating growth factors within 2 weeks before screening or transfusion support 4 weeks prior to screening * Has a diagnosis of immunodeficiency * Has active known autoimmune disease. * Has a history of or known active brain metastases and/or carcinomatous meningitis and/or leptomeningeal metastasis * Has active or uncontrolled serious infections requiring systemic therapy within 14 days prior to baseline * Has a history of clinically significant cardiovascular or cerebrovascular disease in previous 6 months prior to screening * Has evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis * Has a seizure disorder requiring therapy (such as steroids or antiepileptics) NOTE- Additional criteria apply, please contact the investigator for more information

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Teva Investigational Site 11282

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Teva Investigational Site 12014

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Teva Investigational Site 12015

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Teva Investigational Site 12016

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Teva Investigational Site 12017

    RECRUITING

    Los Angeles, California, 90025, United States

  • Teva Investigational Site 12018

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Teva Investigational Site 12019

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Teva Investigational Site 12021

    COMPLETED

    Lake Mary, Florida, 32746, United States

  • Teva Investigational Site 12023

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Teva Investigational Site 12024

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Teva Investigational Site 12025

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Teva Investigational Site 12058

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

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