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New antibody combo targets Hard-to-Treat cancers in early trial

NCT ID NCT06932952

Disease control Sponsor: Byondis B.V. Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a new antibody called BYON4228, given alone or with the immunotherapy drug pembrolizumab, in people with advanced solid tumors that have not responded to standard treatments. The study includes only 7 participants and aims to check safety, side effects, and whether the tumors shrink. It is too early to know if this approach will work, but it may lead to better options for hard-to-treat cancers.

What this could mean

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

Active substance
BYON4228 (a lab-made antibody) and pembrolizumab (an immunotherapy drug)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 7 participants, so it is too small to prove effectiveness. The treatment may cause side effects or fail to shrink tumors.

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

7 people

The number who actually took part.

Started

May 2025

Expected to finish

Dec 2026

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: * Patient with histologically confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists: * Part 1 (dose escalation): Solid tumors of any origin; * Part 2 (expansion): Patients with other solid tumor types indicated for pembrolizumab monotherapy; * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1; * For Part 2 only: at least one measurable cancer lesion as defined by the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1); * Adequate baseline organ function. Exclusion Criteria: * Having been treated with CD47 or SIRPα targeting agents or other anticancer therapy within 4 weeks prior to the start of IMP treatment; * History of hypersensitivity or allergic reaction to any of the excipients of BYON4228; * Any contraindication to pembrolizumab treatment; * For Part 2: Patients previously given a PD-1 or PD-L1 inhibitor who had subsequent disease progression within 8 weeks of initiation; * Symptomatic brain metastases; * History of autoimmune disorders; * Severe active infection or other severe uncontrolled systemic disease; * Having clinically significant cardiovascular disease; * Known infection of Hepatitis B, C or E. Key inclusion and exclusion criteria details are listed here, additional requirements may apply.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm neoplasm

As listed by the trial registrant

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

Solid tumor

Contacts and locations

Locations

  • CIOCC Hospital Universitario HM Sanchinarro

    Madrid, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Spain

  • Institut Jules Bordet

    Brussels, Belgium

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • The Royal Marsden

    Sutton, United Kingdom

  • UZ Leuven

    Leuven, Belgium

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