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New antibody drug takes aim at Hard-to-Treat cancers

NCT ID NCT06126666

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new drug called ABL103 in people with advanced solid tumors that have not responded to standard treatments. The drug is a bispecific antibody designed to help the immune system attack cancer cells. The study will enroll 96 participants to evaluate safety, dosing, and any signs of tumor shrinkage.

What this could mean

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

Active substance
ABL103 (a bispecific antibody that targets two proteins on cancer cells to boost immune response)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 96 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause side effects.

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 96 people

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

Started

Nov 2023

Expected to finish

Nov 2027

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: * Subject must understand and be willing to provide informed consent and be able to comply with the study procedures and restrictions. * Subject must be ≥18 years of age on the day of signing the informed consent form (ICF) * Subject must have a histologically confirmed locally advanced unresectable, or metastatic solid tumor. * Subject must be relapsed or be refractory to available standard therapy or they must be intolerant of available standard therapy. * Subject must meet Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Subject must have an estimated life expectancy of at least 12 weeks. * Subjects must be recovered from AEs from prior therapy to Grade 1 or the baseline grade more than 14 days prior to the first administration of the study drug, except alopecia or Grade 2 toxicities that are deemed stable or irreversible (eg, peripheral neuropathy) * Subjects must have adequate hematologic, renal, hepatic, and thyroid functions confirmed based on the screening laboratory test within 7 days prior to the first administration of ABL103. Exclusion Criteria: * Subject has received prior anticancer monoclonal antibody treatment or investigational therapy within 28 days prior to the first administration of study drug. * Subject has received prior chemotherapy or radiation therapy within 2 weeks or targeted small molecule therapy within 5 half-lives prior to the first administration of study drug. * Subject requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration. * Subject has a history of drug-induced pneumonitis (interstitial lung disease) or currently has pneumonitis. * Subject has risk factors for bowel obstruction or bowel perforation, including, but not limited to a history of acute diverticulitis, intra-abdominal abscess, and abdominal carcinomatosis. * Subject discontinued from prior immunomodulatory therapy due to any intolerable immune-related adverse events (irAEs) requiring systemic steroid treatment. * Subject has received prior treatment with anti-B7-H4 antibody and/or anti-4-1BB antibody.

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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.

How to take part

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

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, Seoul, 13620, South Korea

  • Seoul National University Hospital

    NOT_YET_RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Sevrance Hospital

    RECRUITING

    Seoul, South Korea, 03722, South Korea

More trials for these conditions

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