New antibody drug takes aim at Hard-to-Treat cancers
NCT ID NCT06126666
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 96 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Seoul National University Bundang Hospital
RECRUITINGSeongnam, Seoul, 13620, South Korea
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Seoul National University Hospital
NOT_YET_RECRUITINGSeoul, Seoul, 03080, South Korea
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Sevrance Hospital
RECRUITINGSeoul, South Korea, 03722, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors