Testing ABL103 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human Phase 1 clinical trial evaluating ABL103 in patients with advanced or metastatic solid tumors that are either unresectable or have progressed after standard treatments. The study is designed as a single-arm, open-label, multicenter trial that includes a dose-escalation phase to determine the maximum tolerated dose and a tumor-expansion phase to assess preliminary antitumor activity. Participants must have a histologically confirmed diagnosis and meet specific eligibility criteria, including performance status and recovery from previous treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Seoul National University Bundang Hospital
  Seongnam, Seoul, South Korea Recruiting
• Sevrance Hospital
  Seoul, South Korea, South Korea Recruiting
• Seoul National University Hospital
  Seoul, Seoul, South Korea Not yet recruiting

Study contacts

• Study coordinator: Sangmi Le
• Email: sangmi.lee@ablbio.com
• Phone: +82-31-8014-7030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.