Testing ABL103 in patients with advanced solid tumors

A Phase 1 Dose Escalation and Expansion Study of ABL103, a Bispecific Antibody of 4-1BB and B7-H4, as a Single Agent in Subjects With Any Progressive Locally Advanced or Metastatic Solid Tumors

This study is testing a new treatment called ABL103 to see if it can help people with advanced solid tumors that haven't responded to other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ABL Bio, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Seongnam, Seoul and 2 other locations)
• Trial ID: NCT06126666 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic solid tumors that are relapsed or refractory to standard therapies.

Not a fit: Patients with early-stage tumors or those who have not yet received standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have no available standard care.

How similar studies have performed: Other studies involving similar dose-escalation approaches for advanced solid tumors have shown promise, but this specific treatment is novel.

Eligibility criteria

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 this trial is running

Seongnam, Seoul and 2 other locations

• Seoul National University Bundang Hospital — Seongnam, Seoul, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, Seoul, South Korea (Not_yet_recruiting)
• Sevrance Hospital — Seoul, South Korea, South Korea (Recruiting)

Study contacts

• Study coordinator: Sangmi Le

Conditions Advanced Solid Tumor