A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors

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.