Status:
RECRUITING
A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors
Lead Sponsor:
ABL Bio, Inc.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation study of ABL103 to evaluate the safety, tolerability, MTD (maximum tolerated dose) and/or RP2D (re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2027
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06126666
Start Date
November 7 2023
End Date
November 15 2027
Last Update
October 1 2025
Active Locations (3)
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1
Seoul National University Bundang Hospital
Seongnam, Seoul, South Korea, 13620
2
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
3
Sevrance Hospital
Seoul, South Korea, South Korea, 03722