Actively Recruiting
A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors
Led by ABL Bio, Inc. · Updated on 2025-10-01
96
Participants Needed
3
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (recommended phase 2 dose), pharmacokinetics, immunogenicity, preliminary antitumor activity of ABL103 in subjects with any progressive locally advanced(unresectable) or metastatic solid tumor who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 2 parts: a dose-escalation part and tumor-expansion part
CONDITIONS
Official Title
A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and willing to provide informed consent and comply with study procedures
- 18 years of age or older at time of informed consent
- Histologically confirmed locally advanced unresectable or metastatic solid tumor
- Relapsed or refractory to available standard therapy or intolerant to standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy of at least 12 weeks
- Recovered from prior therapy adverse events to Grade 1 or baseline grade more than 14 days before first ABL103 dose, except stable or irreversible alopecia or Grade 2 toxicities (e.g., peripheral neuropathy)
- Adequate hematologic, renal, hepatic, and thyroid function confirmed by screening labs within 7 days before first ABL103 dose
You will not qualify if you...
- Prior anticancer monoclonal antibody or investigational therapy within 28 days before first study drug dose
- Chemotherapy or radiation therapy within 2 weeks or targeted small molecule therapy within 5 half-lives before first study drug dose
- Systemic steroid or other immunosuppressive therapy within 14 days before study drug administration
- History of drug-induced pneumonitis or current pneumonitis
- Risk factors for bowel obstruction or perforation, such as acute diverticulitis, intra-abdominal abscess, or abdominal carcinomatosis
- Discontinued prior immunomodulatory therapy due to intolerable immune-related adverse events requiring systemic steroids
- Previous treatment with anti-B7-H4 antibody and/or anti-4-1BB antibody
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Seoul National University Bundang Hospital
Seongnam, Seoul, South Korea, 13620
Actively Recruiting
2
Seoul National University Hospital
Seoul, Seoul, South Korea, 03080
Not Yet Recruiting
3
Sevrance Hospital
Seoul, South Korea, South Korea, 03722
Actively Recruiting
Research Team
S
Sangmi Le
CONTACT
J
Jungwoo Choi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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