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

NCT ID: NCT06126666

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-07
• Study Completion Date: 2027-11-15

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 (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

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABL103

ABL103 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in tumor-expansion part will be evaluated based on the emerging safety and PK data from the dose-escalation part of the study.

Group Type: EXPERIMENTAL

ABL103

Intervention Type: DRUG

ABL103 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in tumor-expansion part will be evaluated based on the emerging safety and PK data from the dose-escalation part of the study.

Interventions

ABL103

ABL103 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in tumor-expansion part will be evaluated based on the emerging safety and PK data from the dose-escalation part of the study.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ABL Bio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sangmi Lee

Role: STUDY_DIRECTOR

Clinical development team

Locations

Seoul National University Bundang Hospital

Seongnam, Seoul, South Korea

Site Status: RECRUITING

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status: NOT_YET_RECRUITING

Sevrance Hospital

Seoul, South Korea, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sangmi Le

Role: CONTACT

sangmi.lee@ablbio.com

+82-31-8014-7030

Jungwoo Choi

Role: CONTACT

jungwoo.choi@ablbio.com

+82-31-8018-9857

Facility Contacts

Jeehyun NUB Kim

Role: primary

sangmi.lee@ablbio.com

Doyoun NUB Oh

Role: primary

sangmi.lee@ablbio.com

SunYoung Rha

Role: primary

sangmi.lee@ablbio.com

Other Identifiers

ABL103-1001

Identifier Type: -

Identifier Source: org_study_id