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

Trial Title: A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors

NCT ID: NCT06126666

Condition: Advanced Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ABL103
Description: 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.
Arm group label: ABL103

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

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seongnam
Zip: 13620
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Jeehyun NUB Kim
Email: sangmi.lee@ablbio.com

Investigator:
Last name: Jeehyun Kim
Email: Principal Investigator

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03080
Country: Korea, Republic of

Status: Not yet recruiting

Contact:
Last name: Doyoun NUB Oh
Email: sangmi.lee@ablbio.com

Facility:
Name: Sevrance Hospital

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: SunYoung Rha
Email: sangmi.lee@ablbio.com

Start date: November 7, 2023

Completion date: November 15, 2027

Lead sponsor:
Agency: ABL Bio, Inc.
Agency class: Industry

Source: ABL Bio, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06126666