Clinical trial NCT06126666: A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors
Official title: A Phase 1 Dose Escalation and Expansion Study of ABL103, a Bispecific Antibody of 4-1BB and B7-H4, as a Single Agent in Subjects With Any Progressive Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: ABL Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of subjects with Dose-Limiting Toxicities (DLT)
timeFrame: From Day 1 until disease progression or Day 28
measure: Number of subjects with Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and immune-related Adverse Events (irAEs)
timeFrame: From Day 1 until confirmed Complete Response (CR), disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first
measure: Number of subjects with Treatment-emergent Infusion related reactions (IRRs)
timeFrame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first
measure: Number of subjects with the changes from baseline in laboratory values
timeFrame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first
Secondary outcomes:
measure: Pharmacokinetic profile of ABL103
timeFrame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to 24 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Sevrance Hospital
state: South Korea
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Clinical development team
name: Sangmi Lee
role: STUDY_DIRECTOR
References: