Advanced Solid TumorPhase 1NCT06126666
A Study With ABL103 in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1 study testing ABL103 in people with Advanced Solid Tumor, run by ABL Bio, Inc. at 3 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- ABL103
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 7 Nov 2023to 15 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Seoul, 13620
Jeehyun NUB Kim, sangmi.lee@ablbio.com
Jeehyun Kim
- Not yet recruiting
Seoul National University Hospital
Seoul, Seoul, 03080
Doyoun NUB Oh, sangmi.lee@ablbio.com
- Recruiting
Sevrance Hospital
Seoul, South Korea, 03722
SunYoung Rha, sangmi.lee@ablbio.com
About this study
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
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
- Being tested
- ABL103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABL103Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| ABL103 | Experimental | 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. Receives: Drug: ABL103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Dose-Limiting Toxicities (DLT)
Number of subjects with Dose-Limiting Toxicities (DLT)
Measured: From Day 1 until disease progression or Day 28
Number of subjects with Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and immune-related Adverse Events (irAEs)
Number of subjects with Treatment-emergent AEs, SAEs and irAEs
Measured: 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
Number of subjects with Treatment-emergent Infusion related reactions (IRRs)
Number of subjects with Treatment-emergent IRRs
Measured: 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
Number of subjects with the changes from baseline in laboratory values
Number of subjects with the changes from baseline in laboratory values
Measured: 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 (1)
Pharmacokinetic profile of ABL103
serum concentration of ABL103 will be collected and analyzed to evaluate the PK of ABL103
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start7 Nov 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ABL Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sangmi Lee, Study director, Clinical development team
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126666
- Sponsor's protocol ID
- ABL103-1001
- Status last verified
- Sep 2025
- First submitted
- 2 Nov 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06126666
- Acronym / sponsor ID
- ABL103-1001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- ABL Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABL103 | Experimental | Drug: ABL103ABL103 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABL103ABL103 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. | Drug | ABL103 |
Primary outcome
Number of subjects with Dose-Limiting Toxicities (DLT)
Time frame: From Day 1 until disease progression or Day 28
Number of subjects with Dose-Limiting Toxicities (DLT)
Number of subjects with Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and immune-related Adverse Events (irAEs)
Time frame: 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
Number of subjects with Treatment-emergent AEs, SAEs and irAEs
Number of subjects with Treatment-emergent Infusion related reactions (IRRs)
Time frame: 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
Number of subjects with Treatment-emergent IRRs
Number of subjects with the changes from baseline in laboratory values
Time frame: 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
Number of subjects with the changes from baseline in laboratory values
1 secondary outcome
Pharmacokinetic profile of ABL103
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sangmi Lee study director
Clinical development team
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABL103 in people with Advanced Solid Tumor, run by ABL Bio, Inc. at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sangmi Le (+82-31-8014-7030, sangmi.lee@ablbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Dose-Limiting Toxicities (DLT) (time frame: From Day 1 until disease progression or Day 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.