Solid TumorsPhase 1/2NCT07158918
ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing ABL103, KEYTRUDA® (pembrolizumab) and Taxane in people with Solid Tumors, run by ABL Bio, Inc. at 6 sites in 3 countries.
Trial summary
This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- ABL103, KEYTRUDA® (pembrolizumab) and Taxane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 6 Aug 2025to 2 Dec 2027
- Phase
- Phase 1/2
- 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.
- Subjects must be ≥18 years of age on the day of signing the informed consent form (ICF).
- Subject must have a histologically or cytologically 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 assessed 7 days before the first administration of the study drug.
- 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 (e.g., peripheral neuropathy)
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- Subjects who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Subject with endocrine-related AEs who are adequately treated with hormone replacement or subjects who have ≤Grade 2 neuropathy are eligible.
- Subjects must have adequate hematologic, renal, hepatic, and thyroid function at screening and within 7 days prior to the first administration of study drug.
- Female subjects who are not surgically sterile or postmenopausal must agree to use a highly effective method of birth control (2 methods strongly recommended) during the study and for 6 months following the last dose of ABL103/pembrolizumab.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and within 7 days prior to Cycle 1 Day 1 (C1D1).
- Male subjects with female partner(s) of childbearing potential must agree to use contraception and and must not donate sperm during the treatment period with ABL103 and taxane and for at least 6 months after the final administration of ABL103 and taxane.
- Male subjects with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom throughout the study period, and for at least 6 months after the final administration of ABL103 and taxane, and during the partner's pregnancy or breastfeeding period. When using a male condom, the partner must also use an additional method of contraception acceptable for female subjects.
Who cannot join
- Subject has received prior anticancer monoclonal antibody treatment or investigational therapy (agent or device) for which the pharmacologic or toxicity profile is not expected to have resolved prior to the first administration of the study drug. A minimum of 28 days is generally recommended for agents with known delayed toxicities or prolonged biological activity, unless otherwise justified.
- Subject has received prior radiotherapy within 2 weeks of the first administration of study drug, or has radiation-related toxicities, requiring corticosteroids.
- Subject has received any prior immunotherapy and was discontinued from the treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
- Subject has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study treatment.
- 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. Subjects with ovarian cancer with a history of abdominal carcinomatosis can be enrolled.
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Not yet recruiting
Asan Medical Center
Seoul, 05505
- Not yet recruiting
Samsung Medical Center
Seoul, 06351
United States1 site, 1 recruiting
- Not yet recruiting
UH Cleveland Medical Center
Cleveland, Ohio, 44106
Australia1 site, 1 recruiting
- Not yet recruiting
PASO Medical
Frankston, Victoria, 3199
About this study
Official title: A Multicenter, Open-label, Phase 1b/2 Trial of ABL103, a Bispecific Antibody of B7-H4 and 4-1BB, in Combination With Pembrolizumab With/Without Taxane in Subjects With Selected, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors.
- Conditions
- Solid Tumors
- Being tested
- ABL103, KEYTRUDA® (pembrolizumab), Taxane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABL103Drug
IV infusion
KEYTRUDA® (pembrolizumab)Drug
IV infusion
TaxaneDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| ABL103 (DL1) + pembrolizumab | Experimental | Safety Lead-in Part 1 Receives: Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab) |
| ABL103 (DL2-1) + pembrolizumab + taxane | Experimental | Safety Lead-in Part 2 Receives: Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab); Drug: Taxane |
| ABL103 (DL2) + pembrolizumab + taxane | Experimental | Safety Lead-in Part 2 Receives: Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab); Drug: Taxane |
| Group 1) ABL103 + pembrolizumab + taxane | Experimental | Dose-expansion Part Receives: Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab); Drug: Taxane |
| Group 2) ABL103 + pembrolizumab + taxane | Experimental | Dose-expansion Part Receives: Drug: ABL103; Drug: KEYTRUDA® (pembrolizumab); Drug: Taxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
Measured: Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2)
Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Serious AEs (SAEs), and Infusion-Related Reactions (IRRs)
Measured: From baseline through study completion, an average of 12 months
Recommended Dose for Expansion (RDE) Determination
Measured: From baseline through study completion, an average of 12 months
Objective Response Rate (ORR)
Measured: Up to approximately 30 months
Disease Control Rate (DCR)
Measured: Up to approximately 30 months
Secondary outcomes (3)
Preliminary Objective Response Rate (ORR)
Measured: Up to approximately 30 months
Preliminary Disease Control Rate (DCR)
Measured: Up to approximately 30 months
Incidence of Anti-Drug Antibodies (ADA)
Measured: From baseline through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start6 Aug 2025
- Primary completion2 Dec 2027 (estimated)
- Study completion2 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation and Dose expansion
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ABL Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Sangmi Lee, Study director, ABL Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158918
- Sponsor's protocol ID
- ABL103-1002
- Other IDs
- KEYNOTE-G16, MK-3475-G16
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Phase 1b/2 Trial of ABL103, a Bispecific Antibody of B7-H4 and 4-1BB, in Combination With Pembrolizumab With/Without Taxane in Subjects With Selected, Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07158918
- Acronym / sponsor ID
- ABL103-1002
- Conditions
- Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- ABL Bio, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 2 Dec 2027 (estimated)
- Study completion
- 2 Dec 2027 (estimated)
- First posted
- 8 Sep 2025 (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 study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Dose escalation and Dose expansion
| Arm | Type | Receives |
|---|---|---|
| ABL103 (DL1) + pembrolizumab | Experimental | Drug: ABL103, Drug: KEYTRUDA® (pembrolizumab)Safety Lead-in Part 1 |
| ABL103 (DL2-1) + pembrolizumab + taxane | Experimental | Drug: ABL103, Drug: KEYTRUDA® (pembrolizumab), Drug: TaxaneSafety Lead-in Part 2 |
| ABL103 (DL2) + pembrolizumab + taxane | Experimental | Drug: ABL103, Drug: KEYTRUDA® (pembrolizumab), Drug: TaxaneSafety Lead-in Part 2 |
| Group 1) ABL103 + pembrolizumab + taxane | Experimental | Drug: ABL103, Drug: KEYTRUDA® (pembrolizumab), Drug: TaxaneDose-expansion Part |
| Group 2) ABL103 + pembrolizumab + taxane | Experimental | Drug: ABL103, Drug: KEYTRUDA® (pembrolizumab), Drug: TaxaneDose-expansion Part |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject must understand and be willing to provide informed consent and be able to comply with the study procedures and restrictions.
- Subjects must be ≥18 years of age on the day of signing the informed consent form (ICF).
- Subject must have a histologically or cytologically 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 assessed 7 days before the first administration of the study drug.
Key exclusion criteria (5 listed)
- Subject has received prior anticancer monoclonal antibody treatment or investigational therapy (agent or device) for which the pharmacologic or toxicity profile is not expected to have resolved prior to the first administration of the study drug. A minimum of 28 days is generally recommended for agents with known delayed toxicities or prolonged biological activity, unless otherwise justified.
- Subject has received prior radiotherapy within 2 weeks of the first administration of study drug, or has radiation-related toxicities, requiring corticosteroids.
- Subject has received any prior immunotherapy and was discontinued from the treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
- Subject has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study treatment.
- 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. Subjects with ovarian cancer with a history of abdominal carcinomatosis can be enrolled.
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 |
|---|---|---|
| ABL103IV infusion | Drug | ABL103 (DL1) + pembrolizumab, ABL103 (DL2) + pembrolizumab + taxane, ABL103 (DL2-1) + pembrolizumab + taxane, Group 1) ABL103 + pembrolizumab + taxane, Group 2) ABL103 + pembrolizumab + taxane |
| KEYTRUDA® (pembrolizumab)IV infusion | Drug | ABL103 (DL1) + pembrolizumab, ABL103 (DL2) + pembrolizumab + taxane, ABL103 (DL2-1) + pembrolizumab + taxane, Group 1) ABL103 + pembrolizumab + taxane, Group 2) ABL103 + pembrolizumab + taxane |
| TaxaneIV infusion | Drug | ABL103 (DL2) + pembrolizumab + taxane, ABL103 (DL2-1) + pembrolizumab + taxane, Group 1) ABL103 + pembrolizumab + taxane, Group 2) ABL103 + pembrolizumab + taxane |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2)
Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, Serious AEs (SAEs), and Infusion-Related Reactions (IRRs)
Time frame: From baseline through study completion, an average of 12 months
Recommended Dose for Expansion (RDE) Determination
Time frame: From baseline through study completion, an average of 12 months
Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Disease Control Rate (DCR)
Time frame: Up to approximately 30 months
3 secondary outcomes
Preliminary Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Preliminary Disease Control Rate (DCR)
Time frame: Up to approximately 30 months
Incidence of Anti-Drug Antibodies (ADA)
Time frame: From baseline through study completion, an average of 12 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 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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
ABL Bio
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABL103, KEYTRUDA® (pembrolizumab) and Taxane in people with Solid Tumors, run by ABL Bio, Inc. at 6 sites in 3 countries.
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 12 inclusion and 5 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea, United States, Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Dayoung Ok (+82-2-3456-7300, dayoung.ok@ablbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2)). The study lists 5 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 8 Sep 2025.