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ABL103 with Pembrolizumab for Advanced Solid Tumors

This study is testing a new combination of treatments for people with advanced or metastatic solid tumors (cancers that have spread). It will look at the safety and effectiveness of ABL103 given with KEYTRUDA® (pembrolizumab), sometimes also including a taxane. The main goals are to see how safe the treatment is, including any side effects, and to determine the best dose for future studies. You may be able to join if you are 18 or older and have a confirmed advanced or metastatic solid tumor. The study plans to enroll about 65 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 65 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored from baseline through study completion, which is an average of 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07158918

ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
ABL Bio, Inc.
~65 participants
Updated 2025-09-08 on ClinicalTrials.gov
What's tested:ABL103KEYTRUDA® (pembrolizumab)Taxane

At a glance

Recruiting sites
2 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose-Limiting Toxicities (DLTs)
Measured over Day 1 to Day 21 (Safety Lead-in Part 1) and Day 1 to Day 28 (Safety Lead-in Part 2)
+4 more outcomes measured

Conditions

Solid Tumors

Explore related trials

Solid Neoplasm

NCT07158918

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Asan Medical Center

    Seoul, South Koreano site contact published

    Not yet recruiting

  • PASO Medical

    Frankston, Victoria, Australiano site contact published

    Not yet recruiting

  • Samsung Medical Center

    Seoul, South Koreano site contact published

    Not yet recruiting

  • Seoul National University Bundang Hospital

    Seongnam, South Koreano site contact published

    Recruiting

  • Seoul National University Hospital

    Seoul, South Koreano site contact published

    Recruiting

  • UH Cleveland Medical Center

    Cleveland, Ohiono site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sangmi Lee · STUDY_DIRECTOR · ABL Bio

Who to contact

Dayoung Ok
[email protected]
+82-2-3456-7300
Email the study team

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Eligibility criteria

Inclusion

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)
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.

Exclusion

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.

What this trial measures

  • Incidence of Dose-Limiting Toxicities (DLTs)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)From baseline through study completion, an average of 12 months
  • Recommended Dose for Expansion (RDE) DeterminationFrom baseline through study completion, an average of 12 months
  • Objective Response Rate (ORR)Up to approximately 30 months
  • Disease Control Rate (DCR)Up to approximately 30 months