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Study of ABL503 for Advanced Solid Tumors

This study is testing a new treatment called ABL503 for people with advanced solid tumors that have progressed or returned after previous treatments, or for which standard treatments are no longer effective. ABL503 is a type of monoclonal antibody (a lab-made protein that can target specific substances in the body). The main goals are to find a safe dose of ABL503, understand its side effects, and see how well it's tolerated. Researchers will also look for early signs of whether ABL503 can help shrink tumors. The study plans to enroll about 100 participants, but its current status is unclear.

Study design
This is a first-in-human, single-arm, open-label study, meaning all participants receive ABL503 and everyone involved knows what treatment is being given. It includes about 100 participants and has dose-escalation and dose-expansion parts.
What's involved
ABL503 will be given intravenously (through a vein) on Day 1 and Day 15 of every 28-day cycle. You will be monitored for side effects and other changes from Day 1 until disease progression, starting a new cancer treatment, or up to about 12 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for side effects and other changes from Day 1 until confirmed complete response, disease progression, starting a new anticancer therapy, unacceptable side effects, or withdrawal of consent, up to approximately 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.

NCT04762641

This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
ABL Bio, Inc.
~100 participants
Updated 2025-02-06 on ClinicalTrials.gov
What's tested:ABL503

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Subjects with Dose-Limiting Toxicities (DLT)
Measured over From Day 1 until disease progression or Day 28, whichever came first
+1 more outcome measured

Conditions

Advanced Solid Tumor

Explore related trials

Solid Neoplasm

NCT04762641

Where you'd take part

This study runs at 8 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

    Recruiting

  • City of Hope

    Duarte, Californiano site contact published

    Recruiting

  • NEXT Oncology

    San Antonio, Texasno site contact published

    Recruiting

  • Sarah Cannon Research Institute at HealthONE

    Denver, Coloradono site contact published

    Recruiting

  • Seoul National University Hospital

    Seoul, South Koreano site contact published

    Recruiting

  • Severance Hospital

    Seoul, South Koreano site contact published

    Recruiting

  • UCLA

    Santa Monica, Californiano site contact published

    Recruiting

  • USC

    Los Angeles, Californiano site contact published

    Recruiting

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

Who to contact

Juyeun Jeon
[email protected]
+82-31-8014-7039
Email the study team

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Eligibility criteria

Inclusion

Histologically and/or cytologically confirmed diagnosis of any progressive locally advanced (unresectable) or metastatic solid tumors that have relapsed or are refractory following the last line of treatment, for which prior standard therapy has been ineffective, standard therapy does not exist, or is not considered appropriate.
With AE(s) excluding alopecia or Grade 2 toxicities that are deemed stable or irreversible (eg, peripheral neuropathy) from prior therapy that have improved to Grade 1 or the baseline grade more than 14 days prior to the first administration of the study drug
Adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory tests and reconfirmed with additional safety laboratory tests performed within 72 hours prior to the first administration of ABL503

Exclusion

Prior anticancer monoclonal antibody treatment or investigational therapy within 28 days prior to the first administration of study drug or has not recovered (ie, ≤ Grade 1 or at baseline grade) from AEs due to previously administered agent more than 14 days prior to ABL503 administration
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 or has not recovered (ie, ≤ Grade 1 or at baseline grade) from AEs due to previously administered agent more than 14 days prior to ABL503 administration
Requiring or received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to study drug administration.
Risk factors for bowel obstruction or bowel perforation (including but not limited to a history of acute diverticulitis, intra-abdominal abscess, and abdominal carcinomatosis.
Discontinued from prior immunomodulatory therapy due to any intolerable immune-related adverse events (IrAEs) requiring systemic steroid treatment
History of drug-induced pneumonitis (interstitial lung disease) or currently has pneumonitis
Received prior treatment with an anti-4-1BB antibody

What this trial measures

  • Number of Subjects with Dose-Limiting Toxicities (DLT)From Day 1 until disease progression or Day 28, whichever came first

    Number of subjects with Dose-Limiting Toxicity (DLT)

  • Number of subjects with AE, IrAEs, IRRs, SAEs and abnormalities in LabFrom Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months

    Number of subjects with Adverse Event, Immune-related Adverse Event, Infusion-related Reactions (IRRs), serious AEs, and abnormalities in lab parameters