Evaluating ABL503 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial is designed to assess the safety and tolerability of ABL503 in patients with progressive locally advanced or metastatic solid tumors that have not responded to previous treatments. The study will involve a single-arm, open-label approach with multiple doses, focusing on determining the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). It includes a dose-escalation phase, a dose-expansion phase, and a tumor-expansion phase to evaluate the drug's pharmacokinetics, immunogenicity, and preliminary antitumor activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• USC
  Los Angeles, California, United States Recruiting
• UCLA
  Santa Monica, California, United States Recruiting
• Sarah Cannon Research Institute at HealthONE
  Denver, Colorado, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Juyeun Jeon
• Email: juyeun.jeon@ablbio.com
• Phone: +82-31-8014-7039

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.