Evaluating ABL503 for advanced solid tumors

A Phase 1 Dose Escalation and Expansion Study of ABL503, a Bispecific Antibody of 4-1BB and PD-L1, As a Single Agent in Subjects with Any Progressive Locally Advanced (unresectable) or Metastatic Solid Tumors

This study is testing a new drug called ABL503 to see if it is safe and can help people with advanced solid tumors that haven't improved with other treatments.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ABL Bio, Inc. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 8 sites (Duarte, California and 7 other locations)
• Trial ID: NCT04762641 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals with histologically confirmed advanced solid tumors that are relapsed or refractory to previous treatments and have no available standard care options.

Not a fit: Patients who have received prior anticancer monoclonal antibody treatment or investigational therapy within 28 days prior to the study will not benefit from this trial.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: Other studies evaluating similar investigational therapies for advanced solid tumors have shown promise, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Duarte, California and 7 other locations

• 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)
• Severance Hospital — Seoul, South Korea (RECRUITING)
• Asan Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Juyeun Jeon

Conditions: Advanced Solid Tumor