Recruiting
Phase 1

ABL503

Sponsor:

ABL Bio, Inc.

Code:

NCT04762641

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ABL503

Study Details

Brief summary:

This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 3 parts: a dose-escalation part, a dose-expansion part and tumor-expansion part

Conditions

Advanced Solid Tumor

Study ID

NCT04762641

Start date

Apr 1, 2021

Status verified date

Jan, 2025

Completion date

Jun 15, 2026

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABL503

ABL503 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in the dose-expansion part will be re-evaluated based on the emerging safety and PK data from the dose-escalation part of the study.

Interventions

ABL503

ABL503 will be administered intravenously (IV) on Day 1 and Day 15 of every 28-day cycle in the dose-escalation part. The dosing interval to be used in the dose-expansion part will be re-evaluated based on the emerging safety and PK data from the dose-escalation part of the study.

Primary outcome measure

  • Number of Subjects with Dose-Limiting Toxicities (DLT) [ Time Frame: From Day 1 until disease progression or Day 28, whichever came first ]
  • Number of subjects with AE, IrAEs, IRRs, SAEs and abnormalities in Lab [ Time Frame: From 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 ]

Central Contacts and Locations

Central contacts

Juyeun Jeon

+82-31-8014-7039juyeun.jeon@ablbio.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

USC

Recruiting

LA, California, United States, 90033

UCLA

Recruiting

Santa Monica, California, United States, 90404

Sarah Cannon Research Institute at HealthONE

Recruiting

Denver, Colorado, United States, 80218

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

ABL Bio, Inc.

Last update posted

Feb 6, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ABL Bio, Inc. on 2025-02-06.