Study to Evaluate the Safety and Tolerability of ABL501, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL501 in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors

NCT05101109 | Completed Phase 1

• 1 other identifier: ABL501-1001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

Brief Summary

This is a first-in-human (FIH) phase 1 open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary anti-tumor activity, and the PD effect of ABL501 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors. This study included 2 parts; a dose-escalation part and a dose expansion part.

Conditions

Advanced Solid Tumor

Keywords

LAG-3; PD-L1; Immune oncology; solid tumor; bispecific antibody

Outcome Measures

Primary Outcomes (4)

• Number of subjects with dose-limiting toxicities (DLT)

  Number of subject with dose-limiting toxicities (DLT)

  from Day 1 until Day 28

• Number of subjects who experience with TEAEs, SAEs, irAEs and IRRs

  Number of subjects who experience with Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), immune-related adverse events (irAEs) and infusion related reactions (IRRs)

  From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months

• Number of subjects who experience with treatment-related TEAEs, SAEs, irAEs and IRRs

  Number of subjects who experience with treatment-related Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), immune-related adverse events (irAEs) and infusion related reactions (IRRs)

  From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months

• Number of subjects who experience with clinically significant changes in laboratory values

  Number of subjects who experience with clinically significant changes in laboratory values

  From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months

Secondary Outcomes (3)

• Pharmacokinetic profile of ABL501

  From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months

• Objective Response Rate (ORR)

  From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months

• number of subject with anti-drug antibodies (ADAs)

  From Day 1 until confirmed CR, disease progression, unacceptable toxicity or subject/investigator's decision to terminate the study participation, assessed up to 24 months

Study Arms (1)

ABL501

EXPERIMENTAL

ABL501 will be administered biweekly of every 28-day cycle in the dose-escalation.

Drug: ABL501

Interventions

ABL501 DRUG

ABL501 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.

Also known as: Bispecific antibody for LAG-3 and PD-L1

ABL501

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, standard therapy does not exist, or is not considered appropriate.
• Subjects with adverse events(AEs) excluding alopecia or Grade 2 toxicities that are deemed stable or irreversible (e.g., 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 study drug.
• Subject with adequate hematologic, hepatic, and renal functions confirmed based on the screening laboratory test within 7 days prior to the first administration of ABL501

You may not qualify if:

• Subjects has received prior anticancer monoclonal antibody treatment or investigational therapy within 28 days prior to the first administration of ABL501 or who has recovered (i.e., =\<Grade 1 or at baseline grade) from AEs due to previously administered agent more than 14 days prior to ABL501 administration.
• Subject has had 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 (i.e., =\<Grade 1 or at baseline grade) from AEs due to previously administered agent more than 14 days prior to ABL501 administration
• Subject discontinued from prior immunomodulatory therapy due to any intolerable immune-related AE(s) (irAEs) requiring systemic steroid treatment.

Sponsors & Collaborators

• ABL Bio, Inc.: lead

Study Sites (4)

Seoul National University Bundang Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

• Sung E, Ko M, Won JY, Jo Y, Park E, Kim H, Choi E, Jung UJ, Jeon J, Kim Y, Ahn H, Choi DS, Choi S, Hong Y, Park H, Lee H, Son YG, Park K, Won J, Oh SJ, Lee S, Kim KP, Yoo C, Song HK, Jin HS, Jung J, Park Y. LAG-3xPD-L1 bispecific antibody potentiates antitumor responses of T cells through dendritic cell activation. Mol Ther. 2022 Aug 3;30(8):2800-2816. doi: 10.1016/j.ymthe.2022.05.003. Epub 2022 May 6.

  PMID: 35526096 DERIVED

MeSH Terms

Interventions

Antibodies, Bispecific

Intervention Hierarchy (Ancestors)

Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sangmi Lee

  Clinical development team

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Drug: ABL501

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 1, 2021
• Study Start: October 6, 2021
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)