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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

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ClinicalTrials.gov Identifier: NCT05101109
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
ABL Bio, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: ABL501 Phase 1

Detailed Description:
This is consisted with dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, anti-tumor activity, and the PD effect of ABL501 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Drug: ABL501
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation and Expansion Study of ABL501, a Bispecific Antibody of PD-L1 and LAG-3 as a Single Agent in Subjects With Any Progressive, Locally Advanced (Unresectable) or Metastatic Solid Tumors
Actual Study Start Date : October 6, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ABL501
ABL501 will be administered biweekly of every 28-day cycle in the dose-escalation.
 Drug: ABL501
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.
Other Name: Bispecific antibody for LAG-3 and PD-L1


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with dose-limiting toxicities (DLT) [ Time Frame: from Day 1 until Day 28 ]
    Number of subject with dose-limiting toxicities (DLT)

  2. Number of subjects who experience with TEAEs, SAEs, irAEs and IRRs [ Time Frame: 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-emergent adverse events (TEAEs), Serious adverse events (SAEs), immune-related adverse events (irAEs) and infusion related reactions (IRRs)

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

  4. Number of subjects who experience with clinically significant changes in laboratory values [ Time Frame: 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


Secondary Outcome Measures :
  1. Pharmacokinetic profile of ABL501 [ Time Frame: 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 ]
    serum concentration of ABL501 will be collected and analyzed to evaluate the PK of ABL501

  2. Objective Response Rate (ORR) [ Time Frame: 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 ]
    Proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1

  3. number of subject with anti-drug antibodies (ADAs) [ Time Frame: 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 ]
    Incidence of anti-drug antibodies (ADAs) will be analyzed to evaluate the immunogenicity of ABL501


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05101109


Contacts
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Contact: Sangmi Lee +82-31-8014-7030 sangmi.lee@ablbio.com
Contact: Jooyeon Park +82-31-8014-7026 jooyeon.park@ablbio.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: DoYoun Oh       sangmi.lee@ablbio.com   
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: SunYoung Rha       sangmi.lee@ablbio.com   
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of, 05505
Contact: Daeho Lee       sangmi.lee@ablbio.com   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Myeongju Ahn       sangmi.lee@ablbio.com   
Sponsors and Collaborators
ABL Bio, Inc.
Investigators
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Study Director: Sangmi Lee Clinical development team
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ABL Bio, Inc.
ClinicalTrials.gov Identifier: NCT05101109    
Other Study ID Numbers: ABL501-1001
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ABL Bio, Inc.:
LAG-3
PD-L1
Immune oncology
solid tumor
bispecific antibody
Additional relevant MeSH terms:
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Neoplasms
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs