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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.

Tracking Information
First Submitted Date  ICMJE October 6, 2021
First Posted Date  ICMJE November 1, 2021
Last Update Posted Date January 31, 2024
Actual Study Start Date  ICMJE October 6, 2021
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2021)
  • Number of subjects with dose-limiting toxicities (DLT) [ Time Frame: from Day 1 until Day 28 ]
    Number of subject with dose-limiting toxicities (DLT)
  • 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)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2021)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Drug: ABL501
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumor
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: ABL501
ABL501 will be administered biweekly of every 28-day cycle in the dose-escalation.
Intervention: Drug: ABL501
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2021)		 36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sangmi Lee +82-31-8014-7030 sangmi.lee@ablbio.com
Contact: Jooyeon Park +82-31-8014-7026 jooyeon.park@ablbio.com
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05101109
Other Study ID Numbers  ICMJE ABL501-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party ABL Bio, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ABL Bio, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sangmi Lee Clinical development team
PRS Account ABL Bio, Inc.
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP