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This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects With Any Progressive Locally Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04762641
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
ABL Bio, Inc.

Study Description
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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 2 parts: a dose-escalation part and a dose-expansion part.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: ABL503 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : June 15, 2023
Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Dose-Limiting Toxicity (DLT)

  2. 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 ]
    Number of subjects with Adverse Event, Immune-related Adverse Event, Infusion-related Reactions (IRRs), serious AEs, and abnormalities in lab parameters


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ 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 ]
    Proportion of subject with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1

  2. Pharmacokinetic (PK) of ABL503 [ 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 ]
    Serum concentrations of ABL503 will be collected and analyzed to evaluate the PK of ABL503

  3. Immunogenicity of ABL503 [ 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 ]
    Incidence of anti-ABL503 antibody will be analyzed to evaluate the Immunogenicity of ABL503


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 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
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): NCT04762641


Contacts
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Contact: Juyeun Jeon +82-31-8014-7039 juyeun.jeon@ablbio.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: JuYeon Jeon         
USC Recruiting
Los Angeles, California, United States, 90033
Contact: Juyeun Jeon         
UCLA Recruiting
Santa Monica, California, United States, 90404
Contact: JuYeon Jeon         
United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
Contact: Juyeun Jeon         
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Juyeun Jeon         
Sponsors and Collaborators
ABL Bio, Inc.
More Information
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Responsible Party: ABL Bio, Inc.
ClinicalTrials.gov Identifier: NCT04762641    
Other Study ID Numbers: ABL503-1001
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms