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Safety and Preliminary Efficacy of ATG-017 Monotherapy in Advanced Solid Tumors and Hematological Malignancies (ERASER)

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: NCT04305249
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : August 4, 2022
Sponsor:
Information provided by (Responsible Party):
Antengene Corporation ( Antengene Therapeutics Limited )

Brief Summary:
This is a Phase I, multi-center, open-label study of ATG-017 administered orally, alone in patients with advanced solid tumors and hematological malignancies. The study design includes a Dose Escalation Phase and Dose Expansion Phase.

Condition or disease Intervention/treatment Phase
Solid Tumor Hematological Malignancy Drug: ATG-017 Phase 1

Detailed Description:
The dose escalation of ATG 017 with intensive safety monitoring to ensure the safety of the patients with solid tumors (solid tumors group) and hematological malignancies (hematological malignancies group) harbouring activating alterations in the RAS-MAPK pathway. Dose Expansion Phase will begin at the defined maximum tolerated dose (MTD) and/or biologically effective dose and/or other dose, in order to further evaluate the safety, tolerability and PDx of ATG 017. Patients with solid tumors or hematological malignancies harbouring activating alterations in the RAS-MAPK pathway will be enrolled.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy in Patients With Advanced Solid Tumors and Hematological Malignancies
Actual Study Start Date : August 15, 2020
Estimated Primary Completion Date : May 20, 2023
Estimated Study Completion Date : August 20, 2023

Arm Intervention/treatment
Experimental: ATG-017
ATG-017 will be administered orally on an empty stomach QD in the first cohort of solid tumors group and BID 12 hours apart (no food or drink other than water for 2 hours prior to, and for 1 hour after study treatment administration) in other cohorts. All doses of ATG-017 should be taken at approximately the same time each day. Patients will receive study treatment in 21-day cycles.
Drug: ATG-017
Dosing will begin at 5 mg once a day (QD) ATG-017 as starting dose. A cycle of study treatment will be defined as 21 days.
Other Name: AZD0364 hemi-adipic acid




Primary Outcome Measures :
  1. AEs/SAEs [ Time Frame: 18 months ]
    Toxicity will be graded according to the NCI CTCAE, Version 5.0.


Secondary Outcome Measures :
  1. Plasma concentrations [ Time Frame: 18 months ]
    Venous blood samples for determination of total concentrations of ATG 017 in plasma to characterise the PK profile of ATG-017 for a particular dose level

  2. Overall Response Rate (ORR) [ Time Frame: 18 months ]
    To determine the overall response rate according to RECIST1.1, Chenson 2014, IWG 2003 and 2006

  3. DOR [ Time Frame: 18 months ]
    Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented

  4. Progression-Free Survival (PFS) [ Time Frame: 18 months ]
    The time from the first dose date until disease progression or death from any cause


Other Outcome Measures:
  1. Level of phospho-p90RSK [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of phospho-p90RSK

  2. Level of transcript biomarker [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of DUSP6

  3. Level of phospho-ERK [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of phospho-ERK

  4. Level of total ERK [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of total ERK



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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:

  1. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
  2. Aged at least 18 years.
  3. Patient must have a documented activating alteration of the RAS-MAPK pathway.
  4. Histological or cytological confirmation of a solid tumour.
  5. Patients with hematological malignancies.
  6. Patient with solid tumors must have at least 1 lesion, not previously irradiated.
  7. Estimated life expectancy of minimum of 12 weeks.
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  9. Ability to swallow and retain oral medication.

Exclusion Criteria:

  1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression.
  2. Prior ATG-017 administration in the present study.
  3. Prior treatment with an ERK1/2 inhibitor.
  4. Prior major surgery within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.
  5. Patients receiving unstable or increasing doses of corticosteroids.
  6. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.
  7. Active infection including hepatitis B, and/or hepatitis C.
  8. Known history of human immunodeficiency virus (HIV) infection.
  9. Inadequate bone marrow reserve or organ function

    -


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): NCT04305249


Contacts
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Contact: Shimin Sun Sun, M.D. 021-23566665 jasmine.sun@antengene.com
Contact: Leng Julia, M.Sc julia.leng@antengene.com

Locations
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Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Victoria, Australia, 3002
Principal Investigator: Ben Tran         
Principal Investigator: Jayesh Desai         
Austin Hospital Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Hui Gan         
Principal Investigator: Hui Gan         
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Mark Voskoboynik         
Principal Investigator: Mark Voskoboynik         
Australia
Scientia Clinical Research Recruiting
Randwick, Australia
Contact: Charlotte Lemech         
Chris O'Brien Lifehouse Recruiting
Sydney, Australia
Contact: Lisa Horvath         
Sponsors and Collaborators
Antengene Therapeutics Limited
Investigators
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Study Director: Sai Lou, MD Medical Monitor
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Responsible Party: Antengene Therapeutics Limited
ClinicalTrials.gov Identifier: NCT04305249    
Other Study ID Numbers: ATG-017-001
First Posted: March 12, 2020    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: June 2022
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
Additional relevant MeSH terms:
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Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases