We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 )

Tracking Information
First Submitted Date  ICMJE March 5, 2020
First Posted Date  ICMJE March 12, 2020
Last Update Posted Date August 4, 2022
Actual Study Start Date  ICMJE August 15, 2020
Estimated Primary Completion Date May 20, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
AEs/SAEs [ Time Frame: 18 months ]
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • 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
  • Overall Response Rate (ORR) [ Time Frame: 18 months ]
    To determine the overall response rate according to RECIST1.1, Chenson 2014, IWG 2003 and 2006
  • 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
  • Progression-Free Survival (PFS) [ Time Frame: 18 months ]
    The time from the first dose date until disease progression or death from any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 11, 2020)
  • Level of phospho-p90RSK [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of phospho-p90RSK
  • Level of transcript biomarker [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of DUSP6
  • Level of phospho-ERK [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of phospho-ERK
  • Level of total ERK [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of total ERK
Original Other Pre-specified Outcome Measures
 (submitted: March 10, 2020)
  • Level of phospho-p90RSK [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of phospho-p90RSK
  • Level of transcript biomarker [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of DUSP6
  • Level of phospho-ERK and total ERK [ Time Frame: 18 months ]
    Blood samples will be analysed for the level of phospho-ERK and total ERK
 
Descriptive Information
Brief Title  ICMJE Safety and Preliminary Efficacy of ATG-017 Monotherapy in Advanced Solid Tumors and Hematological Malignancies
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Hematological Malignancy
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: ATG-017
Publications * Not Provided

*   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: March 10, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 20, 2023
Estimated Primary Completion Date May 20, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    -

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: Shimin Sun Sun, M.D. 021-23566665 jasmine.sun@antengene.com
Contact: Leng Julia, M.Sc julia.leng@antengene.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04305249
Other Study ID Numbers  ICMJE ATG-017-001
Has Data Monitoring Committee Yes
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 Antengene Corporation ( Antengene Therapeutics Limited )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Antengene Therapeutics Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sai Lou, MD Medical Monitor
PRS Account Antengene Corporation
Verification Date June 2022

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