COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04305249




Registration number
NCT04305249
Ethics application status
Date submitted
5/03/2020
Date registered
12/03/2020
Date last updated
18/11/2020

Titles & IDs
Public title
Safety and Preliminary Efficacy of ATG-017 Monotherapy in Advanced Solid Tumors and Hematological Malignancies
Scientific 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
Secondary ID [1] 0 0
ATG-017-001
Universal Trial Number (UTN)
Trial acronym
ERASER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Hematological Malignancy 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ATG-017

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.


Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AEs/SAEs - Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Plasma concentrations - 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
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Overall Response Rate (ORR) - To determine the overall response rate according to RECIST1.1, Chenson 2014, IWG 2003 and 2006
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
DOR - Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Progression-Free Survival (PFS) - The time from the first dose date until disease progression or death from any cause
Timepoint [4] 0 0
18 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

-

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Scientia Clinical Research - Randwick
Recruitment hospital [5] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment postcode(s) [5] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Antengene Therapeutics Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04305249
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jiao Kuang, MD
Address 0 0
Medical Monitor
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shimin Sun Sun, M.D.
Address 0 0
Country 0 0
Phone 0 0
021-23566665
Fax 0 0
Email 0 0
jasmine.sun@antengene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04305249