Solid TumorPhase 1ERASERNCT04305249
Safety and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Advanced Solid Tumors and Hematological Malignancies
A Phase 1 study testing ATG-017 and ATG-017+Nivolumab in people with Solid Tumor and Hematological Malignancy, run by Antengene Therapeutics Limited at 5 sites in Australia.
Trial summary
This is a Phase I, multi-center, open-label study of ATG-017 administered orally, alone or in combination with nivolumab in patients with advanced solid tumors and hematological malignancies. The study is composed of two modules: ATG-017 monotherapy (Module A) and ATG-017 in combination with nivolumab (Module B). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Hematological Malignancy
- What is being tested?
- ATG-017 and ATG-017+Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesAustralia
- Study dates
- 15 Aug 2020to 24 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
- Aged at least 18 years.
- Module A: Patient must have a documented activating alteration of the RAS-MAPK pathway.
- Module B: Dose Escalation Phase: Patient must have a documented activating alteration of the RAS-MAPK pathway; Dose Expansion Phase: Expansion cohorts will be further defined based on information from the Dose Escalation.
- Histological or cytological confirmation of a solid tumour.
- Patient with solid tumors must have at least 1 lesion, not previously irradiated.
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- Estimated life expectancy of minimum of 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Ability to swallow and retain oral medication.
Who cannot join
- Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression.
- Prior ATG-017 administration in the present study.
- Prior treatment with an ERK1/2 inhibitor.
- Prior major surgery within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.
- Patients receiving unstable or increasing doses of corticosteroids.
- As judged by the investigator, any evidence of severe or uncontrolled systemic diseases.
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- Active infection including hepatitis B, and/or hepatitis C.
- Known history of human immunodeficiency virus (HIV) infection.
- Inadequate bone marrow reserve or organ function
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002
Austin Hospital
Heidelberg, Victoria, 3084
Alfred Hospital
Melbourne, Victoria, 3004
Scientia Clinical Research
Randwick
Chris O'Brien Lifehouse
Sydney
About this study
Official title: A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Patients With Advanced Solid Tumors and Hematological Malignancies
This is a Phase I, multi-center, open-label study of ATG-017 administered orally, alone or in combination with nivolumab in patients with advanced solid tumors and hematological malignancies. The study is composed of two modules: ATG-017 monotherapy (Module A) and ATG-017 in combination with nivolumab (Module B). Both Modules A and B will include Dose Escalation Phase and Dose Expansion Phase.
Read the detailed description
The dose escalation of ATG 017 will be conducted with intensive safety monitoring to ensure the safety of the patients with solid tumors (Module A and Module B) and hematological malignancies (Module A) harbouring activating alterations in the RAS-MAPK pathway, and will include the continuous and intermittent dosing schedules.
The Dose Expansion Phase will start based on dose level and schedule (continuous or intermittent)
- Conditions
- Solid Tumor, Hematological Malignancy
- Being tested
- ATG-017, ATG-017+Nivolumab
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-017Drug
Also called AZD0364 hemi-adipic acid
Dosing will begin at 5 mg QD ATG-017 as starting dose. A treatment cycle will be 21 days for continuous dosing and 28 days for 7 days on/7 days off intermittent dosing of ATG-017 treatment.
ATG-017+NivolumabDrug
Also called AZD0364 hemi-adipic acid+Opdivo
With the combination with nivolumab, a cycle of study treatment will be defined as 28 days. ATG-017 is planned initially to be continuously given 28 days in each cycle. ATG-017 dosing schedule in combination therapy will follow a similar dose escalation principle as with monotherapy but starting at 5 mg BID. Nivolumab will be specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Module A (ATG-017 Monotherapy) | Experimental | Dosing will begin at 5 mg QD ATG-017 as starting dose. A treatment cycle will be 21 days for continuous dosing and 28 days for 7 days on/7 days off intermittent dosing of ATG-017 treatment. Receives: Drug: ATG-017 |
| Module B (ATG-017+Nivolumab Combination Therapy in Solid Tumors) | Experimental | With the combination with nivolumab, a cycle of study treatment will be defined as 28 days. ATG-017 is planned initially to be continuously given 28 days in each cycle. ATG-017 dosing schedule in combination therapy will follow a similar dose escalation principle as with monotherapy but starting at 5 mg BID. Nivolumab will be given at fixed dosing, 480 mg Q4W, on D1 of each cycle. Receives: Drug: ATG-017+Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs/SAEs
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Measured: 18 months
Secondary outcomes (4)
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
Measured: 18 months
Overall Response Rate (ORR)
To determine the overall response rate according to RECIST1.1, Chenson 2014, IWG 2003 and 2006
Measured: 18 months
DOR
Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented
Measured: 18 months
Progression-Free Survival (PFS)
The time from the first dose date until disease progression or death from any cause
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start15 Aug 2020
- Primary completion11 Apr 2024
- Study completion24 May 2024
Why it stopped: The study was terminated based on the internal need to re-prioritization the whole pipeline and phase 1 portfolio.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antengene Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Sai Lou, MD, Study director, Clinical Research PhysicianAnupa Kudva, MD, Study director, Clinical Research PhysicianYiqiang Zhao, MD, Study director, Executive Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305249
- Sponsor's protocol ID
- ATG-017-001
- Acronym
- ERASER
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2020
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Multi-Center Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Patients With Advanced Solid Tumors and Hematological Malignancies
- ClinicalTrials.gov ID
- NCT04305249
- Acronym / sponsor ID
- ERASER / ATG-017-001
- Conditions
- Solid Tumor, Hematological Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated based on the internal need to re-prioritization the whole pipeline and phase 1 portfolio.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Antengene Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 24 May 2024 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, multi-center, open-label study of ATG-017 administered orally, alone or in combination with nivolumab in patients with advanced solid tumors and hematological malignancies. The study is composed of two modules: ATG-017 monotherapy (Module A) and ATG-017 in combination with nivolumab (Module B). Both Modules A and B will include Dose Escalation Phase and Dose Expansion Phase.
Detailed description
The dose escalation of ATG 017 will be conducted with intensive safety monitoring to ensure the safety of the patients with solid tumors (Module A and Module B) and hematological malignancies (Module A) harbouring activating alterations in the RAS-MAPK pathway, and will include the continuous and intermittent dosing schedules.
The Dose Expansion Phase will start based on dose level and schedule (continuous or intermittent)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Module A (ATG-017 Monotherapy) | Experimental | Drug: ATG-017Dosing will begin at 5 mg QD ATG-017 as starting dose. A treatment cycle will be 21 days for continuous dosing and 28 days for 7 days on/7 days off intermittent dosing of ATG-017 treatment. |
| Module B (ATG-017+Nivolumab Combination Therapy in Solid Tumors) | Experimental | Drug: ATG-017+NivolumabWith the combination with nivolumab, a cycle of study treatment will be defined as 28 days. ATG-017 is planned initially to be continuously given 28 days in each cycle. ATG-017 dosing schedule in combination therapy will follow a similar dose escalation principle as with monotherapy but starting at 5 mg BID. Nivolumab will be given at fixed dosing, 480 mg Q4W, on D1 of each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
- Aged at least 18 years.
- Module A: Patient must have a documented activating alteration of the RAS-MAPK pathway.
- Module B: Dose Escalation Phase: Patient must have a documented activating alteration of the RAS-MAPK pathway; Dose Expansion Phase: Expansion cohorts will be further defined based on information from the Dose Escalation.
- Histological or cytological confirmation of a solid tumour.
Key exclusion criteria (10 listed)
- Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression.
- Prior ATG-017 administration in the present study.
- Prior treatment with an ERK1/2 inhibitor.
- Prior major surgery within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.
- Patients receiving unstable or increasing doses of corticosteroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-017Also: AZD0364 hemi-adipic acidDosing will begin at 5 mg QD ATG-017 as starting dose. A treatment cycle will be 21 days for continuous dosing and 28 days for 7 days on/7 days off intermittent dosing of ATG-017 treatment. | Drug | Module A (ATG-017 Monotherapy) |
| ATG-017+NivolumabAlso: AZD0364 hemi-adipic acid+OpdivoWith the combination with nivolumab, a cycle of study treatment will be defined as 28 days. ATG-017 is planned initially to be continuously given 28 days in each cycle. ATG-017 dosing schedule in combination therapy will follow a similar dose escalation principle as with monotherapy but starting at 5 mg BID. Nivolumab will be specified dose on specified days. | Drug | Module B (ATG-017+Nivolumab Combination Therapy in Solid Tumors) |
Primary outcome
AEs/SAEs
Time frame: 18 months
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
4 secondary outcomes
Plasma concentrations
Time frame: 18 months
Overall Response Rate (ORR)
Time frame: 18 months
DOR
Time frame: 18 months
Progression-Free Survival (PFS)
Time frame: 18 months
Results and safety
The study was stopped early (reason given: The study was terminated based on the internal need to re-prioritization the whole pipeline and phase 1 portfolio.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sai Lou, MD study director
Clinical Research Physician
Anupa Kudva, MD study director
Clinical Research Physician
Yiqiang Zhao, MD study director
Executive Director
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATG-017 and ATG-017+Nivolumab in people with Solid Tumor and Hematological Malignancy, run by Antengene Therapeutics Limited at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated based on the internal need to re-prioritization the whole pipeline and phase 1 portfolio.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs/SAEs (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.