Status:
TERMINATED
Safety and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Advanced Solid Tumors and Hematological Malignancies
Lead Sponsor:
Antengene Therapeutics Limited
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Solid Tumor
Hematological Malignancy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 stud...
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- Active infection including hepatitis B, and/or hepatitis C.
- Known history of human immunodeficiency virus (HIV) infection.
- Inadequate bone marrow reserve or organ function
- \-
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04305249
Start Date
August 15 2020
End Date
May 24 2024
Last Update
July 23 2024
Active Locations (5)
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1
Peter MacCallum Cancer Centre
East Melbourne, Victoria, Australia, 3002
2
Austin Hospital
Heidelberg, Victoria, Australia, 3084
3
Alfred Hospital
Melbourne, Victoria, Australia, 3004
4
Scientia Clinical Research
Randwick, Australia