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

• Status: Recruiting
• Trial end date: 2023-08-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antengene Therapeutics Limited

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

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