NCT05338346

A Study of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies

A Phase I, Open-Label, Multi-Center, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Antengene Discovery Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I, Open-Label, Multi-Center, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-018 (ATR inhibitor) Treatment in Patients with Advanced Solid Tumors and Hematological Malignancies .

Detailed description

This is a Phase I, multi-center, open-label study of ATG-018 administered orally as monotherapy in patients with advanced solid tumors and hematological malignancies. The study design includes a Dose Escalation Phase and a Dose Expansion Phase.

Conditions

• Advanced Solid Tumors
• Hematological Malignancies

Interventions

Type	Name	Description
DRUG	ATG-018	Dose Escalation Phase: For both dose escalation groups, subjects will receive a single dose of ATG-018 monotherapy on Cycle 1 Day 1 (C1D1) for single dose PK samples' collection. From the morning dose on Cycle 1 Day 2, twice daily dosing (except Dose Level 1: 5 mg QD) will be initiated. Subject(s) will receive intermittent dosing in a 3 days on/4 days off schedule in 21-day cycles until disease progression or unacceptable toxicity. Dose Expansion Phase : Dose Expansion Phase will begin at the defined MTD/RP2D for solid tumors and hematological malignancies groups, to further evaluate the safety, tolerability, and PDx profile of ATG-018. Subjects with solid tumors and hematological malignancies will be enrolled.

Timeline

• Start date: 2022-07-08
• Primary completion: 2024-01-08
• Completion: 2024-01-08
• First posted: 2022-04-21
• Last updated: 2024-07-18

Locations

5 sites across 1 country: Australia