About this trial

An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.

Eligibility criteria

Qualifiers

Part A: No gender limitation. Patients with histologically and/or cytologically confirmed ALK/ROS1 gene fusion positive non-small cell lung cancer and various advanced tumors.

At least one measurable tumor lesion.

ECOG score is 0~1.

Life expectancy of ≥3 months.

Disqualifiers

Undergone major surgery or major trauma within 28 days before first dose or a diagnostic biopsy within 14 days before first dose.

Received systemic antitumor drugs, including investigational drugs.

Received radiotherapy within 14 days before first dose.

Previous treatment with FAK inhibitors.

Trial design

Treatments tested in this trial

  • APG -2449
  • PLD

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

1
Sun Yat-sen University Cancer Center510060, GuangzhouGuangdong, China

Sponsors and collaborators

Ascentage Pharma Group Inc.

Lead sponsor