A Phase I Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.

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

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Criteria

Inclusion Criteria:

1. Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib

2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2. (see Appendix A)

3. Life expectancy of at least 12 weeks.

4. Ability to swallow and retain oral medication.

5. Adequate organ system function, defined as follows:

1. Absolute neutrophil count (ANC) ≥1.5 x 109/L

2. Platelets ≥75 x 109/L

3. Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level

4. Total bilirubin ≤1.5 times the upper limit of normal (ULN)

5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)

≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.

6. Creatinine 1.5 x ULN.

6. Brain metastases allowed if asymptomatic at study baseline.

7. Patients must have measurable disease per RECIST v. 1.1.

Exclusion Criteria:

1. chemotherapy, radiation therapy, immunotherapy within 4 weeks.

2. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.

3. uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.