Participant flow

Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer · Source last updated 2026-04-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

   id

   FG000

   title

   Phase I: X-396 (Ensartinib) at 25 mg

2. description

   Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

   id

   FG001

   title

   Phase I: X-396 (Ensartinib) at 50 mg

3. description

   Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

   id

   FG002

   title

   Phase I: X-396 (Ensartinib) at 100 mg

4. description

   Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

   id

   FG003

   title

   Phase I: X-396 (Ensartinib) at 200 mg

5. description

   Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

   id

   FG004

   title

   Phase I: X-396 (Ensartinib) at 225 mg

6. description

   Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

   id

   FG005

   title

   Phase I: X-396 (Ensartinib) at 250 mg

7. description

   Dose expansion starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase II: X-396 (ensartinib): Oral, ALK inhibitor

   id

   FG006

   title

   Phase II: X-396 (Ensartinib) at 225 mg

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         11

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         10

      7. group Id

         FG006

         num Subjects

         94

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         11

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         10

      7. group Id

         FG006

         num Subjects

         94

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      7. group Id

         FG006

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A total of 131 subjects were treated at 16 sites in the US, including 37 subjects in the escalation cohorts and 94 subjects in the expansion cohort.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice