Phase I/II Study of Ladarixin and Sotorasib in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)

Summary

This is a phase I/II, open-label, study of twice-daily oral ladarixin with sotorasib in participants with advanced KRASG12C mutant non-small cell lung cancer (NSCLC).

Description

Eligibility

Age range

18–100 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Sotorasib

  Sotorasib administered at the approved dose of 960mg PO once daily over 21-day treatment cycles.

• Drug
  Ladarixin

  Ladarixin dose will be escalated as follows in Phase I: 3 patients will receive a starting dose of 200mg. If 2 or more patients experience a DLT at the lowest dose, the study will stop. If 0 out of 3 patients experience a DLT within 28 days, the next 3 patients will receive 300mg. If 1 out of 3 patients experiences a DLT, 3 more patients will be added to the 200 mg dose. If no more patients experience a DLT at 200mg, the next 3 patients will receive 300mg. If 2 of 6 patients receiving 200mg experience a DLT, the study will stop. If 2 or more patients experience DLTs, the maximum tolerated dose (MTD) will be the previous dose level. The same process will be repeated at each dose level. There will be 6 patients enrolled at MTD level for a maximum of 12 patients in the phase I cohort. Ladarixin will be administered as a twice-daily dose over a 21 day treatment cycle. In Phase II, ladarixin will be administered twice-daily at the recommended phase II dose over 21-day cycles.

Locations (6)