Ladarixin With Sotorasib in Advanced NSCLC

Conditions

• Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date

Aug 1, 2023

Status verified

Dec 2025

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Advanced NSCLC Patients
  Patients with KRASG12C mutant NSCLC will receive ladarixin and sotorasib in combination.

Primary Outcome Measure

Incidence of Dose-Limiting Toxicities (DLTs) during 1st Treatment Cycle among Phase I Participants [ Time Frame: Up to Day 21 (End Treatment Cycle 1, each cycle is 21 days) ]

Central Contacts

• Salman Punekar, MD
  212 731 6228
  [email protected]

Locations (6)

Find similar trials in Garden City, NY