Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer

• Status: RECRUITING
• Trial end date: 2031-12-30

Summary

This phase II trial evaluates Tunlametinib (MEK inhibitor) PD-1 in NRAS-mutant advanced thyroid cancer.

Key Objectives:

Assess efficacy (ORR by RECIST v1.1) Evaluate safety profiles

Study Design:

Single-arm, single-center 4 cohorts based on:

• Histology (differentiated vs. poorly/undifferentiated)
• Prior therapy status

Treatment:

• Cohorts 1-2: Tunlametinib monotherapy (12mg BID)
• Cohorts 3-4: Tunlametinib + PD-1 (commercially available)

Key Procedures:

Screening: NRAS testing + full staging (CT/MRI/PET) Monitoring: q3-week labs, q9-week imaging Follow-up: 30-day safety visit + q3-month survival tracking

Endpoints:

Primary: ORR Secondary: Safety (CTCAE), PFS, DoR

Unique Aspects:

First study targeting NRAS in thyroid cancer with MEK+PD-1 Includes rare aggressive subtypes (poorly/undifferentiated)

• Phase: PHASE2

Details

• Lead Sponsor: Fudan University