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

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

Trial Details

NCT ID
NCT06970353
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Thyroid Cancer
Interventions
  • Tunlametinib
  • Tunlametinib+PD-1 mAb
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Patients voluntarily join this study and sign an informed consent form;
  • Age: ≥ 18 years old, male or female not limited;
  • For locally advanced or recurrent/metastatic thyroid cancer diagnosed by histology and unable to undergo curative surgery, one of the following req…
  • Iodine refractory thyroid cancer;

For full eligibility, visit ClinicalTrials.gov.

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