MedTrace Logo

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

NCT06970353 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-07

No results posted yet for this study

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)

Conditions

  • Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation
  • Advanced PDTC or ATC With NRAS Mutation

Interventions

DRUG

Tunlametinib

Locally advanced or metastatic radioactive iodine refractory NRAS mutant differentiated thyroid cancer

DRUG

Tunlametinib+PD-1 mAb

Locally advanced or metastatic NRAS mutant poor-differentiated, undifferentiated thyroid cancer

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Yu-Long Wang, M.D · Fudan University

  • Qing-Hai Ji, M.D · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-27
Primary Completion
2026-12-30
Completion
2031-12-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06970353 on ClinicalTrials.gov