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NCT06970353
Phase II Trial of Tunlametinib in NRAS-Mutant Advanced Thyroid Cancer
Phase 2 trial testing Tunlametinib in Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation in 40 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 27 May 2025 |
| Primary completion | 30 December 2026 |
| Estimated completion | 30 December 2031 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tunlametinib — full drug profile →
- Tunlametinib+PD-1 mAb — full drug profile →
Conditions studied
- Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation — all drugs for Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation →
- Advanced PDTC or ATC With NRAS Mutation — all drugs for Advanced PDTC or ATC With NRAS Mutation →
Sponsor
Fudan University
Who can join
18 and older, any sex, with Radioactive Iodine-refractory, Differentiated Thyroid Cancer With NRAS Mutation or Advanced PDTC or ATC With NRAS Mutation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Clinical management and therapeutic development for the rare disease rhabdomyosarcoma.
Ke TL, Chen L. · · 2026 · PMID 41584037 · DOI 10.7150/jca.127496
Verify or expand the search:
- PubMed search for NCT06970353
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tunlametinib
Trials testing the same drug.
- NCT07170293 — Phase II Trial of Tunlametinib in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors · Phase 2 · recruiting
Other Fudan University trials
Trials by the same sponsor.
- NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
- NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
- NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
- NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06970353 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 7 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06970353.
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