RecruitingPhase IIEN originalOther cancers

MRG003 Added to Ongoing Treatment After Progression in EGFR-Positive Advanced Thyroid Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This study will evaluate whether adding MRG003 to an ongoing treatment regimen can produce confirmed tumor shrinkage in patients with EGFR-positive advanced thyroid cancer whose cancer initially benefited from that regimen and later progressed. The study will also evaluate the safety of the combinations. Cohort A will include patients with anaplastic or poorly differentiated thyroid carcinoma who previously benefited from lenvatinib plus an anti-PD-1 inhibitor and subsequently progressed. They will continue lenvatinib and the same anti-PD-1 inhibitor, with MRG003 added. Cohort B will include patients with radioactive iodine-refractory differentiated thyroid carcinoma who previously benefited from lenvatinib and subsequently progressed. They will continue lenvatinib, with MRG003 added. MRG003 will be given intravenously at 2.0 mg/kg every 3 weeks. The study plans to enroll 39 participants: 24 in Cohort A and 15 in Cohort B. The first 3 participants in each cohort will undergo an initial 6-week safety assessment before further enrollment is allowed. If additional safety assessment is needed, up to 6 participants who can be evaluated for dose-limiting toxicity will be assessed within the planned cohort enrollment. The main outcome is the proportion of patients in each cohort whose tumors shrink or disappear within 12 weeks after MRG003 starts, with the response confirmed at least 4 weeks later and by Week 18. Scans obtained before MRG003 is added provide the new baseline. Disease control is assessed at Week 12. Other response and survival outcomes are followed for up to 12 months after MRG003 starts. Safety follow-up continues during study treatment and for 90 days after the last study treatment dose, with longer follow-up of unresolved events as needed.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek 18-80 lat
  • •Potwierdzony zaawansowany rak tarczycy (typ anaplastyczny, słabo zróżnicowany lub oporny na jod radioaktywny)
  • •Guz z dodatnim markerem EGFR
  • •Wcześniejsza pozytywna odpowiedź na lenvatinib (z inhibitorem PD-1 lub bez), a następnie wznowienie choroby
  • •Możliwość kontynuowania poprzedniego leczenia
  • •Stan ogólny pacjenta 0 lub 1 (potrafi pracować lub wykonywać lekkie czynności)
  • •Spodziewana długość życia co najmniej 3 miesiące
  • •Wyniki badań krwi w normie (wystarczająca liczba białych krwinek, płytek, dobra funkcja nerek i wątroby)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
80 Years
Last updated (source)
October 14, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/15/2026.

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