OncoMatch/Clinical Trials/NCT07874321
MRG003 Added to Ongoing Treatment After Progression in EGFR-Positive Advanced Thyroid Cancer
Official title: A Prospective, Open-Label, Single-Center, Multi-Cohort Phase II Study of Becotatug Vedotin (MRG003) Added to Ongoing Lenvatinib With or Without an Anti-PD-1 Antibody After Progression Following Prior Clinical Benefit in EGFR-Positive Advanced Thyroid Cancer
Is NCT07874321 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Anti-PD-1 Inhibitor (Continuation of Prior Treatment) and Becotatug Vedotin (MRG003) for thyroid cancer.
Treatment: Becotatug Vedotin (MRG003) · Lenvatinib · Anti-PD-1 Inhibitor (Continuation of Prior Treatment) — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Thyroid Gland Carcinoma
Biomarker criteria
Required: EGFR expression (testing required; no eligibility threshold specified)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: lenvatinib (lenvatinib) — ongoing regimen (with or without anti-PD-1 inhibitor, depending on cohort)
Documented prior clinical benefit (complete response, partial response, or sustained stable disease) followed by RECIST 1.1 disease progression on the relevant ongoing regimen: lenvatinib plus an anti-PD-1 inhibitor for Cohort A, or lenvatinib for Cohort B. Continuing the prior regimen must remain clinically appropriate and tolerable. Cohort A must continue the same anti-PD-1 inhibitor
Cannot have received: antibody-drug conjugate with MMAE payload
Prior treatment with an antibody-drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload
Lab requirements
Blood counts
hemoglobin ≥ 90 g/L; WBC ≥ LLN; ANC ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L
Kidney function
serum creatinine ≤ 1.5 × ULN; creatinine clearance rate ≥ 55 mL/min
Liver function
total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN
Laboratory test results meeting the following criteria: (1) Bone marrow function: hemoglobin (Hb) ≥ 90 g/L; white blood cell count (WBC) ≥ lower limit of normal (LLN); absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L. (2) Renal function: serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); creatinine clearance rate (Ccr) ≥ 55 mL/min. (3) Liver function: total bilirubin ≤ 1.5 × ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN. (4) Coagulation function: international normalized ratio (INR) for prothrombin time ≤ 1.5 × ULN, and activated partial thromboplastin time (aPTT) within the normal range
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07874321 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-drug conjugate with MMAE payload disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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