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New treatment option for Thyroid Cancer
Official title MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC
ClinicalTrials.gov ID: NCT07235566
What this study is testing
What is MRG003 in combination with pucotenlimab?
MRG003 in combination with pucotenlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for thyroid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-arm, open-label, multi-cohort, single-center phase II clinical trial designed to observe and evaluate the efficacy and safety of MRG003 (a EGFR-ADC) in combination with pucotenlimab (a PD-1 inhibitor) for the treatment of EGFR-positive unresectable recurrent or metastatic ATC/PDTC. All patients will receive the combination therapy every three weeks until disease progression or other event as defined in the protocol occurs.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Age ≥18 years on the day of signing the informed consent form, regardless of gender.
- Expected survival time ≥12 weeks.
- Patients with pathologically confirmed EGFR-positive ATC or PDTC, currently in a recurrent or metastatic stage and not eligible for curative...
- For people with either BRAF V600E wild-type or mutant-type, treatment-naive patients or those who have previously received targeted therapy ±...
You likely can't join if
- Medullary thyroid carcinoma or other malignancies not originating from thyroid follicular cells;
- History of other primary malignancies; Except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin...
- Received any of the following treatments:
- Prior treatment with an ADC drug;
- Treatment with an investigational drug from another clinical trial within 28 days prior to the first dose (excluding already marketed drugs);
- Treatment with anti-tumor Chinese patent medicines or herbal medicines within 14 days prior to the first dose;
See the full eligibility criteria
Who can join
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Age ≥18 years on the day of signing the informed consent form, regardless of gender.
- Expected survival time ≥12 weeks.
- Patients with pathologically confirmed EGFR-positive ATC or PDTC, currently in a recurrent or metastatic stage and not eligible for curative resection. ATC/PDTC may coexist with differentiated thyroid cancer. EGFR...
- For people with either BRAF V600E wild-type or mutant-type, treatment-naive patients or those who have previously received targeted therapy ± immunotherapy are eligible for enrollment. Regarding neoadjuvant/adjuvant...
- people must be able to provide tumor tissue specimens (paraffin blocks, paraffin-embedded sections, or fresh tissue sections) from primary or metastatic sites for pathological testing. The most recent archived tumor...
- There must be radiographic evidence of disease progression during or after the most recent treatment, confirmed by the investigator. According to RECIST 1.1 criteria, there must be at least one measurable extracranial...
- Adverse events related to prior anti-tumor treatment have recovered to ≤ Grade 1 according to NCI CTCAE v5.0 (except for alopecia, non-clinically significant or asymptomatic laboratory abnormalities).
- ECOG performance status of 0 or 1 within 7 days prior to treatment.
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to treatment.
- Organ function levels must meet the following requirements within 7 days prior to treatment.
- Fertile male and female people of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of the study drug. Women of...
What rules you out
- Medullary thyroid carcinoma or other malignancies not originating from thyroid follicular cells;
- History of other primary malignancies; Except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; or patients who have received...
- Received any of the following treatments:
- Prior treatment with an ADC drug;
- Treatment with an investigational drug from another clinical trial within 28 days prior to the first dose (excluding already marketed drugs);
- Treatment with anti-tumor Chinese patent medicines or herbal medicines within 14 days prior to the first dose;
- Radiotherapy within 28 days prior to the first dose, or palliative radiotherapy for bone metastases within 2 weeks prior to the first dose;
- Major surgery within 28 days prior to the first dose without full recovery, or planned major surgery within the first 12 weeks after receiving the study drug.
- Untreated or unstable brain parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis, or leptomeningeal metastases; Note: Patients who have received local brain therapy may be enrolled if...
- Presence of third-space fluid that cannot be controlled by methods such as drainage (e.g., massive ascites, pleural effusion, pericardial effusion, etc.), or people who required drainage to control third-space fluid...
- Any severe or uncontrolled systemic disease, in the investigator's judgment, including poorly controlled hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg), poorly controlled...
- Poorly controlled cardiac disease, including heart failure of NYHA class II or above, unstable angina, myocardial infarction within the past year, clinically significant supraventricular or ventricular arrhythmia...
- Evidence of active infection, including hepatitis B (requiring both HBsAg positivity and HBV DNA ≥2000 IU/ml, excluding hepatitis due to drugs or other causes), hepatitis C (requiring both anti-HCV antibody positivity...
- History of allergy to any component of pucotenlimab or MRG003 (histidine, histidine hydrochloride, sucrose, mannitol, and polysorbate 80), or history of ≥ Grade 3 allergy to macromolecular protein...
- History of primary immunodeficiency or active autoimmune disease, currently using immunosuppressants or systemic hormonal therapy (at a dose ≥10 mg/day of prednisone or equivalent), and continuing use within 2 weeks...
- Positive serum pregnancy test or lactating women who are unwilling to use adequate contraception during the study and for 6 months after the end of study drug treatment;
- Any other situation considered by the investigator as unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.