Phase 2 Thyroid Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older who are willing to sign a consent form and follow the study's requirements.
• People with a life expectancy of at least 12 weeks.
• People who have been diagnosed through laboratory testing with a specific type of thyroid cancer called anaplastic thyroid carcinoma (ATC) or poorly differentiated thyroid carcinoma (PDTC), where more than 10% of the cancer cells test positive for a protein called EGFR, and where the cancer has come back or spread and cannot be fully removed by surgery.
• People whose cancer may or may not carry a gene change called BRAF V600E — both are eligible — and who are either new to treatment or have previously received targeted therapy with or without immunotherapy.
• People who can provide a tumour tissue sample (either stored or newly collected) for laboratory testing.
• People whose cancer can be shown on imaging scans to have grown or spread during or after their most recent treatment, and who have at least one measurable tumour outside the brain.
• People whose side effects from previous cancer treatments have mostly resolved to a mild level or better.
• People in reasonably good physical condition, as measured by a standard medical scoring system called ECOG, with a score of 0 or 1 within 7 days before starting treatment.
• People with adequate heart function, with the heart pumping at least 50% of its normal capacity, confirmed within 28 days before treatment.
• People with adequate organ function (such as liver, kidneys, and blood counts) confirmed within 7 days before starting treatment (confirm with trial site for specific levels required).
• People who are able and willing to use effective contraception from the time of signing the consent form until 6 months after the last dose; women of childbearing potential must also have a negative pregnancy blood test within 7 days before the first dose.

Who may not be able to join:

• People with a type of thyroid cancer called medullary thyroid carcinoma, or cancers that did not start in thyroid follicular cells.
• People who have had another type of cancer in the past, unless it was certain limited skin cancers or early-stage cervical cancer, or unless they received curative treatment and have had no recurrence for at least 5 years.
• People who have previously been treated with a type of drug called an antibody-drug conjugate (ADC).
• People who have taken an experimental drug from another clinical trial within 28 days before the first dose.
• People who have used certain traditional herbal or Chinese patent medicines for cancer within 14 days before the first dose.
• People who have had radiotherapy within 28 days before the first dose, or targeted radiation to bone metastases within 2 weeks before the first dose.
• People who have had major surgery within 28 days before the first dose and have not fully recovered, or who have major surgery planned within the first 12 weeks of the study.
• People with brain or spinal cord metastases that have not been treated or are not stable; people whose brain metastases have been treated may be considered if scans show stability for at least 28 days before the first dose, with no brain swelling and no need for steroid medication.
• People with uncontrolled fluid build-up in body cavities (such as the abdomen, chest, or around the heart) that cannot be managed, or who needed draining of such fluid within 14 days before dosing.
• People with serious uncontrolled health conditions, such as high blood pressure that is not well controlled (above 160/100 mmHg), poorly controlled diabetes, or signs of active bleeding.
• People with significant heart problems, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, serious heart rhythm problems requiring treatment, or abnormal heart electrical readings above certain levels.
• People with active infections including active hepatitis B or C (meeting specific laboratory thresholds), HIV, or other serious uncontrolled infections that have not been treated and resolved before starting the study drug.
• People with a known allergy to any ingredient in the study drugs (pucotenlimab or MRG003), or a history of a severe allergic reaction (Grade 3 or higher) to similar types of biological medicines.
• People with a history of a primary immune system disorder, or an active autoimmune disease, or those currently taking immune-suppressing medications or corticosteroids at a dose equivalent to 10 mg or more of prednisone per day within 2 weeks before enrolment.
• People who are pregnant, have a positive pregnancy test, or are breastfeeding and are unwilling to use adequate contraception during the study and for 6 months after the last dose.
• People whom the trial doctor considers unsuitable for participation for any other reason.

Important: Always verify eligibility with the trial site directly before applying.