Sophic Logo gordian knotThyroid Cancer Clinical Trials Intelligence

Monthly Update Report - October 2025


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Important Notice:
Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. This report is not a substitute for professional medical advice, diagnosis, or treatment.

1: Summary data from new trials identified for Thyroid Cancer.


Overview

Number of Trials: 3

These three trials address thyroid cancer and advanced solid tumors. One pilot trial evaluates a website-based intervention for managing radioactive iodine (RAI) side effects in differentiated thyroid cancer patients. A second phase I trial tests systemically administered IL13Ra2-targeted CAR T-cell therapy in metastatic melanoma and other solid tumors expressing IL13Ra2. The third is a randomized phase II trial comparing two doses of lenvatinib in symptomatic or progressive radioactive iodine-resistant differentiated thyroid cancer.

Common Criteria Across Trials

Common Inclusion

  • Age 18 years or older
  • Histologically confirmed malignancy or thyroid cancer diagnosis
  • Measurable or evaluable disease
  • ECOG performance status 0-2
  • Adequate bone marrow function (ANC ≥1.0, platelets ≥75-100, hemoglobin ≥9-9.5 g/dL)
  • Adequate hepatic function (AST/ALT ≤2.5-3x ULN, bilirubin ≤1.5-2x ULN)
  • Adequate renal function (creatinine clearance >30-45 mL/min)
  • Ability to provide informed consent
  • Use of effective contraception for women of childbearing potential and men

Common Exclusion

  • Cognitive or psychiatric conditions precluding informed consent
  • Pregnant or breastfeeding
  • Untreated or uncontrolled brain metastases
  • Uncontrolled intercurrent illness (active infection, symptomatic heart failure, unstable angina, arrhythmia)
  • HIV, hepatitis B, or hepatitis C with detectable viral load or active infection
  • Concurrent investigational agents
  • Hypersensitivity to study agents
  • Recent major surgery (within 14 days)
  • Concurrent medications causing QTc prolongation

2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT06853925

A Pilot Randomized Controlled Trial of the Use of a Website About Radioactive Iodine Symptom Management in Patients With Thyroid Cancer

Organization/Sponsor: Georgetown University


Example patient: A 45-year-old English-speaking patient with papillary thyroid cancer who received radioactive iodine treatment 18 months ago and experiences mild fatigue and dry mouth, with internet access at home.

Phase N/A

Interventions

  • Behavioral: Treatment as Usual (TAU)
    Summary: Standard thyroid cancer care involving surgery, radioactive iodine, and thyroid hormone suppression therapy without specific molecular targets. Source: Summary of Web Search.
  • Behavioral: Radioactive Iodine Support (RAI Support)
    Summary: Website-based intervention providing symptom management education for patients experiencing side effects from radioactive iodine treatment targeting thyroid cancer cells. Source: Summary of Web Search.

Key Inclusion

  • Age 18 or older
  • Diagnosed with differentiated thyroid cancer (papillary or follicular carcinoma)
  • Received radioactive iodine (RAI) treatment within three years
  • Mild to moderate symptoms of RAI
  • Able to provide informed consent in English
  • Access to computer, tablet, or smartphone with internet

Key Exclusion

  • Cognitive or psychiatric condition precluding informed consent
  • Hearing problems preventing study participation
  • Unable to complete study procedures

NCT04119024

Phase I Dose Escalation Study of Systemically Administered IL13Ra2 Chimeric Antigen Receptor (CAR) T Cells After a Nonmyeloablative Conditioning Regimen in Patients With Metastatic Melanoma and Other Solid Tumors Genomic-based

Organization/Sponsor: Stanford University


Example patient: A 52-year-old with Stage IV melanoma expressing IL13Ra2 who progressed after pembrolizumab and dabrafenib/trametinib combination therapy, ECOG 1, with controlled brain metastases and adequate organ function.

Phase 1

Interventions

  • Biological: IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells
    Summary: Genetically modified autologous T-cells targeting IL13Ralpha2-expressing tumors via a hinge-optimized CAR with 4-1BB co-stimulation and CD3-zeta signaling domains; includes CD19t marker for tracking; induces selective cytolysis of IL13Ra2-overexpressing cancer cells (NCI Thesaurus).
  • Drug: Fludarabine Phosphate
    Summary: Fluorinated nucleotide analog that inhibits DNA polymerase, ribonucleotide reductase, and DNA primase to interrupt DNA synthesis; used for lymphodepletion conditioning prior to CAR T-cell infusion (FDA label, NCI Thesaurus).
  • Drug: Cyclophosphamide
    Summary: Alkylating agent converted to active metabolites that bind DNA and inhibit replication; used for lymphodepletion conditioning to enhance CAR T-cell engraftment and expansion (FDA label, NCI Thesaurus).
  • Diagnostic: Fludeoxyglucose F-18
    Summary: Positron-emitting radiopharmaceutical glucose analog that localizes to areas of high metabolic activity; used in PET imaging to assess tumor burden and treatment response (FDA label, NCI Thesaurus).
  • Procedure: Positron Emission Tomography
    Summary: Imaging technique measuring gamma radiation from positron-electron collisions to reveal metabolic activity in tissue; used to monitor disease progression and treatment response (NCI Thesaurus).
  • Procedure: Magnetic Resonance Imaging
    Summary: Imaging using radiofrequency waves and magnetic fields to visualize tumors and assess size, location, and treatment effects without radiation exposure (NCI Thesaurus).
  • Procedure: Computed Tomography
    Summary: X-ray imaging method producing cross-sectional scans to examine internal structures and monitor disease progression (NCI Thesaurus).
  • Procedure: Biospecimen Collection
    Summary: Gathering of tissue or fluid samples for testing, research, and diagnostic purposes to study disease characteristics (NCI Thesaurus).
  • Procedure: Biopsy
    Summary: Removal of tissue specimens for microscopic examination to establish diagnosis and confirm IL13Ra2 expression (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed surgically incurable malignancy: Stage IIIC/IV melanoma or metastatic solid tumor refractory to standard therapies
  • IL13Ralpha2 tumor expression confirmed by IHC with H-Score ≥50 in ≥10% of tumor specimen
  • Age 18-75 years
  • ECOG performance status 0 or 1
  • At least one measurable lesion per RECIST or photographically documented skin lesion
  • Melanoma patients must have progressed after ≥1 line including checkpoint inhibitor and BRAF/MEK inhibitor if BRAF V600 mutated
  • Adequate organ function: ANC ≥1x10^9/L, platelets ≥75x10^9/L, hemoglobin ≥9.5 g/dL
  • Willing to undergo leukapheresis and provide informed consent

Key Exclusion

  • Clinically active brain metastases
  • Systemic cancer treatment including immunotherapy within 14 days of conditioning chemotherapy
  • Systemic corticosteroids or immunosuppressive drugs within 2 weeks
  • HIV seropositivity or acquired immune deficiency
  • Hepatitis B or C with ongoing liver damage
  • LVEF <45% or significant cardiac abnormalities
  • Tiffeneau-Pinelli index <70% predicted
  • Pregnancy or breastfeeding

NCT07092514

Randomized Phase II Trial of Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)

Organization/Sponsor: Washington University School of Medicine


Example patient: A 52-year-old with papillary thyroid cancer refractory to radioactive iodine after cumulative 650 mCi dose, showing progressive lung metastases on recent imaging, previously treated with one line of sorafenib, with ECOG status 1 and controlled blood pressure.

Phase II

Interventions

  • Drug: Lenvatinib
    Summary: Lenvatinib is an oral receptor tyrosine kinase inhibitor that blocks VEGFR2 and multiple kinase pathways involved in tumor growth and angiogenesis, FDA-approved for radioactive iodine-refractory differentiated thyroid cancer and other advanced cancers (FDA label, NCI Thesaurus).

Key Inclusion

  • Histologically confirmed papillary, follicular, or Hurthle Cell thyroid cancer
  • Incurable radioactive iodine-resistant (RAIR) differentiated thyroid cancer
  • Measurable or evaluable disease per RECIST 1.1
  • No more than 1 prior line of VEGF/VEGFR targeted therapy
  • Symptomatic or progressive disease on most recent treatment by RECIST 1.1 over last 16 months
  • At least 18 years of age
  • ECOG performance status ≤ 2
  • Blood pressure <140/90

Key Exclusion

  • Anaplastic, poorly differentiated/high-grade, and medullary thyroid cancers
  • Prior treatment with lenvatinib
  • Untreated brain metastases
  • Concurrent medications with high risk for QTc prolongation
  • Uncontrolled intercurrent illness including active infection or symptomatic heart failure
  • Pregnant or breastfeeding
  • Major surgery ≤ 14 days prior to treatment start
  • QTcF ≥ 481 msec