Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06359847

Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer

Led by Beijing Scitech-Mq Pharmaceuticals Limited · Updated on 2025-08-24

60

Participants Needed

1

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

ST-1898, a multi-targeted tyrosine kinase inhibitor, has demonstrated strong inhibitory activity for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT, etc. The primary purpose of this study is to evaluate the efficacy of ST-1898 tablets in patients with locally advanced or metastatic RAIR-DTC after failure of at least first-line TKI systemic therapy. All subjects will receive ST-1898 180 mg orally once daily until disease progression or intolerable toxicity.

CONDITIONS

Official Title

Study of ST-1898 in Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Life expectancy of 12 weeks or more
  • Histologically or cytologically confirmed locally advanced or metastatic differentiated thyroid cancer not removable by surgery or radiotherapy
  • At least one measurable tumor lesion according to RECIST 1.1
  • Radioiodine-refractory differentiated thyroid cancer diagnosed by specific criteria under TSH stimulation
  • Failure or intolerance to at least one prior tyrosine kinase inhibitor therapy (no more than two prior VEGFR-TKIs if applicable)
  • Availability of archived tumor tissue sample or biomarker test report; fresh biopsy optional if archived sample unavailable
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • TSH-suppression therapy tolerated with TSH less than 0.5 mU/L
  • Adequate organ and bone marrow function including specified blood counts, liver, kidney, coagulation, cardiac function, and proteinuria limits
  • Ability to understand and sign informed consent
  • Agreement to use adequate contraception during study and for 3 months after last dose; women of childbearing potential must have negative pregnancy test within 7 days before treatment start
Not Eligible

You will not qualify if you...

  • Other thyroid cancer types except differentiated thyroid cancer (e.g., anaplastic or medullary thyroid carcinoma)
  • Known allergy to any component of ST-1898 tablets
  • Antitumor treatment within 4 weeks or 5 half-lives before starting study drug
  • Major surgery, open biopsy, or significant injury within 4 weeks before treatment
  • Serious non-healing wounds, ulcers, or bone fractures
  • Grade 3 or higher bleeding episodes within 6 months or current grade 2 or higher bleeding with high risk
  • Active hemoptysis exceeding 2.5 mL per day within 2 months before treatment
  • Use of antiplatelet agents except low-dose aspirin (≤100 mg/day)
  • Severe retinopathy unsuitable for study participation
  • Significant cardiovascular diseases including arrhythmias, QTcF prolongation, recent acute coronary events, heart failure class II or higher, or uncontrolled hypertension
  • Untreated or unstable brain metastases
  • Interstitial lung disease or radiation pneumonia needing glucocorticoids
  • Malignant tumors within last 5 years except certain cured cancers
  • Use of strong CYP3A4 inducers, inhibitors, or narrow therapeutic window substrates within 2 weeks before study drug
  • Prior treatment with BRAF inhibitors
  • Unresolved toxicities from prior therapies above grade 1 (with some exceptions)
  • Positive tests for HIV, active hepatitis B or C, or other active hepatitis with significant liver disease
  • Active infections requiring systemic treatment
  • Pregnancy or breastfeeding
  • Drug or alcohol dependence
  • Significant neurological or mental disorders or poor compliance
  • Inability to take oral drugs or malabsorption conditions
  • Uncontrolled pleural, pericardial, or abdominal effusions requiring frequent intervention
  • Other serious systemic diseases or conditions interfering with study participation or results interpretation as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

Y

Yansong Lin, MD

CONTACT

X

Xin Zhang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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