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

Recruiting now · Phase 2

Conditions studied: Differentiated Thyroid Carcinoma

In brief

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.

Key facts

Study ID: NCT06359847
Run by: Beijing Scitech-Mq Pharmaceuticals Limited
People needed: 60
Starts: 2023-11-15
Expected to finish: 2027-12-01
Last updated by the study team: 2025-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Other histological subtypes of thyroid cancers excluding DTC (such as Anaplastic Thyroid Carcinoma and Medullary Thyroid Carcinoma).
Known hypersensitivity to any component of ST-1898 tablets.
Participants who have received any antitumor treatment within 4 weeks or 5 half-lives of the agent (contingent on the shorter time) prior to the first dose of study drug.
Patients who underwent major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of study drug.
Serious non-healing wound/ulcer/bone fracture.
≥ grade 3 bleeding episodes within 6 months prior to first dose of study treatment, or currently ≥ grade 2 hemorrhage, with high bleeding risks (such as coagulation disorders, tracheobronchial infiltration with significant bleeding, active gastrointestinal ulcer and esophageal varices)
Active hemoptysis or more than 0.5 teaspoon (2.5 mL) of hemoptysis per day within 2 months before first dose of study treatment
Subjects with antiplatelet agents treatment (low-dose aspirin ≤100 mg/day is permitted).
Current or previous severe retinopathy who, in the judgment of the Investigator or specialist, are not suitable for enrollment
Significant cardiovascular impairment, including but not limited to:
Serious arrhythmia or cardiac conduct abnormality, such as degree II-III atrioventricular block or ventricular arrhythmia needs to be treated.
QTcF interval extension (by the Fridericia formula): male >450 ms, female >480 ms
Acute coronary syndrome, stroke, deep vein thrombosis, pulmonary- thromboembolism, arterial thrombosis, congestive heart failure, aortic dissection etc.
New York Heart Association Class ≥ II
Uncontrolled hypertension, as defined by a sustained blood pressure (BP) > 140/90 mmHg.
Known brain metastasis unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and with a stable dose of corticosteroid treatment before first dose of study treatment.
Interstitial lung disease or radiation pneumonia in need of glucocorticoids intervention
Subjects with malignant tumors in the last 5 years (not including non-melanoma skin cancer, breast cancer or cervical cancer in situ, and Non-Muscle-invasive bladder cancer have been cured)
Receiving chronic concomitant treatment of strong CYP3A4 inducers, CYP3A4 inhibitors or CYP3A4 substrate with a narrow therapeutic window within 2 weeks prior to study drug administration,
Prior treatment of BRAF inhibitors.
Has not recovered from toxicities caused by prior therapy to CTCAE ≤Grade 1 (except for ≤Grade 2 peripheral neuropathy, alopecia, and other events judged tolerable by the Investigator and without safety risks).
HIV antibodies or Treponema pallidum antibodies positive, active hepatitis B (HBV-DNA≤ 2×ULN allowed to enroll), hepatitis C virus (HCV) antibody-positive and HCV-RNA- positive, or other active hepatitis, clinically significant moderate-to-severe cirrhosis. Prophylactic antiviral therapy other than interferon are allowed.
Acute bacterial, viral or fungal infections (any infection requiring systemic treatment)
Females who are pregnant or breastfeeding.
Drug or alcohol dependents.

Where it is running

Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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