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

NCT06359847 | Recruiting Phase 2

• 1 other identifier: ST-1898-202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Differentiated Thyroid Carcinoma

Keywords

ST-1898，Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the proportion of patients who have had a PR or CR as assessed by the RECIST 1.1. (CR: Complete Response, Disappearance of all target lesions, PR: Partial Response, \>=30% decrease in the sum of the longest diameters of target lesions). Overall Response (OR) = CR + PR

  Up to 24 months

Secondary Outcomes (12)

• The number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs)

  Up to 24 months

• PFS

  Up to 24 months

• PFS6m

  up to 24 months

• DCR

  up to 24 months

• DOR

  up to 24 months

Study Arms (1)

ST-1898

EXPERIMENTAL

ST-1898 tablet is administered orally at 180 mg once daily in 21-day cycles (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21), until disease progression or intolerable toxicity.

Drug: ST-1898 tablets

Interventions

ST-1898 tablets DRUG

Tablets: 5 mg and 40 mg

ST-1898

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Life expectancy of twelve weeks or more
• Histologically or cytologically confirmed locally advanced or metastatic DTC that cannot be removed by surgery or radiotherapy, including papillary thyroid cancer, follicular thyroid cancer, hurthle cell thyroid cancer or poorly differentiated thyroid cancer.
• At least one measurable lesion according to RECIST 1.1
• Radioiodine-refractory (RAI-refractory) differentiated thyroid cancer can be diagnosed when any of the following criteria are met under thyroid-stimulating hormone (TSH) stimulation (\>30 mU/L) in the absence of exogenous iodine interference:
• Negative uptake in one or more measurable lesions after receiving I-131 treatment or scanning
• One or more measurable lesions that has progressed as per RECIST 1.1 within 14 months of 131I therapy（3.7\~7.4 GBq or100\~200 mCi）,despite demonstration of radioiodine avidity at the time of that treatment by pre- or post-treatment scanning.
• Cumulative activity of 131I of \> 22 GBq or 600 mCi, with the last dose administered at least 6 months prior to study entry
• Subjects with DTC who failed with or was intolerant to at least one prior tyrosine kinase inhibitor (TKI) therapy. If prior treatment with VEGFR-TKI, no more than two VEGFR-TKIs were allowed.
• Recommendation of subject offering archived tissue sample or previous biomarker of MET test report. If archived tumor sample is not available, a fresh biopsy is optional, which need to be taken from needle biopsy or core needle biopsy (fine needle biopsy not allowed). Subjects who cannot provide tissue samples or test reports may still be eligible to participate if the investigator determines a potential clinical benefit from ST-1898 therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• TSH-suppression therapy is well tolerated with thyroid stimulating hormone (TSH) \< 0.5 mU/L;
• The patient has adequate organ and bone marrow function as follows:
• Adequate bone marrow function (without transfusion or colony stimulating factor support within 2 weeks): hemoglobin ≥ 90 g/L, absolute neutrophil count (ANC) ≥ 1.5 ×10\^9/L and platelets ≥ 100 × 10\^9/L;
• Adequate liver function: Bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5 × ULN if participant has liver metastases);

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.

Sponsors & Collaborators

• Beijing Scitech-Mq Pharmaceuticals Limited: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

3-(3'-adamantan-1-yl-4'-methoxybiphenyl-4-yl)-2-propenoic acid

Study Officials

• Yansong Lin, Ph D

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yansong Lin, MD

CONTACT

0086-10-69151188; linyansong1968@163.com

Xin Zhang, MD

CONTACT

0086-10-69151188; zhangxin37@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: April 11, 2024
• Study Start: November 15, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)