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Differentiated Thyroid CarcinomaPhase 2NCT06359847

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

A Phase 2 study testing ST-1898 tablets in people with Differentiated Thyroid Carcinoma, run by Beijing Scitech-Mq Pharmaceuticals Limited at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Differentiated Thyroid Carcinoma
What is being tested?
ST-1898 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
15 Nov 2023to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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)
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  • 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.
  • Significant disorder of neurology or mental disease or poorly compliance.
  • Subjects with oral administration impossible, or in the conditions of malabsorption as determined by the investigator, such as dysphagia and intestinal obstruction, etc..
  • Uncontrolled pleural effusion, pericardial effusion, abdominal effusion requiring frequent drainage or medical intervention (clinically significant recurrence requiring additional intervention within 2 weeks after intervention, excluding exudate cytology) before first dose of study treatment.
  • Any history of other serious systemic diseases, or any other reason that might interfere with participation in trial or interfere with interpretation of trial results, in the judgement of the Investigator, that are not qualified to participate in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yansong Lin, MD contact

0086-10-69151188

linyansong1968@163.com

Xin Zhang, MD contact

0086-10-69151188

zhangxin37@pumch.cn

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Yansong Lin, MD

    Xin Zhang, MD

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Phase II Clinical Trial to Evaluate the Efficacy and Safety of ST-1898 Tablets in Patients With Locally Advanced or Metastatic RAIR-DTC After Failure of at Least First-line TKI Systemic Therapy

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.

Being tested
ST-1898 tablets
Keywords
ST-1898，Differentiated Thyroid Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ST-1898 tabletsDrug

    Tablets: 5 mg and 40 mg

Study groups in NCT06359847
Study groupRoleWhat they receive
ST-1898ExperimentalST-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.
Receives: Drug: ST-1898 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 24 months

Secondary outcomes (12)

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

    AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.

    Measured: Up to 24 months

  2. PFS

    Progression-Free Survival (PFS) per RECIST 1.1

    Measured: Up to 24 months

  3. PFS6m

    PFS6m per RECIST 1.1

    Measured: up to 24 months

  4. DCR

    Disease Control Rate (DCR) per RECIST 1.1

    Measured: up to 24 months

  5. DOR

    Duration of Response (DOR) per RECIST 1.1

    Measured: up to 24 months

  6. OS

    Overall Survival (OS) per RECIST 1.1

    Measured: up to 24 months

  7. Thyroglobulin (Tg)

    Correlation analysis between Tg and efficacy of ST-1898

    Measured: Up to 24 months

  8. Thyroglobulin Antibody (TgAb)

    Correlation analysis between TgAb and efficacy of ST-1898

    Measured: Up to 24 months

  9. Pharmacokinetic (PK) Parameter: Tmax

    Time to Peak Plasma Concentration.

    Measured: On Day 1 from Cycle 1 to Cycle 4 (21 days per cycle), up to 12 weeks

  10. Pharmacokinetic (PK) Parameter: T1/2

    Terminal Elimination Half-life.

    Measured: On Day 1 from Cycle 1 to Cycle 4 (21 days per cycle), up to 12 weeks

  11. Pharmacokinetic (PK) Parameter: Cmax

    Maximum Plasma Concentration.

    Measured: On Day 1 from Cycle 1 to Cycle 4 (21 days per cycle), up to 12 weeks

  12. Pharmacokinetic (PK) Parameter: AUC

    Area Under the Curve of ST-1898 plasma concentration-time curve.

    Measured: On Day 1 from Cycle 1 to Cycle 4 (21 days per cycle), up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2024
  2. Study start15 Nov 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06359847
Sponsor's protocol ID
ST-1898-202
Status last verified
Oct 2026
First submitted
3 Jan 2024
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ST-1898 tablets in people with Differentiated Thyroid Carcinoma, run by Beijing Scitech-Mq Pharmaceuticals Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yansong Lin, MD (0086-10-69151188, linyansong1968@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06359847.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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