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Differentiated Thyroid CancerPhase 1/2NCT05745363

Clinical Study of AL2846 Capsule in the Treatment of Differentiated Thyroid Cancer

A Phase 1/2 study testing AL2846 capsule in people with Differentiated Thyroid Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase Ib clinical trial to evaluate the efficacy and safety of AL2846 capsule in iodine-refractory differentiated thyroid cancer that has failed previous TKI treatment. The trial is planned to enroll 20 subjects. The trial is a single-arm, multi-center, open label clinical study. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Differentiated Thyroid Cancer
What is being tested?
AL2846 capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
4 sitesChina
Study dates
24 Feb 2023to 13 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18~80 years old (when signing the informed consent form), regardless of gender;
  • Differentiated thyroid carcinoma (DTC) confirmed by histopathology or cytology;
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1);
  • Disease progression occurs after receiving at least one (but not more than two) Vascular Endothelial Growth Factor Receptor (VEGFR) targeted therapy in the past;
  • Iodine refractory patients can be defined as iodine refractory if they meet one of the following conditions:
  • The lesions showed no iodine uptake on the whole body imaging after 131I treatment, and could not benefit from the follow-up 131I treatment (it must be confirmed by the endocrinologist or nuclear medicine physician. If there are too many residual thyroid, it may affect the iodine uptake of the metastatic lesions, which can be evaluated when the thyroid is removed and treated again);
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  • The lesions that originally took iodine gradually lost the ability to take iodine after 131I treatment;
  • Some lesions in the same patient take iodine, while some lesions do not take iodine, and there is no biochemical remission;
  • The focus takes iodine, but the disease progresses within 12 months (confirmed by imaging);
  • The cumulative dosage of 131I ≥ 600mCi or 22GBq, but the disease did not alleviate (confirmed by imaging).
  • There was evidence of imaging progress within 14 months before the knowledge;
  • Thyroid Stimulating Hormone (TSH) ≤ 0.5mIU/L under the treatment of TSH inhibitor;
  • Eastern Cooperative Oncology Group (ECOG) score: 0-1;
  • Estimated survival time ≥ 12 weeks;
  • Normal function of main organs
  • HBsAg positive patients must meet the requirements of Hepatitis B Virus (HBV) DNA compliance or receive anti-HBV treatment at least one week before the start of the study, and the virus index is reduced by more than 10 times. At the same time, the patients are willing to receive anti-HBV treatment throughout the whole study period; The patients with hepatitis C antibody positive and Hepatitis B Virus (HCV) RNA quantitative positive should complete antiviral treatment at least 1 month before starting the study; 12) The serum Human Chorionic Gonadotropin (HCG) test of female patients of childbearing age must be negative within 7 days before study enrollment and must be non-lactating; The patient should agree to use contraception during the study period and within 6 months after the end of the study period; 13) The patient voluntarily joined the study and signed the informed consent form, with good compliance.

Who cannot join

  • Combined with the following diseases or medical history:
  • Have undifferentiated thyroid cancer or medullary thyroid cancer;
  • Known thyroid cancer with Rearranged during Transfection (RET) fusion positive;
  • Other malignant tumors have occurred or are present at the same time within<3 years before the first administration. The following two cases can be included in the group: other malignant tumors treated by single surgery have achieved R0 resection without recurrence and metastasis; Cured cervical carcinoma in situ, skin basal cell carcinoma and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
  • CTCAE5.0 ≥ grade 2 therapeutic toxicity caused by any previous treatment that has not been completely relieved, excluding hair loss;
  • Inability to tolerate multiple factors affecting oral medication due to any reason;
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  • Major surgical treatment or obvious traumatic injury (excluding puncture for diagnosis, endoscopic biopsy, etc.) was received within 4 weeks before the first administration;
  • Wounds or fractures that have not been cured for a long time;
  • Arterial/venous thrombosis events occurred within 6 months before the first administration, such as cerebrovascular accident, deep venous thrombosis and pulmonary embolism;
  • Those who have a history of abuse of psychotropic substances and are unable to quit or have mental disorders;
  • Subjects with any severe and/or uncontrollable disease, including:
  • Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
  • Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia (including male corrected QT interval ≥ 450ms, female corrected QT interval ≥ 470ms) and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification);
  • Active or uncontrolled serious infection (≥ CTCAE grade 2);
  • Decompensated stage of liver cirrhosis;
  • Renal failure requiring hemodialysis or peritoneal dialysis;
  • Have a history of immunodeficiency, including HIV-positive or other acquired and congenital immunodeficiency diseases, have received allogeneic hematopoietic stem cell transplantation, solid organ transplantation or have received autologous hematopoietic stem cell transplantation within 12 weeks before the first administration;
  • Poor control of diabetes (FBG>10mmol/L);
  • Those who have epilepsy and need treatment;
  • Tumor related symptoms and treatment:
  • Have received surgery, chemotherapy, radiotherapy (brain radiotherapy for 2 weeks) or other anti-cancer therapy within 4 weeks before the first administration;
  • Participated in clinical trials of other anti-tumor drugs within 4 weeks before the first administration;
  • Any type of small-molecule kinase inhibitor has been accepted within 2 weeks before the first administration;
  • Within 2 weeks before the first administration, he has received the treatment of traditional Chinese medicine with anti-tumor indications specified in the drug instructions approved by China National Medical Products Administration;
  • Uncontrolled pleural effusion, pericardial effusion or ascites that still need repeated drainage (judged by the investigators);
  • Others:
  • Vaccination history of live attenuated vaccine within 4 weeks before the first administration or live attenuated vaccine is planned during the study period;
  • Allergic to known ingredients of AL2846 capsule;
  • According to the judgment of the researcher, there are patients with concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or those who think there are other reasons that are not suitable for inclusion.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Affiliated Hospital Of Guilin Medical University

    Guilin, Guangxi, 541001

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650011

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

Other trials in China

About this study

Official title: Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of AL2846 Capsule in Iodine-resistant Differentiated Thyroid Cancer With Previous TKI Treatment Failure

This is a Phase Ib clinical trial to evaluate the efficacy and safety of AL2846 capsule in iodine-refractory differentiated thyroid cancer that has failed previous TKI treatment. The trial is planned to enroll 20 subjects. The trial is a single-arm, multi-center, open label clinical study. Objective response rate (ORR) is the primary endpoint.

Being tested
AL2846 capsule

What participants receive

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

  • AL2846 capsuleDrug

    AL2846 is a multi-target tyrosine kinase inhibitor

Study groups in NCT05745363
Study groupRoleWhat they receive
AL2846 capsuleExperimentalAL2846 capsules monotherapy, 28 days as a treatment cycle.
Receives: Drug: AL2846 capsule

What is being measured

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

  1. Objective remission rate (ORR)

    ORR is defined as the percentage of participants with complete remission (CR) and partial remission (PR) based on investigator records.

    Measured: From baseline up to 12 months.

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    PFS is defined as the time from randomization to the first recorded progressive disease (PD) or death from any cause.

    Measured: From baseline up to 12 months.

  2. Disease control rate (DCR)

    DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease.

    Measured: From baseline up to 12 months.

  3. Duration of remission (DoR)

    The time from the start of the first evaluation of the tumor as CR or PR to the first assessment as PD or death from any cause.

    Measured: From baseline up to 12 months.

  4. Overall survival (OS)

    Time from the first administration to death due to any cause.

    Measured: From baseline to death event.

  5. Occurrence of all adverse events (AEs)

    Adverse events are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

    Measured: From baseline to 28 days after the last dose or start of a new antineoplastic therapy (whichever comes first).

Timeline

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

  1. First posted27 Feb 2023
  2. Study start24 Feb 2023
  3. Primary completion13 Nov 2025
  4. Study completion13 Nov 2025

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05745363
Sponsor's protocol ID
AL2846-Ib-02
Status last verified
Nov 2025
First submitted
16 Feb 2023
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AL2846 capsule in people with Differentiated Thyroid Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 4 sites 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 16 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: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective remission rate (ORR) (time frame: From baseline up to 12 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 NCT05745363.

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 16 Dec 2025.

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