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

NCT05745363 | Completed Phase 1

• 1 other identifier: AL2846-Ib-02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 4

Brief 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. Objective response rate (ORR) is the primary endpoint.

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (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.

  From baseline up to 12 months.

Secondary Outcomes (5)

• Progression-free survival (PFS)

  From baseline up to 12 months.

• Disease control rate (DCR)

  From baseline up to 12 months.

• Duration of remission (DoR)

  From baseline up to 12 months.

• Overall survival (OS)

  From baseline to death event.

• Occurrence of all adverse events (AEs)

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

Study Arms (1)

AL2846 capsule

EXPERIMENTAL

AL2846 capsules monotherapy, 28 days as a treatment cycle.

Drug: AL2846 capsule

Interventions

AL2846 capsule DRUG

AL2846 is a multi-target tyrosine kinase inhibitor

AL2846 capsule

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (4)

Affiliated Hospital Of Guilin Medical University

Guilin, Guangxi, 541001, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, 650011, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: February 24, 2023
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-11

Locations

CN (4)