A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AL2846 to see if it can help people with advanced thyroid cancer that doesn’t respond to iodine treatment. Specifically, the trial will compare AL2846 to a placebo, which is an inactive treatment, to find out if AL2846 can help patients live longer without their cancer getting worse. The trial is for adults between the ages of 18 and 75 who have been diagnosed with a specific type of thyroid cancer and have not had success with previous treatments targeting the same cancer pathways.

To participate, individuals need to have measurable cancer that has not responded to iodine therapy and meet certain health criteria. Participants will be closely monitored throughout the study, and they’ll need to agree to use contraception if they are of childbearing age. It’s important to note that the trial is not yet recruiting participants, but it aims to help improve treatment options for those facing advanced thyroid cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants voluntarily join the study, sign the informed consent form, and demonstrate good compliance.
• • Histologically or cytologically confirmed locally advanced or metastatic differentiated thyroid carcinoma (DTC).
• • Age: 18 years ≤ age \<75 years (calculated based on the date of signing the informed consent form).
• • Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1.
• • Anticipated survival \>12 weeks.
• • At least one measurable lesion confirmed by RECIST 1.1 criteria.
• • Disease progression (per RECIST 1.1) after receiving \*\*1 or 2 prior lines of Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy
• * Confirmed iodine-refractory status, defined by \*\*one or more\*\* of the following:
• • 1. Lesions show no iodine uptake on post-Iodine-131 therapy whole-body scan and are unlikely to benefit from further Iodine-131 therapy.
• • 2. Previously iodine-avid lesions progressively lose iodine uptake after Iodine-131 therapy.
• • 3. Mixed iodine-avid and non-iodine-avid lesions in the same patient with no biochemical response.
• • 4. Iodine-avid lesions with disease progression (radiologically confirmed) within 12 months.
• • 5. Cumulative Iodine-131 dose ≥600 mCi (22 GBq) with no disease response (radiologically confirmed).
• • Thyroid stimulating hormone (TSH) ≤0.5 mIU/L under TSH-suppressive therapy.
• * Laboratory parameters meeting the following criteria:
• • 1. Hemoglobin (HGB) ≥90 g/L.
• • 2. Absolute neutrophil count (NEUT) ≥1.5×10⁹/L.
• • 3. Platelet count (PLT) ≥90×10⁹/L.
• • 4. Total bilirubin (TBIL) ≤1.5×ULN.
• • 5. Alanine aminotransferase (ALT) and Aspartate transferase (AST) ≤2.5×ULN.
• • 6. Creatinine clearance (CCR) ≥50 mL/min.
• • 7. Prothrombin time (PT), Activated partial thromboplastin time (APTT), and International Normalized Ratio (INR) ≤1.5×ULN (without anticoagulation therapy).
• • 8. Serum albumin (ALB) ≥30 g/L (no albumin infusion within 7 days prior to screening).
• • For participants of childbearing potential: Agreement to use effective contraception during the study and for 6 months after study completion. Females must have a negative serum/urine pregnancy test within 7 days before enrollment; males must agree to effective contraception during and for 6 months post-study.
• Exclusion Criteria:
• • Patients with undifferentiated thyroid carcinoma or medullary thyroid carcinoma;
• • Patients who have had or currently have other malignancies. The following two situations are eligible for enrollment: other malignancies treated with a single surgery and achieving a disease - free survival (DFS) of 5 consecutive years; cured cervical carcinoma in situ, non - melanoma skin cancer, and superficial bladder tumors \[Ta (non - invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)\].
• • Those with multiple factors affecting oral medications (such as difficulty in swallowing, chronic diarrhea, and intestinal obstruction, etc.);
• • Adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. grade score ≤ 1, except for grade 2 alopecia, grade 2 peripheral neuropathy, grade 2 anemia, non - clinically significant and asymptomatic grade 2 laboratory abnormalities, and hypothyroidism stabilized by hormone replacement therapy, and other toxicities judged by the investigator to have no safety risks.
• • Known allergy to the excipient components of the study drug.
• • Subjects who have participated in and used other anti - tumor clinical trial drugs within 4 weeks before randomization.
• • As judged by the investigator, there are situations that seriously endanger the safety of the subject or affect the subject's completion of the study.