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A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC) | Clinical Trials | Clareo Health

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A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)

A Single-arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)

NCT04787328•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a single-arm, open-label, multicenter study designed to evaluate the preliminary antineoplastic activity, safety and tolerability of HA121-28 tablets administered orally in patients with medullary thyroid cancer (MTC).

Detailed Description

A total of approximately 30 patients with MTC will be enrolled. The patients will undergo a 3 weeks-on and 1week-off treatment scheme with HA121-28 tablets 450 mg orally once daily in the 28-day cycle until disease progression or intolerable toxic reaction, whichever occurs first. During the administration of HA121-28 tablets, vital signs, physical examination, ECOG performance status, hematology and chemistry test, ECG, adverse events and concomitant drugs will be evaluated every four weeks, an additional ECG will be observed two weeks after the first dose, calcitonin and pregnancy test will be performed every 8 weeks. CT for tumor assessment will be performed every 8 weeks for the first year, and every 12 weeks thereafter.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be willing to participate in the clinical trial and sign the informed consent;
•2. Men and women aged ≥18 years;
•3. Histologically confirmed unresectable locally advanced or metastatic MTC with at least one measurable lesion per RECIST1.1;
•4. Evidence of disease progression within 12 months prior to signing informed consent;
•5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1;
•6. Laboratory test results must meet the following criteria: Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L; Platelet count (PLT) ≥75×10\^9/L; Hemoglobin (Hb) ≥90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x upper limit of normal (ULN) (in patients with liver metastasis ≤5.0 x ULN); Total bilirubin ≤ 1.5 x ULN; Serum creatinine≤ 1.5 x ULN；Prothrombin time (PT) and activated Partial Thromboplastin Time (APTT) ≤ 1.5 x ULN；
•7. Left ventricular ejection fraction (LVEF)≥50% in echocardiogram；
•8. Male and female subjects of childbearing potential must agree to take effective contraception during the treatment period and for 6 months after the last dose of study medication;
•9. Female participants must have negative results of serum/urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.

Exclusion Criteria

•1. Previous treatment with selective RET inhibitor, such as blu-667, loxo-292, etc.;
•2. Patients who had participated in other clinical trials and received the treatment within 4 weeks prior to enrollment;
•3. Systemic anti-tumor treatment such as small molecule targeted drugs, cytotoxic drugs, immunotherapy and radiotherapy within 4 weeks of the first dose of the study drug, or local palliative radiotherapy for pain relief within 2 weeks;;
•4. Patients who cannot swallow or have chronic diarrhea (except for those induced by MTC) and intestinal obstruction, or other factors which may affect the administration and absorption of the study drug;
•5. History of other malignancies within the past 5 years or currently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumor;
•6. Patients who meet one of the following criteria: 1) Corrected QT (QTc) ≥450 ms (corrected using Fridericia's formula (QTcF): QTcF = QT/(RR\^0.33)); 2) Any clinically significant abnormalities of rhythm, conduction or morphology in the resting electrocardiogram (ECG) requiring therapeutic intervention;
•7. Urine protein≥2+ and urine protein \> 1.0 g/24h;
•8. Known severe concomitant and/or uncontrolled diseases, including but not limited to: 1)Uncontrolled hypertension (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg, after treatment); 2)Significant cardiovascular and cerebrovascular events, arterial or venous fistulae thrombotic events, myocardial infarction, congestive heart failure (NYHA classification ≥2) or severe ventricular arrhythmia within 6 months of the first dose of the study drug; 3) Liver cirrhosis, decompensated liver disease; 4) Renal failure required hemodialysis or peritoneal dialysis; 5) History of human immunodeficiency, including HIV positive, or other acquired/congenital immune deficiency diseases, or history of organ or bone marrow transplantation; 6) Uncontrolled pericardial effusion, pleural effusion or ascites;7） interstitial pneumonia required steroid therapy or severe infection required systemic treatment, which is judged not suitable for the study by the investigator;
•9. Patients with spinal cord, meningeal and brain metastases (except for stable symptomatic or asymptomatic brain metastases);
•10. Ongoing adverse events\>grade 1 due to any previous treatment at the time of enrollment (except for hair loss and pigmentation);
+5 more criteria

Locations (13)

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Gansu Province Tumor Hospital

Lanzhou, Gansu, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Henan Province Tumor Hospital

Zhengzhou, Henan, China

Jiangsu province tumor hospital

Nanjing, Jiangsu, China

Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

July 13, 2021

Primary Completion Date

March 1, 2023

Completion Date

March 1, 2025

Last Updated

February 23, 2022

Enrollment

ESTIMATED participants

Conditions

Medullary Thyroid Carcinoma

Interventions

HA121-28 tablets

DRUG

Contacts

Ming Gao, PhD

CONTACT

022-27557550 gming68@aliyun.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of HA121-28 Tablets in Patients With Medullary Thyroid Carcinoma (MTC)

Inclusion Criteria

Exclusion Criteria

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