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

NCT04787328 | Unknown Phase 2

• 1 other identifier: HA122-CSP-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 13

Brief 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).

Conditions

Medullary Thyroid Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective remission rate (ORR)

  assessed approximately every 8 weeks or 12 weeks based on the treatment cycle

  From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months

Secondary Outcomes (7)

• Progression-free survival (PFS)

  From date of randomization until the date of first documented progression, assessed up to 60 months

• Duration of response (DOR)

  From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months

• Overall survival (OS)

  From date of randomization until date of death from any cause, assessed up to 60 months

• Disease control rate (DCR)

  From date of randomization until the date of first documented progression or date of death from any cause,whichever came first, assessed up to 60 months

• Changes in blood calcitonin

  From date of randomization until the date of first documented progression or date of death from any cause, or date of death from any cause,whichever came first, assessed up to 60 months

Study Arms (1)

HA121-28 tablets

EXPERIMENTAL

Patients will receive HA121-28 tablets at 450 mg once daily (QD) for 21 days on a 28-day treatment cycle.

Drug: HA121-28 tablets

Interventions

HA121-28 tablets DRUG

HA121-28 450 mg, po, QD×21 days, every 4 weeks (28 days)

HA121-28 tablets

Eligibility Criteria

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

You may qualify if:

• Be willing to participate in the clinical trial and sign the informed consent;
• Men and women aged ≥18 years;
• Histologically confirmed unresectable locally advanced or metastatic MTC with at least one measurable lesion per RECIST1.1;
• Evidence of disease progression within 12 months prior to signing informed consent;
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1;
• 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；
• Left ventricular ejection fraction (LVEF)≥50% in echocardiogram；
• 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;
• Female participants must have negative results of serum/urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.

You may not qualify if:

• Previous treatment with selective RET inhibitor, such as blu-667, loxo-292, etc.;
• Patients who had participated in other clinical trials and received the treatment within 4 weeks prior to enrollment;
• 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;;
• 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;
• 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;
• 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;
• Urine protein≥2+ and urine protein \> 1.0 g/24h;
• 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;
• Patients with spinal cord, meningeal and brain metastases (except for stable symptomatic or asymptomatic brain metastases);
• Ongoing adverse events\>grade 1 due to any previous treatment at the time of enrollment (except for hair loss and pigmentation);
• Patients who have undergone major surgery or have not recovered from invasive operation within 4 weeks prior to initiation of study treatment;
• Patients with bleeding diathesis (such as active peptic ulcer) or treated with anticoagulants or vitamin K antagonists, such as warfarin, heparin or their analogues;
• Known active Hepatitis B or Hepatitis C virus infection: HBsAg positive with HBV DNA higher than the lower limit of detection range of the site, or HCV antibody positive with HCV RNA higher than the lower limit of detection range of the site);
• Patients with known history of neurological or psychiatric disorders, including epilepsy or dementia;
• Not suitable for the study assessed by the investigators.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (13)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100000, China

NOT YET RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Gansu Province Tumor Hospital

Lanzhou, Gansu, 730000, China

NOT YET RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510080, China

RECRUITING

Henan Province Tumor Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Jiangsu province tumor hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300600, China

NOT YET RECRUITING

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 300600, China

RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310022, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Medullary

Condition Hierarchy (Ancestors)

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Study Officials

• Wen Xu, Master

  CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Ming Gao, PhD

CONTACT

022-27557550; gming68@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 8, 2021
• Study Start: July 13, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2025
• Last Updated: February 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)