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

February 7, 2022 updated by: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Beijing Tongren Hospital
        • Contact:
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • Gansu Province Tumor Hospital
        • Contact:
          • Qinjiang Liu
          • Phone Number: 13519607327
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Not yet recruiting
        • Henan Province Tumor Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Not yet recruiting
        • Jiangsu Province Tumor Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Cancer Hospital of Fudan University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Contact:
          • Chao Li
          • Phone Number: 18081892592
    • Tianjin
      • Tianjin, Tianjin, China, 300600
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
      • Tianjin, Tianjin, China, 300600
        • Recruiting
        • Tianjin People's Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Not yet recruiting
        • The First Affiliated Hospital Of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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);
  11. Patients who have undergone major surgery or have not recovered from invasive operation within 4 weeks prior to initiation of study treatment;
  12. Patients with bleeding diathesis (such as active peptic ulcer) or treated with anticoagulants or vitamin K antagonists, such as warfarin, heparin or their analogues;
  13. 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);
  14. Patients with known history of neurological or psychiatric disorders, including epilepsy or dementia;
  15. Not suitable for the study assessed by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HA121-28 tablets
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
HA121-28 450 mg, po, QD×21 days, every 4 weeks (28 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate (ORR)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: From date of randomization until the date of first documented progression, assessed up to 60 months
assessed approximately every 8 weeks or 12 weeks based on the treatment cycle
From date of randomization until the date of first documented progression, assessed up to 60 months
Duration of response (DOR)
Time Frame: 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
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
Overall survival (OS)
Time Frame: From date of randomization until date of death from any cause, assessed up to 60 months
assessed approximately every 12 weeks
From date of randomization until date of death from any cause, assessed up to 60 months
Disease control rate (DCR)
Time Frame: 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
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
Changes in blood calcitonin
Time Frame: 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
assessed approximately every 8 weeks
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
Adverse events incidence
Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months
assessed approximately every 4 weeks
From date of randomization until the date of death from any cause, assessed up to 60 months
Plasma drug concentration
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, wihichever came first, assessed up to 60 months
assessed approximately every 4 weeks
From date of randomization until the date of first documented progression or date of death from any cause, wihichever came first, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

  • Study Director: Wen Xu, Master, CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 13, 2021

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 1, 2025

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (ACTUAL)

March 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA122-CSP-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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