A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer

A Multicentre, Open-label, Single-arm Phase II Study of HA121-28 Tablets in Advanced Biliary Tract Cancer (BTC)

This study is a multicenter, open-label, single-arm phase II study to evaluate efficacy, safety, and pharmacokinetics characteristics of HA121-28 tablets in advanced biliary tract cancer (BTC). A total of approximately 30 subjects with advanced BTC will be enrolled. The subjects will undergo a 3 weeks-on and 1week-off treatment scheme with HA121-28 tablets 600 mg orally once daily in the 28-day cycle until disease progression or intolerable toxic reaction, whichever occurs first.

Study Overview

• Status: Terminated
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Drug: HA121-28 tablets

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wen Xu; Phone Number: 010-63932012; Email: xuwen@mail.ecspc.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital,Sun Yat-sen University
    • Guanzhou, Guangdong, China
      • Sun Yat-Sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be willing to participate in the clinical trial and sign the informed consent;
• Histologically/cytologically confirmed unresectable locally advanced or metastatic BTC (including cholangiocarcinoma or gallbladder cancer) with failure of or intolerance to the prior therapy (including disease progression within 6 months after adjuvant chemotherapy) and with at least one measurable lesion based on RECIST 1.1 criteria;
• Aged 18 to 75 years (inclusive);
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1;
• Routine blood test results must meet the following criteria without blood transfusion within 14 days: 1) Hemoglobin (Hb)≥90 g/L; 2) Absolute neutrophil count (ANC)≥1.5 x 10^9/L; 3) Platelet count (PLT)≥75×10^9/L;
• Coagulation test results must meet the following criteria: International Normalized Ratio (INR) <1.5 or Activated Partial Thromboplastin Time (APTT) <1.5×ULN;
• Other laboratory test results must meet all the following criteria: 1) Total bilirubin (TBIL)≤1.5×ULN, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN (TBIL≤3×ULN, ALT and AST≤5×ULN in the subjects with liver metastasis); 2) Serum creatinine≤1.5×ULN；3) Serum albumin≥28g/L;
• Male and female subjects of childbearing potential must agree to take effective contraception for the duration of treatment and for 6 months after completion of study drug administration; female subjects must have negative results of serum/urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.

Exclusion Criteria:

• Subjects with ampullary carcinoma;
• Subjects who had participated in other clinical trials and received the treatment within 4 weeks prior to enrolment;
• The time interval between the end of the last antitumor treatment and the first administration of HA121-28 tablets < 4 weeks (for any antitumor treatment, including but not limited to chemotherapy, radiotherapy and targeted therapy), or < 2 weeks (for local palliative radiotherapy for pain relief or traditional Chinese medicine with approved indications for cancer);
• Urine protein≥2+ and urine protein > 1.0g/24h;
• History of other malignancies within the past 5 years prior to enrolment, except for cured cervical carcinoma in situ, non-melanoma skin cancer, superficial bladder tumor, and early esophageal and gastrointestinal cancers that were confined to the mucosal layer and resected under endoscopy;
• History of any solid-organ or bone-marrow transplantation (except the transplantation without immunosuppression such as corneal and hair transplantation);
• Unremitted toxic reaction>grade 1 due to any previous treatment at the time of enrollment (except for hair loss and pigmentation) which is considered to influence the safety evaluation;
• ECG meets one of the following criteria: 1) QT/QTc interval≥450ms, congenital long QT syndrome (LQTS) or family history of LQTS; 2) any clinically significant abnormalities of rhythm, conduction or morphology in the resting ECG requiring therapeutic intervention;
• Left ventricular ejection fraction (LVEF) <50% in echocardiogram;
• Severe concomitant diseases which may have influence on the safety of the subjects or the completion of the study based on the investigator' judgement such as uncontrolled hypertension (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg after treatment);
• High risk factors of gastrointestinal diseases such as gastrointestinal perforation and abdominal fistula;
• Subjects with spinal cord, meningeal or brain metastasis (except for asymptomatic or stable brain metastasis within 4 weeks prior to administration);
• Subjects with hepatopathy meet one of the following criteria: 1) HBsAg positive and HBV DNA >2000 IU/mL（or >1×10^4 copies/mL）; 2) HCV antibody positive and HCV RNA positive; 3) cirrhosis;
• HIV antibody positive;
• Subjects have history of surgery within 4 weeks prior to administration or have not been recovered from any previous invasive procedure, except for biliary stenting, biliary drainage, etc.;
• Not suitable for the study in the investigator's opinion.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: HA121-28 tablets; HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)	Drug: HA121-28 tablets; HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	Approximately 3.5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
objective remission rate	Approximately 3.5 years
overall survival	Approximately 3.5 years
disease control rate	Approximately 3.5 years
duration of response	Approximately 3.5 years

Other Outcome Measures

Outcome Measure	Time Frame
adverse events incidence	Approximately 3.5 years
HA121-28 plasma concentration	Approximately 3.5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 22, 2021
• Primary Completion (ACTUAL): December 28, 2022
• Study Completion (ACTUAL): December 28, 2022

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms
• Other Study ID Numbers: HA122-CSP-002

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