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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04784520
• Other study ID #: HA122-CSP-002
• Status: Terminated
• Phase: Phase 2
• Start date: June 22, 2021
• Est. completion date: December 28, 2022

Study information

• Verified date: February 2023
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: December 28, 2022
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• HA121-28 tablets
HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)

Locations

Country	Name	City	State
China	The First Affiliated Hospital,Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events incidence		Approximately 3.5 years
Other	HA121-28 plasma concentration		Approximately 3.5 years
Primary	progression-free survival		Approximately 3.5 years
Secondary	objective remission rate		Approximately 3.5 years
Secondary	overall survival		Approximately 3.5 years
Secondary	disease control rate		Approximately 3.5 years
Secondary	duration of response		Approximately 3.5 years