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Biliary Tract CancerPhase 2NCT04784520

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

A Phase 2 study testing HA121-28 tablets in people with Biliary Tract Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Cancer
What is being tested?
HA121-28 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesChina
Study dates
22 Jun 2021to 28 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The First Affiliated Hospital，Sun Yat-sen University

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guanzhou, Guangdong

Other trials in China

About this study

Official title: 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.

Being tested
HA121-28 tablets
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HA121-28 tabletsDrug

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

Study groups in NCT04784520
Study groupRoleWhat they receive
HA121-28 tabletsExperimentalHA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)
Receives: Drug: HA121-28 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

    Measured: Approximately 3.5 years

Secondary outcomes (4)

  1. objective remission rate

    Measured: Approximately 3.5 years

  2. overall survival

    Measured: Approximately 3.5 years

  3. disease control rate

    Measured: Approximately 3.5 years

  4. duration of response

    Measured: Approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start22 Jun 2021
  3. Primary completion28 Dec 2022
  4. Study completion28 Dec 2022

Why it stopped: The primary endpoint did not meet expectation.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04784520
Sponsor's protocol ID
HA122-CSP-002
Status last verified
Feb 2023
First submitted
2 Mar 2021
Last updated
6 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HA121-28 tablets in people with Biliary Tract Cancer, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The primary endpoint did not meet expectation.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: Approximately 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04784520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.

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