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Anaplastic Thyroid CancerPhase 2NCT04574817

Study of HX008 for the Treatment of Anaplastic Thyroid Cancer (ATC)

A Phase 2 study testing HX008 in people with Anaplastic Thyroid Cancer, run by Taizhou Hanzhong biomedical co. LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

There are currently no target therapies approved for treatment of anaplastic thyroid cancer (ATC), leading to a clear need for improving therapy for ATC. This is a single-arm, multicenter study to evaluate the efficacy and safety of HX008 injection in patients with metastatic or locally advanced anaplastic thyroid… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anaplastic Thyroid Cancer
What is being tested?
HX008
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
28 Dec 2020to 30 May 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be willing and able to provide written informed consent for the trial.
  • Age ≥ 18 years old, male or female.
  • Subjects must have histological diagnosis of inoperative IVB or IVC stage anaplastic thyroid cancer.
  • Prior neoadjuvant, adjuvant or palliative chemotherapy for ATC is allowed, there is no limit to the number of prior lines of treatment a patient has received.
  • Have measurable disease based on RECIST 1.1.
  • Willing to provide tissue for PD-L1 biomarker analysis.
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  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Score.
  • Life expectancy ≥ 3 months.
  • Has adequate organ function as defined in the protocol.
  • Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study treatment.
  • Male and female participants should agree to use an adequate method of contraception during the experiment and 6 months after the last administration of the test drugs.

Who cannot join

  • Subjects who are suitable or intent to receive local treatment.
  • Differentiated thyroid cancer (DTC) or medullary thyroid cancer (MTC). ATC arising out of DTC is allowed, as long as the measurable disease is clinically consistent with ATC i.e., rapidly progressive and/or 18F fluorodeoxyglucose (FDG)-avid.
  • Subjects diagnosed with any other malignancy within 3 years prior to the first dose of HX008, except for malignancies with a low risk of metastasis and death (5-year survival rate > 90%), such as basal cell or squamous cell skin cancer or carcinoma in situ of the cervix and other carcinomas in situ.
  • Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, radiation therapy or targeted small molecular therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (≤ Grade 1 or at Baseline) from AEs due to a previously administrated agent.
  • Has had prior herbal medicine within 1 week prior to the first dose of trial treatment.
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  • Has received prior therapy with an anti-PD-1, or anti-PD-L1, or anti-CTLA-4 agents.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has active autoimmune disease that has required systemic treatment in past 2 years.
  • Has received a major surgery within 4 weeks prior to the first dose of trial treatment.
  • Has received system treatment with corticosteroids (dose >10mg/day prednison or other therapeutic hormones) within 2 weeks prior to the first dose of trial treatment.
  • Has a history of interstitial lung disease.
  • Has uncontrolled cardiovascular disease, including but not limited to: 1) heart failure greater than New York Heart Association (NYHA) class II; 2) unstable angina pectoris; 3) has myocardial infarction within 1 year; 4) supraventricular or ventricular arrhythmias with clinical significance.
  • Has uncontrolled systemic disease, such as diabetes or hypertension.
  • Has a history of active tuberculosis.
  • Has a history of testing positive for human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS), or stem cell transplantation or organ transplantation.
  • Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Has untreated chronic hepatitis B or chronic hepatitis B virus (HBV) DNA exceeding 500 IU/ mL or active hepatitis C virus (HCV). Subjects with non-active HBsAg carriers, treated and stable hepatitis B (HBV DNA < 10^3 copies/ml or <500 IU/ mL) , and cured hepatitis C can be enrolled. Subjects with positive HCV antibodies are eligible only if the HCV RNA test results are negative.
  • Has a history of severe allergic reaction to any other monoclonal antibodies.
  • Has active infections requiring systemic treatment within 2 weeks prior to the first dose of trial treatment.
  • Has participated in other anticancer drug clinical trials within 4 weeks.
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
  • Has received a live vaccine within 30 days prior to the first dose of trial treatment.
  • According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial locations and contacts

1 site in 1 country.

Yuankai Shi contact

010-87788293

syuankai@cicams.ac.cn

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, 010-87788293, syuankai@cicams.ac.cn

Other trials in China

About this study

Official title: A Single-arm, Open-lable, Multicenter, Phase II Clinical Study of HX008 in Subjects With Anaplastic Thyroid Cancer

There are currently no target therapies approved for treatment of anaplastic thyroid cancer (ATC), leading to a clear need for improving therapy for ATC. This is a single-arm, multicenter study to evaluate the efficacy and safety of HX008 injection in patients with metastatic or locally advanced anaplastic thyroid cancer.

Being tested
HX008
Medical subject headings
Thyroid Carcinoma, Anaplastic

What participants receive

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

  • HX008Drug

    200 mg administered as IV infusion on Day 1 of each 21-day cycle.

Study groups in NCT04574817
Study groupRoleWhat they receive
HX008ExperimentalParticipants will receive HX008 200 mg intravenous (IV) every 3 weeks (Q3W)
Receives: Drug: HX008

What is being measured

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

  1. Objective Response Rate (ORR)

    Percentage of subjects achieving complete response (CR) and partial response (PR)

    Measured: Up to approximately 30 months

Secondary outcomes (5)

  1. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD)

    Measured: Up to approximately 30 months

  2. Duration of Response (DOR)

    DOR was defined as the time from the first documented evidence of a response of CR or PR to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 30 months

  3. Progression-free Survival (PFS)

    PFS was defined as the time from the date of beginning of HX008 administration to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: Up to approximately 30 months

  4. Overall Survival (OS)

    OS was defined as the time from the date of beginning of HX008 administration until date of death from any cause.

    Measured: Up to approximately 30 months

  5. Adverse Effect (AE)

    Adverse events associated with HX008

    Measured: Up to approximately 30 months

Timeline

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

  1. First posted5 Oct 2020
  2. Study start28 Dec 2020 (estimated)
  3. Primary completion30 May 2022 (estimated)
  4. Study completion30 May 2023 (estimated)

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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04574817
Sponsor's protocol ID
HX008-II-ATC-01
Status last verified
Sep 2020
First submitted
29 Sep 2020
Last updated
5 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HX008 in people with Anaplastic Thyroid Cancer, run by Taizhou Hanzhong biomedical co. LTD at 1 site 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 11 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Yuankai Shi (010-87788293, syuankai@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to approximately 30 months). 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 NCT04574817.

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 5 Oct 2020.

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