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Advanced Head, Neck and Chest CancerPhase 2NCT04203719

A Study of Anlotinib and AK105 Injection in Subjects With Advanced Head, Neck and Chest Cancer

A Phase 2 study testing AK105 and Anlotinib in people with Advanced Head, Neck and Chest Cancer, run by Chia Tai Tianqing Pharmaceutical Group 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 The sponsor has not verified this record for over two years, so it may be out of date.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

AK105 is a humanized monoclonal antibody that specially binds to PD-1. Anlotinib is a small molecule tyrosine kinase inhibitor. Based on the mechanism study, tumor vascular abnormalities promote tissue hypoxia and increase lactic acid, thereby activating immunosuppression and inhibiting T cell function. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Head, Neck and Chest Cancer
What is being tested?
AK105 and Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
9 May 2020to 30 May 2021
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

  • 1. Cohort 1：Histologically or cytologically confirmed head and neck squamous cell cancer, primary tumor sites including oropharynx, oral cavity, hypopharynx, or larynx.
  • Cohort 2：Histologically confirmed advanced/metastatic head and neck non-squamous cell cancer failed with standard treatment.
  • Cohort 3：Histologically confirmed undifferentiated thyroid cancer not suitable for surgery and failed with standard treatment.
  • Cohort 4：Histologically confirmed small cell lung cancer failed with only one platinum-containing chemotherapy.
  • Cohort 5：Histologically confirmed stage IIIB to IV non-squamous cell lung cancer failed with standard treatment.
  • Cohort 6：Histologically confirmed stage IIIB to IV squamous non-small cell lung cancer failed with at least one platinum-containing or other double-drug chemotherapy.
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  • Cohort 7：Histologically confirmed recurrent/metastasis pleural mesothelioma and thymic cancer failed with at least one-line chemotherapy and not suitable for surgery or radiotherapy.
  • 2. 18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
  • 3. At least one measurable lesion. 4. Providing tumor specimen obtained by biopsy or surgical sample within 2 years.
  • 5.The main organs function are normally. 6. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
  • 7. Understood and signed an informed consent form.

Who cannot join

  • 1.Has used anti-angiogenic drugs such as bevacizumab,erlotinib, apatinib, sorafenib, sunitinib, and endothelium or against PD-1, PD-L1 and other related immunotherapeutic drugs.
  • 2.Has brain metastases with symptoms or symptoms control for less than 2 months.
  • 3.Has diagnosed and/or treated additional malignancy within 5 years prior to the first dose.
  • 4.Has multiple factors affecting oral medication. 5.Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • 6.Has unrelieved spinal cord compression. 7.Imaging shows that tumors invade large blood vessels. 8. Central lung squamous cell carcinoma with hollow. 9.Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
  • 10.Has received surgery, or unhealed wounds within 4 weeks before the first dose.
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  • 11. Has artery/venous thrombosis prior to the first dose within 6 months. 12. Has drug abuse history that unable to abstain from or mental disorders 13. Has any serious and / or uncontrolled disease. 14. Has received vaccination or attenuated vaccine within 4 weeks prior to the first dose.
  • 15. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal or its components.
  • 16.Has active autoimmune diseases requiring systemic therapy within 2 years prior to the first dose.
  • 17.Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first dose.
  • 18.Has participated in other anticancer drug clinical trials within 4 weeks. 19.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, Doctor, 010-87788293, syuankaipumc@126.com

    Yuankai Shi, Doctor

    Recruiting

Other trials in China

About this study

Official title: A Phase II, Open, Single-arm, Multi-cohort, Multicenter Study of Anlotinib and AK105 Injection in Subjects With Advanced Head, Neck and Chest Cancer

AK105 is a humanized monoclonal antibody that specially binds to PD-1. Anlotinib is a small molecule tyrosine kinase inhibitor. Based on the mechanism study, tumor vascular abnormalities promote tissue hypoxia and increase lactic acid, thereby activating immunosuppression and inhibiting T cell function. Anti-angiogenic drugs enhance the infiltration of effector immune cells by inducing normalization of blood vessels and reducing immunosuppression.

Being tested
AK105, Anlotinib

What participants receive

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

  • AK105Drug

    AK105 is a humanized monoclonal antibody that specifically binds to PD-1. AK105 has a typical antibody structure and is composed of two lgG1 subtype heavy chains and two kappa subtypes light chains covalently linked by disulfide bonds.

  • AnlotinibDrug

    a multi-target receptor tyrosine kinase inhibitor

Study groups in NCT04203719
Study groupRoleWhat they receive
Anlotinib and AK105 injectionExperimentalAK105 200mg intravenously (IV) on day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Receives: Drug: AK105; Drug: Anlotinib

What is being measured

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

  1. Overall response rate (ORR)

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

    Measured: up to 96 weeks

Secondary outcomes (4)

  1. Disease control rate（DCR）

    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

    Measured: up to 96 weeks

  2. Duration of Response (DOR)

    DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

    Measured: up to 96 weeks

  3. Progression-free survival (PFS)

    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

    Measured: up to 96 weeks

  4. Overall survival (OS)

    OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

    Measured: up to 120 weeks

Timeline

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

  1. First posted18 Dec 2019
  2. Study start9 May 2020
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion30 May 2021 (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
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04203719
Sponsor's protocol ID
ALTN-AK105-II-01
Status last verified
Jun 2020
First submitted
17 Dec 2019
Last updated
23 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang C, Chen J, Wu H, Wang J, Gao L, Zhao J, Sun Y, Jia Z, Mu X, Bai C, Wang R, Wu K, Liu Q, Shi Y. Efficacy and safety of anlotinib plus penpulimab as second-line treatment for small cell lung cancer: A multicenter, open-label, single-arm phase II trial. Cancer Pathog Ther. 2024 Feb 7;2(4):268-275. doi: 10.1016/j.cpt.2024.02.001. eCollection 2024 Oct.

    PubMed 39371104

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK105 and Anlotinib in people with Advanced Head, Neck and Chest Cancer, run by Chia Tai Tianqing Pharmaceutical Group 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 11 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 23 Jun 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: up to 96 weeks). 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 NCT04203719, which also lists 1 linked publication.

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 23 Jun 2020.

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