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Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine TumorsPhase 2NCT04207463

A Study of Anlotinib and AK105 Injection in Subjects With Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors

A Phase 2 study testing AK105 and Anlotinib in people with Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
What is being tested?
AK105 and Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
7 sitesChina
Study dates
3 Jun 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：Histopathologically confirmed metastatic or inoperable cholangiocarcinoma failed with first-line or above chemotherapy.
  • Cohort 2： Histopathologically confirmed recurrent or metastatic colorectal cancer that is not suitable for surgery with MSI-H or dMMR.
  • Cohort 3： Histopathologically confirmed metastatic or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.
  • Cohort 4：Histopathologically confirmed local progression or metastatic urothelial carcinoma that is not suitable for surgery.
  • Cohort 5：Low- and medium-grade (G1 or G2) late gastrointestinal pancreatic neuroendocrine tumor (NET) subjects diagnosed by pathology." 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.The main organs function are normally. 5. 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.
  • 6. 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. HER2 positive in cohort 3. 3. Has received chemotherapy, radiotherapy or other treatments within 4 weeks prior to the first dose.
  • 4.Has brain metastases with symptoms or symptoms control for less than 2 months.
  • 5.Has diagnosed and/or treated additional malignancy within 5 years prior to the first dose.
  • 6.Has multiple factors affecting oral medication. 7.Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • 8.Has unrelieved spinal cord compression. 9.Imaging shows that tumors invade large blood vessels. 10.Has hemoptysis within 1 month prior to the first dose and maximum daily hemoptysis ≥2.5 mL.
Show all 12Show fewer
  • 11.Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
  • 12.Has received surgery, or unhealed wounds within 4 weeks before the first dose.
  • 13. Has artery/venous thrombosis prior to the first dose within 6 months. 14. Has drug abuse history that unable to abstain from or mental disorders 15. Has any serious and / or uncontrolled disease. 16. Has received vaccination or attenuated vaccine within 4 weeks prior to the first dose.
  • 17.Hypersensitivity to recombinant humanized anti-PD-1 monoclonal or its components.
  • 18. 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.
  • 19.Diagnosed as immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose >10 mg/day of prednisone or other therapeutic hormones) and continued to be used for 2 weeks prior to the first dose 20. Has participated in other anticancer drug clinical trials within 4 weeks. 21. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites, 7 recruiting

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

    Beijing, Beijing Municipality, 100021

    Aiping Zhou, Doctor, 021-38804518, zhouap1825@126.com

    Aiping Zhou, Doctor

    Recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Yunbo Zhao, Doctor, 010-85136715

    Yunbo Zhao, Doctor

    Not yet recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Jianfeng Zhou, Doctor, 010-69158750

    Jianfeng Zhou, Doctor

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Jilin, 150081

    Yanqiao Zhang, Doctor, 0451-86298278

    Yanqiao Zhang, Doctor

    Not yet recruiting

  • Jinan Central Hospital

    Jinan, Shandong, 250013

    Yuping Sun, Doctor, 0531-68623306

    Yuping Sun, Doctor

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

    Jifeng Feng, Doctor, 025-83283415

    Jifeng Feng, Doctor

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Xi’an, Shanxi, 710061

    Zijun Liao, Doctor, 029-85276142

    Zijun Liao, Doctor

    Not yet 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 Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors

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
Medical subject headings
Digestive System Neoplasms, Neuroendocrine Tumors

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 NCT04207463
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 posted20 Dec 2019
  2. Study start3 Jun 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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04207463
Sponsor's protocol ID
ALTN-AK105-II-02
Status last verified
Jun 2020
First submitted
17 Dec 2019
Last updated
17 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK105 and Anlotinib in people with Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 7 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 7 inclusion and 12 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 17 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 7 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?

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 NCT04207463.

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 17 Jun 2020.

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