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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04207463
Recruitment Status : Not yet recruiting
First Posted : December 20, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief 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. Anti-angiogenic drugs enhance the infiltration of effector immune cells by inducing normalization of blood vessels and reducing immunosuppression.

Condition or disease Intervention/treatment Phase
Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors Drug: AK105 Drug: Anlotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Anlotinib and AK105 injection
AK105 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)
Drug: AK105
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.

Drug: Anlotinib
a multi-target receptor tyrosine kinase inhibitor




Primary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: up to 96 weeks ]
    Percentage of subjects achieving complete response (CR) and partial response (PR).


Secondary Outcome Measures :
  1. Disease control rate(DCR) [ Time Frame: up to 96 weeks ]
    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

  2. Duration of Response (DOR) [ Time Frame: up to 96 weeks ]
    DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

  3. Progression-free survival (PFS) [ Time Frame: up to 96 weeks ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

  4. Overall survival (OS) [ Time Frame: up to 120 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

    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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04207463


Locations
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China, Beijing
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing, China, 100021
Contact: Aiping Zhou, Doctor    021-38804518    zhouap1825@126.com   
Principal Investigator: Aiping Zhou, Doctor         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04207463    
Other Study ID Numbers: ALTN-AK105-II-02
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Digestive System Neoplasms
Gastrointestinal Neoplasms
Urologic Neoplasms
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms by Site
Urogenital Neoplasms
Digestive System Diseases
Gastrointestinal Diseases