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

NCT04203719 | Unknown Phase 2 DMC

• 1 other identifier: ALTN-AK105-II-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Head, Neck and Chest Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

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

  up to 96 weeks

Secondary Outcomes (4)

• Disease control rate（DCR）

  up to 96 weeks

• Duration of Response (DOR)

  up to 96 weeks

• Progression-free survival (PFS)

  up to 96 weeks

• Overall survival (OS)

  up to 120 weeks

Study Arms (1)

Anlotinib and AK105 injection

EXPERIMENTAL

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; Drug: Anlotinib

Interventions

AK105 DRUG

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.

Anlotinib and AK105 injection

Anlotinib DRUG

a multi-target receptor tyrosine kinase inhibitor

Anlotinib and AK105 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• 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.
• \. 18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
• \. At least one measurable lesion. 4. Providing tumor specimen obtained by biopsy or surgical sample within 2 years.
• 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.
• \. Understood and signed an informed consent form.

You may not qualify if:

• 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.
• Has brain metastases with symptoms or symptoms control for less than 2 months.
• Has diagnosed and/or treated additional malignancy within 5 years prior to the first dose.
• Has multiple factors affecting oral medication. 5.Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• 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.
• Has received surgery, or unhealed wounds within 4 weeks before the first dose.
• \. 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.
• \. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal or its components.
• Has active autoimmune diseases requiring systemic therapy within 2 years prior to the first dose.
• 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.
• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39371104 DERIVED

MeSH Terms

Interventions

anlotinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 18, 2019
• Study Start: May 9, 2020
• Primary Completion: December 31, 2020
• Study Completion: May 30, 2021
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

CN (1)