Trials / Unknown
UnknownNCT04207463
A Study of Anlotinib and AK105 Injection in Subjects With Gastrointestinal Tumors, Urinary System Tumors, Neuroendocrine Tumors
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-06-03
- Primary completion
- 2020-12-31
- Completion
- 2021-05-30
- First posted
- 2019-12-20
- Last updated
- 2020-06-17
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04207463. Inclusion in this directory is not an endorsement.