Trials / Unknown
UnknownNCT04527068
QL1101 in Combination With JS001 in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer
QL1101A,a Biosimilar of Bevacizumab,in Combination With JS001,a Anti-pd-1 Antibody in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer: a Single-arm,Open-Label, Prospective, Single-center Study
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a single-arm,open-label, prospective, single-center Study of QL1101 and JS001 in patients with pMMR/MSS refractory metastatic colorectal cancer. QL1101 is a biosimilar of bevacizumab (Avastin) produced and provided by Qilu Pharmaceutical Co., Ltd., which has been marketed in China.It's a humanized monoclonal IgG1 antibody prepared by recombinant DNA technology. By binding to human vascular endothelial growth factor (VEGF), it inhibits the binding of VEGF to its receptor, blocks the signal transduction pathway of angiogenesis, and inhibits tumor cell growth. Be produced and provided by Shanghai Junshi Bioscience Co., Ltd. ,JS001(Tripleitriumab) is the first China-developed humanized monoclonal antibody against programmed death 1 (PD-1) approved for marketing in China. Antiangiogenic drugs combined with PD-1 monoclonal antibodies may reverse the insensitivity of pMMR/MSS refractory colorectal cancer to PD-1 inhibitors. The primary objective of this study is to investigate the safety and efficacy of the subjects who given the combination therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bevacizumab | 7.5 mg/kg intravenously every 3week |
| DRUG | Tripleitriumab | 240mg intravenously every 3week |
Timeline
- Start date
- 2020-09-20
- Primary completion
- 2021-09-01
- Completion
- 2022-02-01
- First posted
- 2020-08-26
- Last updated
- 2020-09-17
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04527068. Inclusion in this directory is not an endorsement.