QL1101 in Combination With JS001 in Patients With pMMR/MSS Refractory Metastatic Colorectal Cancer

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT04527068
Phase
PHASE2
Status
Unknown

Conditions

  • MSS
  • Refractory Metastatic Colorectal Cancer
  • pMMR

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    7.5 mg/kg intravenously every 3week
  • Tripleitriumab — DRUG
    240mg intravenously every 3week

Study Details

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.

Key Dates

First listed
Aug 26, 2020
Start date
Sep 20, 2020
Status verified
Aug 2020
Primary completion
Sep 1, 2021
Completion
Feb 1, 2022

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab +Tripleitriumab
    Participants receive bevacizumab 7.5mg/kg and tripleitriumab 240mg in day 1 intravenously every 3week until disease progression or unacceptable toxicity

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From the first use of research drugs to documented disease progression per RECIST 1.1 and iRECIST or death from any cause, whichever occurs first, assessed up to 18 months ]

Central Contacts

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