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QL1604 Monotherapy for dMMR or MSI-H Advanced Solid 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: NCT04326829
Recruitment Status : Not yet recruiting
First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Qilu Pharmaceutical Co., Ltd.

Brief Summary:
In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with QL1604 monotherapy.

Condition or disease Intervention/treatment Phase
Advanced Malignant Tumor Drug: QL1604 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-arm, Multi-center, Phase Ⅱ Clinical Study to Evaluate Efficacy and Safety of QL1604 Monotherapy for the Treatment of Unresectable or Metastatic Mismatch Repair Deficient (dMMR) or Microsatellite Instability-high (MSI-H) Solid Tumors That Failed to Respond to Standard Therapy
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: QL1604 Injection Drug: QL1604
QL1604, IV infusion




Primary Outcome Measures :
  1. ORR [ Time Frame: up to 2 years ]
    Objective response rate (assessed by independent radiological review committee (IRRC) per RECIST Version 1.1 and iRECIST)


Secondary Outcome Measures :
  1. ORR [ Time Frame: up to 2 years ]
    Objective response rate (assessed by the investigators per RECIST Version 1.1 and iRECIST)

  2. 6-month PFS rate [ Time Frame: the proportion of subjects who have time interval over 6 months between the first dose and disease progression or death ]
    6-month progression-free survival (PFS) rate

  3. 6-month OS rate [ Time Frame: from the date of first dose until the date of 6-month ]
    6-month overall survival rate

  4. PFS [ Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years ]
    Progression-free survival (assessed by independent radiological review committee (IRRC) per RECIST v1.1 and iRECIS)

  5. PFS [ Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years ]
    Progression-free survival (assessed by the investigators per RECIST v1.1 and iRECIST)

  6. OS [ Time Frame: from the date of first dose until the date of death from any cause, assessed up to 2 years ]
    Overall survival

  7. DOR [ Time Frame: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier), assessed up to 2 years ]
    Duration of response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
  2. Age ≥ 18 years and ≤ 80 years when ICF is signed;
  3. Histologically confirmed locally advanced or metastatic dMMR or MSI-H status colorectal carcinoma or other malignant solid tumors;
  4. At least one measureable lesion as defined per RECIST Version (v) 1.1 ;
  5. Subjects who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received or refused prior cancer therapy regimen(s) ;
  6. Subjects must provide tumor tissues and blood samples for the determination of MSI, tumor mutational burden (TMB), PD-L1 expression level;
  7. Eastern Cooperative Oncology Group performance status of 0 or 1;
  8. Life expectancy of greater than 12 weeks;
  9. Adequate hematologic and organ function;
  10. Female subjects who are not pregnant or breastfeeding
  11. Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 120 days after last dose.

Exclusion Criteria:

  1. Known hypersensitivity to any monoclonal antibody, QL1604 and/or any of its excipients;
  2. Subjects with known central nervous system (CNS) metastasis;
  3. Active autoimmune disease that has required systemic treatment in past 2 years, replacement therapy is acceptable;
  4. Subjects with major cardiovascular and cerebrovascular diseases;
  5. Subjects with uncontrollable pleural effusion, pericardial effusion or ascites;
  6. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug;
  7. Subjects who have received surgery, radiotherapy, chemotherapy, targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product;
  8. Subjects who have not recovered to CTC AE Grade 1 or better from related side effects of any prior antineoplastic therapy;
  9. Received a live vaccine within 30 days of planned start of study medication;
  10. Infection with human immunodeficiency virus (HIV), HAV, HBV and HCV;
  11. Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand 1 (anti-PD-L1), anti-PD-L2 agent, cytotoxic lymphocyte associated protein-4 (CTLA-4), OX-40, CD137;
  12. Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
  13. History or current evidence of any condition, therapy, or laboratory abnormality, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study, or investigators/sponsor consider the subjects are not suitable for this trial.

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): NCT04326829


Contacts
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Contact: Shunjiang Yu, CMO 0531-83129659 shunjiang.yu@qilu-pharma.com
Contact: Weijian Guo, Professor 021-64175590

Locations
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China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 2000 32
Contact: Weijian Guo, Professor    021-64175590      
Principal Investigator: Weijian Guo, Professor         
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Contact: Feng Bi, Professor         
Sponsors and Collaborators
Qilu Pharmaceutical Co., Ltd.
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Responsible Party: Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04326829    
Other Study ID Numbers: QL1604-201
First Posted: March 30, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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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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Neoplasms