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QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors

Sponsor
Qilu Pharmaceutical Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04326829
Collaborator
(none)
86
Enrollment
2
Locations
1
Arm
26
Anticipated Duration (Months)
43
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: QL1604 Injection

Drug: QL1604
QL1604, IV infusion

Outcome Measures

Primary Outcome Measures

  1. ORR [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 [up to 2 years]

    Objective response rate (assessed by the investigators per RECIST Version 1.1 and iRECIST)

  2. 6-month PFS rate [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 [from the date of first dose until the date of 6-month]

    6-month overall survival rate

  4. PFS [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 [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 [from the date of first dose until the date of death from any cause， assessed up to 2 years]

    Overall survival

  7. DOR [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fudan University Cancer Hospital Shanghai Shanghai China 2000 32
2 West China Hospital, Sichuan University Chengdu Sichuan China 610041

Sponsors and Collaborators

  • Qilu Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04326829
Other Study ID Numbers:
  • QL1604-201
First Posted:
Mar 30, 2020
Last Update Posted:
Mar 30, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Mar 30, 2020