QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Tumor
• Intervention / Treatment: Drug: QL1604

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Weijian Guo, Professor; Phone Number: 021-64175590

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 2000 32
      • Recruiting
      • Fudan University Cancer Hospital
      • Contact: Weijian Guo, Professor; Phone Number: 021-64175590
      • Principal Investigator: Weijian Guo, Professor
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
      • Contact: Feng Bi, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QL1604 Injection	Drug: QL1604; QL1604, IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate (assessed by independent radiological review committee (IRRC) per RECIST Version 1.1 and iRECIST)	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate (assessed by the investigators per RECIST Version 1.1 and iRECIST)	up to 2 years
6-month PFS rate	6-month progression-free survival (PFS) rate	the proportion of subjects who have time interval over 6 months between the first dose and disease progression or death
6-month OS rate	6-month overall survival rate	from the date of first dose until the date of 6-month
PFS	Progression-free survival (assessed by independent radiological review committee (IRRC) per RECIST v1.1 and iRECIS)	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
PFS	Progression-free survival (assessed by the investigators per RECIST v1.1 and iRECIST)	from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years
OS	Overall survival	from the date of first dose until the date of death from any cause， assessed up to 2 years
DOR	Duration of response	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

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: QL1604-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No