QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors

NCT04326829 | Unknown Phase 2

• 1 other identifier: QL1604-201
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate (assessed by independent radiological review committee (IRRC) per RECIST Version 1.1 and iRECIST)

  up to 2 years

Secondary Outcomes (7)

• ORR

  up to 2 years

• 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 OS rate

  from the date of first dose until the date of 6-month

• PFS

  from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years

• PFS

  from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years

Study Arms (1)

QL1604 Injection

EXPERIMENTAL

Drug: QL1604

Interventions

QL1604 DRUG

QL1604, IV infusion

QL1604 Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
• Age ≥ 18 years and ≤ 80 years when ICF is signed;
• Histologically confirmed locally advanced or metastatic dMMR or MSI-H status colorectal carcinoma or other malignant solid tumors;
• At least one measureable lesion as defined per RECIST Version (v) 1.1 ;
• 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) ;
• Subjects must provide tumor tissues and blood samples for the determination of MSI, tumor mutational burden (TMB), PD-L1 expression level;
• Eastern Cooperative Oncology Group performance status of 0 or 1;
• Life expectancy of greater than 12 weeks;
• Adequate hematologic and organ function;
• Female subjects who are not pregnant or breastfeeding
• 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.

You may not qualify if:

• Known hypersensitivity to any monoclonal antibody, QL1604 and/or any of its excipients;
• Subjects with known central nervous system (CNS) metastasis;
• Active autoimmune disease that has required systemic treatment in past 2 years, replacement therapy is acceptable;
• Subjects with major cardiovascular and cerebrovascular diseases;
• Subjects with uncontrollable pleural effusion, pericardial effusion or ascites;
• 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;
• 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;
• Subjects who have not recovered to CTC AE Grade 1 or better from related side effects of any prior antineoplastic therapy;
• Received a live vaccine within 30 days of planned start of study medication;
• Infection with human immunodeficiency virus (HIV), HAV, HBV and HCV;
• 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;
• Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 2000 32, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

• Bi F, Dong J, Jin C, Niu Z, Yang W, He Y, Yu D, Sun M, Wang T, Yin X, Zhang R, Chen K, Wang K, Wang Z, Li W, Zhang Z, Zhang H, Guo Q, Wang X, Han L, Zhang X, Shen W, Zhang L, Ying J, Wu M, Hu W, Li Z, Li X, Feng W, Zhang B, Li L, Kang X, Guo W. Iparomlimab (QL1604) in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic solid tumors: a pivotal, single-arm, multicenter, phase II trial. J Hematol Oncol. 2024 Nov 11;17(1):109. doi: 10.1186/s13045-024-01627-5.

  PMID: 39529169 DERIVED

Central Study Contacts

Shunjiang Yu, CMO

CONTACT

0531-83129659; shunjiang.yu@qilu-pharma.com

Weijian Guo, Professor

CONTACT

021-64175590

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: July 8, 2020
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-11

Locations

CN (2)