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Advanced Malignant TumorPhase 2NCT04326829

QL1604 Monotherapy for dMMR or MSI-H Advanced Solid Tumors

A Phase 2 study testing QL1604 in people with Advanced Malignant Tumor, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Malignant Tumor
What is being tested?
QL1604
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
2 sitesChina
Study dates
8 Jul 2020to Jul 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Shunjiang Yu, CMO contact

0531-83129659

shunjiang.yu@qilu-pharma.com

Weijian Guo, Professor contact

021-64175590

China2 sites, 2 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Feng Bi, Professor

    Recruiting

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 2000 32

    Weijian Guo, Professor, 021-64175590

    Weijian Guo, Professor

    Recruiting

Other trials in China

About this study

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

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.

Being tested
QL1604

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1604Drug

    QL1604, IV infusion

Study groups in NCT04326829
Study groupRoleWhat they receive
QL1604 InjectionExperimentalNot described
Receives: Drug: QL1604

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

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

    Measured: up to 2 years

Secondary outcomes (7)

  1. ORR

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

    Measured: up to 2 years

  2. 6-month PFS rate

    6-month progression-free survival (PFS) rate

    Measured: the proportion of subjects who have time interval over 6 months between the first dose and disease progression or death

  3. 6-month OS rate

    6-month overall survival rate

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

  4. PFS

    Progression-free survival (assessed by independent radiological review committee (IRRC) per RECIST v1.1 and iRECIS)

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

  5. PFS

    Progression-free survival (assessed by the investigators per RECIST v1.1 and iRECIST)

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

  6. OS

    Overall survival

    Measured: from the date of first dose until the date of death from any cause， assessed up to 2 years

  7. DOR

    Duration of response

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2020
  2. Study start8 Jul 2020
  3. Primary completionDec 2022 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04326829
Sponsor's protocol ID
QL1604-201
Status last verified
Nov 2022
First submitted
26 Mar 2020
Last updated
7 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39529169

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1604 in people with Advanced Malignant Tumor, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shunjiang Yu, CMO (0531-83129659, shunjiang.yu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04326829, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.

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