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MSI-H Solid Malignant TumorPhase 2NCT03941574

A Clinical Study to Evaluate HLX10 Monotherapy for the Treatment of MSI-H or dMMR Solid Tumors That Failed to Respond to Standard Therapy

A Phase 2 study testing HLX10 in people with MSI-H Solid Malignant Tumor, run by Shanghai Henlius Biotech at 33 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

It is a single-arm, open-label, multicenter, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 monotherapy for the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors who have progressed or intolerable after standard therapy.This study consists of three periods… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
MSI-H Solid Malignant Tumor
What is being tested?
HLX10
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
33 sitesChina
Study dates
15 Jul 2019to 30 Jun 2026
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects who meet all of the following criteria are allowed to be enrolled into this study:
  • Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
  • Age ≥ 18 years and ≤ 75 years when ICF is signed;
  • Patients with unresectable or metastatic MSI-H or dMMR malignant solid tumors which are histopathologically or/and cytologically confirmed by the central laboratory or study sites;
  • Patients who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received;
  • The interval between the end of previous systemic anti-tumor treatment and the first dosing of if this study must be ≥ 2 weeks. In addition, treatment-related AEs recover to NCI-CTCAE v4.03 ≤ grade 1 (excluding grade 2 alopecia).
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  • There is at least one measurable lesion assessed by IRRC according to the requirements of RECIST version 1.1 (Appendix 1).
  • Note: measurable lesions cannot be selected from the previous radiotherapy sites. If the target lesion of the previous radiotherapy sites is the only one available lesion, the investigator is required to provide imaging data before and after significant progression of such lesion.
  • Subjects must provide tumor tissues and blood samples for the determination of MSI, tumor mutational burden (TMB), PD-L1 expression level (if the test results of the above parameters by the central laboratory specified by this study are available, the subjects are allowed not to receive repeated tests).
  • Note: it is recommended to provide formalin fixed tumor tissue samples collected from non-radiotherapy sites within 6 months prior to the first dosing of investigational product, paraffin embedded tumor samples (preferred), or formalin fixed paraffin embedded tumor samples or unstained newly sliced serial sections (glass slides). Moreover, the corresponding pathological reports of the above samples must also be provided. Freshly collected samples, excision, core needle biopsy, resection, incision, punching or forceps biopsies are within the acceptable range (newly-obtained tissues preferred). The aspiration samples (i.e., lack of complete tissue structure and only cell suspension and/or cell smears are provided), brushing samples, cell precipitation samples from pleural or peritoneal effusion are not acceptable. The requirements for tissue samples are provided in laboratory operating manual in detail.
  • ECOG performance status score (Appendix II) of 0 or 1 within 7 days before the first dose of invetigational product;
  • Life expectancy ≥12 weeks;
  • Negative HBsAg; patients with positive HBsAg or HBcAb test results can be enrolled only if Hepatitis B virus (HBV) DNA test results are negative.
  • 11.Negative HCV antibody; patients with positive HCV antibody or HCV-RNA test results can be enrolled only if ALT and AST are CTCAE v4.03 ≤ grade 1 (i.e., ≤ 3×ULN); subjects concurrently infected with hepatitis B and hepatitis C are excluded.
  • Normal function of main organs, and the following criteria are met (within the 14 days before the first injection of investigational product, patients have not received the treatment with blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor (CSF)):
  • Female subjects must meet the following criteria:
  • ① Menopause (defined as no menstruation for at least one year, and no other confirmed reasons other than menopause), or② Received surgical sterilization (ovariectomy and/or hysterectomy), or③ Subjects who are able to bear or father a child must meet the following criteria:
  • Serum pregnancy test must be negative within 7 days before the first dosing, and
  • Agree to use contraceptive methods with an annual failure rate of < 1% or maintain sexual abstinence (avoid heterosexual intercourse) (from the signing of informed consent form to at least 120 days after the last dose of investigational product) (contraceptive methods with an annual failure rate of < 1% include bilateral tubal ligation, male sterilization, correct use of hormonal contraceptives which may inhibit ovulation, hormone-releasing intrauterine device and copper intrauterine device), and
  • Breast-feeding is not allowed.
  • Male subjects should meet the criteria below: agree to maintain sexual abstinence (avoid heterosexual intercourse) or use contraceptive methods, with requirements detailed below: if the partners of male subjects have childbearing potential or become pregnant, male subjects must maintain sexual abstinence or use condoms to prevent drug exposure to embryos during administration period of investigational product and within at least 120 days after after the last dose of investigational product. The reliability of sexual abstinence should be evaluated based on the duration of clinical studies, preference of the subjects and daily life style. Regular sexual abstinence (e.g., calendar days, ovulation period, basal body temperature or post-ovulation period contraceptive methods) and coitus interruptus are disqualified contraceptive methods.

Who cannot join

  • Subjects who meet any of the following criteria are not allowed to be enrolled in this study:
  • Subjects who plan to undergo or previously underwent organ or bone marrow transplantation.
  • Uncontrollable pleural effusion, pericardial effusion or ascites after appropriate intervention measures.
  • Subjects with known or screening test-confirmed active central nervous system (CNS) metastasis and/or carcinomatous meningitis; However, the following subjects are allowed to be enrolled: 1. subjects with asymptomatic brain metastasis (i.e. without progressive central nervous system symptoms caused by brain metastatic lesions, without the requirement of corticosteroids treatment, and lesion size ≤1.5cm) are allowed to participate in this study, however, it is necessary to perform regular brain imaging tests for disease sites. 2. subjects with brain metastasis after treatment, and brain metastatic lesions are stable for at least 1 month, without evidence of new or expanded brain metastasis, and steroids are discontinued 3 days prior to the first dose of the investigational product. Stable brain metastasis in this definition should be confirmed before the first dose of the investigational product.
  • Subjects with spinal cord compression which cannot be radically treated through surgery and/or radiotherapy, or subjects previously diagnosed with spinal cord compression with no post-treatment clinical evidence showing stable disease ≥ 1 week before the first dose of the investigational product.
  • Imaging test results show definit tumor invasion of thoracic great vessels.
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  • Occurrence of myocardial ischemia above grade Ⅱ , or myocardial infarction, unstable angina pectoris, inadequately controlled arrhythmia (including QTc interval ≥ 450 ms for males, and ≥ 470 ms for females) within half a year before the first dose of the investigational product (QTc interval is calculated based on Fridericia formula).
  • Grade Ⅲ or Ⅳ cardiac dysfunction based on New York Heart Association (NYHA) Functional Classification (appendix Ⅲ) or echocardiography test showing left ventricular ejection fraction (LVEF) < 50%.
  • Presence of peripheral neuropathy with CTCAE v4.03 ≥ grade 2.
  • Infection with human immunodeficiency virus (HIV).
  • Presence of active pulmonary tuberculosis.
  • Previously or currently suffering from interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, seriously injured lung function and other conditions which may interfere with the detection and treatment of suspected drug-related pulmonary toxicity.
  • Presence of know active or suspected autoimmune diseases; Patients who have stable status and require no treatment with systemic immunosuppressive therapies are allowed to be enrolled.
  • Treatment with live vaccines within 28 days before the first administration of investigational product.
  • Subjects requiring treatment with systemic corticosteroids (> 10 mg/day prednisone or equivalent dose of similar drugs) or other immunosuppressive therapies within 14 days before the first administration of investigational product or during the study period; However, the following conditions are allowed to be enrolled: in the event of no active autoimmune diseases, inhalation or topical use of steroids or adrenaline alternative treatment of effective dose of prednisone ≤ 10 mg/day are allowed.
  • Presence of any active infection requiring systemic anti-infection treatment within 14 days before the first administration of investigational product.
  • Subjects who have received major surgery within 28 days before the first administration of investigational product, by "major surgery", it meant that the patient needs at least three weeks to recover following the surgery before being able to receive the study treatment. Enrollment through tumor puncture or lymph node biopsy is allowed.
  • Received radical radiotherapy within 3 months before the first administration of investigational product.
  • Note: palliative radiotherapies for bones or superficial lesions are acceptable. The course of treatment should be in accordance with the local standard and has ended 14 days before the first administration. Radiotherapy covering more than 30% of the bone marrow area is not allowed within 28 days prior to the first dose.
  • Other anti-tumor treatments such as chemotherapy, targeted therapy or radiotherapy (excluding palliative radiotherapy) may be received during the study period.
  • Previously received treatment with any T cells costimulation or immune checkpoint, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other targeted T cells drugs.
  • Subjects are participating in other clinical studies, or the time interval between the initiation of treatment planned in this study and end of investigational product treatment in the previous clinical study is less than 14 days.
  • Known serious hypersensitivity history to any monoclonal antibody or the excipients of investigational product.
  • Pregnant or lactating women.
  • Known history of abuse of psychotropic drugs or drug addiction; Subjects who have stopped drinking are allowed to be enrolled.
  • The subjects have other factors which may cause premature termination of this study at the discretion of the investigators.

Trial locations and contacts

33 sites in 1 country.

ShuKui Qin contact

86-025-80864362

luolinhua0513@163.com

33 sites in 1 country

China33 sites, 33 recruiting

  • Peking University International Hospital

    Beijing, Beijing Municipality, 102206

    Jun Liang

    Recruiting

  • The Third Xiangya Hospital, Central South University

    Changsha, Hunan, 410013

    Peiguo Cao

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

    Xianli Yin

    Recruiting

  • Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China

    Chengdu, Sichuan, 610041

    Yongdong Jin

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Qing Zhu

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

    Tao Zhang

    Recruiting

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

    Yang Zhang

    Recruiting

  • First People's Hospital of Fushan

    Fushan, Guangdong, 528010

    Wei Wang

    Recruiting

  • the 900th Hospital of Joint Logistic Support Force

    Fuzhou, Fujian, 35002

    Xi Chen

    Recruiting

  • The First Affiliated Hospital and Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510075

    Shirong Cai

    Recruiting

  • The First Affiliated Hospital (School of Clinical Medicine), Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510080

    Xicheng Wang

    Recruiting

  • Affiliated Cancer Hospital & Institute, Guangzhou Medical University

    Guangzhou, Guangdong, 510095

    Chuan Jin

    Recruiting

  • the Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Yanhong Deng

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Haijun Zhong

    Recruiting

  • Harbin Medical University Cancer Hospital,

    Harbin, Heilongjiang, 150040

    Yuxian Bai

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

    Zhendong Chen

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Xiuwen Wang

    Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Changzheng Li

    Recruiting

  • Yunnan Cancer Hospital/The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Center

    Kunming, Yunnan, 650118

    Yunfeng Li

    Recruiting

  • Qinhuai Medical District, General Hospital of the eastern theater of the Chinese people's Liberation Army

    Nanjing, Jiangsu, 210002

    Linhua Luo, 86-025-80864362, luolinhua0513@163.com

    Shukui Qin

    Recruiting

  • The People's Hospital of Guangxi Zhuangzu Autonomous Region

    Nanning, Guangxi, 530016

    Kehe Chen

    Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

    Jin Li

    Recruiting

  • Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042

    Jingdong Zhang

    Recruiting

  • Fourth Hospital of Hebei Medical University,

    Shijiazhuang, Hebei, 050011

    Da Jiang

    Recruiting

  • Taizhou first people's Hospital

    Taizhou, Zhejiang, 318020

    Lili Chen

    Recruiting

  • Tianjin Medical University Cancer Institue and Hospital

    Tianjin, Tianjin Municipality, 300060

    Xiubao Ren

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Fujian, 430062

    Fuxiang Zhou

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 200065

    Xianglin Yuan

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Huangyang Ye

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Qingxia Fan

    Recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhenjiang, Guangdong, 510180

    Zhong Xie

    Recruiting

  • Zhongshan city People's Hospital

    Zhongshan, Guangdong, 528404

    Jianjun Xiao

    Recruiting

  • The Fifth Affiliated Hospital, Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Hongyu Zhang

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Multi-center, Phase Ⅱ Clinical Study to Evaluate the HLX10 Monotherapy for the Treatment of Unresectable or Metastatic Microsatellite Instability-high (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors That Failed to Respond to Standard Therapy

It is a single-arm, open-label, multicenter, phase II clinical study to evaluate the clinical efficacy and safety of HLX10 monotherapy for the treatment of patients with unresectable or metastatic MSI-H or dMMR solid tumors who have progressed or intolerable after standard therapy.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria. The enrolled subjects will receive an intravenous infusion of HLX10 (3 mg/kg) once every 2 weeks until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent or other reasons as specified in the protocol, or up to the longest treatment duration-2 years (52 dosing periods) (whichever occurs earlier).

Being tested
HLX10

What participants receive

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

  • HLX10Drug

    HLX10 developed by our company is sterile intravenous injection, with specification of 100 mg/10 mL/bottle. The main ingredient is 10.0 mg/mL of recombinant humanized anti-PD-1 monoclonal antibody. The excipients include 0.95 mg/mL citric acid (citric acid monohydrate), 4.56 mg/mL sodium citrate (sodium citrate dihydrate), 3.0 mg/mL sodium chloride, 30.0 mg/mL mannitol and 0.20 mg/mL polysorbate 80 (tween 80), with pH of 5.5.

Study groups in NCT03941574
Study groupRoleWhat they receive
HLX10ExperimentalNot described
Receives: Drug: HLX10

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) based on the RECIST Version 1.1)

    Measured: up to 2 years

Secondary outcomes (8)

  1. ORR

    Objective response rate (assessed by the investigators based on the RECIST Version 1.1)

    Measured: up to 2 years

  2. ORR

    Objective response rate (assessed by independent radiological review committee (IRRC) based on the iRECIST)

    Measured: up to 2 years

  3. 6-month OS rate

    6-month overall survival rate

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

  4. OS

    Overall survival (OS)

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

  5. 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

  6. PFS

    Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1, iRECIST)

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

  7. PFS

    Progression-free survival (assessed by the investigators based on RECIST v1.1)

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

  8. DOR 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 posted8 May 2019
  2. Study start15 Jul 2019
  3. Primary completion30 May 2024 (estimated)
  4. Study completion30 Jun 2026 (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
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941574
Sponsor's protocol ID
HLX10-010-MSI201
Status last verified
Oct 2022
First submitted
24 Apr 2019
Last updated
28 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shukui Qin, Jin Li, Haijun Zhong, et al. Efficacy and safety of HLX10, a novel anti-PD-1 antibody, in patients with previously treated unresectable or metastatic microsatellite instability-high or mismatch repair-deficient solid tumors: A single-arm, multicenter, phase 2 study. Journal of Clinical Oncology 2021 39:15_suppl, 2566-2566

  • Qin S, Li J, Zhong H, Jin C, Chen L, Yuan X, Fan Q, Chen K, Cao P, Xiao J, Jiang D, Zhang T, Zhang H, Wang X, Wang W, Han L, Wang Q, Zhu J; Serplulimab-MSI-H Investigators. Serplulimab, a novel anti-PD-1 antibody, in patients with microsatellite instability-high solid tumours: an open-label, single-arm, multicentre, phase II trial. Br J Cancer. 2022 Dec;127(12):2241-2248. doi: 10.1038/s41416-022-02001-3. Epub 2022 Oct 19.

    PubMed 36261583

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HLX10 in people with MSI-H Solid Malignant Tumor, run by Shanghai Henlius Biotech at 33 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 21 inclusion and 26 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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 ShuKui Qin (86-025-80864362, luolinhua0513@163.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 NCT03941574, which also lists 2 linked publications.

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 28 Oct 2022.

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