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A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04825392
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Taizhou Hanzhong biomedical co. LTD

Study Description
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Brief Summary:
HX008 is a humanized monoclonal antibody targeting PD-1 on the T cell surface, restores T cell activity, thus enhancing immune response, and has the potential to treat various types of tumors. In this study, the tolerance and safety of HX008 in patients with advanced solid tumors will be evaluated.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: HX008 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study of Tolerance and Safety of a Recombinant Anti-PD-1 Monoclonal Antibody HX008 in Patients With Advanced Solid Tumors
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: HX008 Drug: HX008
Patients will receive HX008 3mg/kg by intravenous (IV) infusion on Day 1, every 3 weeks (Q3W), till progressed disease or withdrawal.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 24 months ]
  2. Disease Control Rate (DCR) [ Time Frame: 24 months ]
  3. Duration of Response (DOR) [ Time Frame: 24 months ]
  4. Progress Free Survival (PFS) [ Time Frame: 24 months ]
  5. Overall Survival (OS) [ Time Frame: 36 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent voluntarily. Understand this protocol and be willing and able to adhere to the study visit schedule;
  • Male and Female aged ≥18 are eligible;
  • Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology, progressed after the failure of standard treatment, or could not accept/have no standard treatment;
  • The patients with ECOG score of 0 or 1;
  • The expected survival time is at least 3 months;
  • Subjects should have measurable lesions (at least one extracranial lesion) According to RECIST v1.1;
  • If the subjects received anti-tumor treatment, they need to meet the following conditions:

The interval between whole-body radiotherapy and the first administration in this study was more than 3 weeks, and the interval between local radiotherapy or radiotherapy for bone metastasis and the first administration was more than 2 weeks. No radiopharmaceuticals were taken within 8 weeks before the first administration. The interval between previous chemotherapy or targeted therapy and the first administration of this trial was ≥ 4 weeks or the interval was ≥ 5 half-lives (whichever occurs first); The interval between immunotherapy or biotherapy (tumor vaccine, cytokine, or growth factor controlling cancer) and the first administration of this study was more than 6 weeks;

  • Has sufficient organ and bone marrow function to meet the following laboratory examination standards:

    1. Blood routine: absolute neutrophil count (ANC)≥1.5×10^9/L; white blood cell count (WBC)≥3×10^9/L; platelet count (PLT)≥100×10^9/ L; hemoglobin (HGB)≥90 g/L;
    2. Renal function: Serum creatinine (Scr) ≤1.5×ULN;
    3. Liver function: TBIL≤1.5×ULN; Patients without liver metastases require alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× ULN. Patients with liver metastases require ALT and AST≤5×ULN;
    4. The coagulation function is adequate, which is defined as the international normalized ratio (INR) ≤ 2×ULN; or activated partial thromboplastin time (APTT)≤ 1.5×ULN;
  • Reproductive men and women of childbearing age are willing to take effective contraceptive measures from signing the informed consent form to 3 months after the last administration of the trial drug.

Exclusion Criteria:

  • Prior malignancy active within the previous 5 years except for locally curable cancers that have been apparently cured, such as carcinoma in situ of the cervix or basal cell skin cancer;
  • With adverse reactions of previous treatment that have not recovered to CTCAE V5.0 grade ≤ 1, except for the residual hair loss effect;
  • Prior treatment with anti-PD-1/PD-L1/CTLA-4 antibody;
  • With active or history of autoimmune diseases that may recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc.), or patients with high risk (e.g., organ transplantation requiring immunosuppressive therapy). While those with the following diseases were allowed to be enrolled: a) Stable patients with type I diabetes after a fixed dose of insulin; b) Autoimmune hypothyroidism requiring hormone replacement therapy only; c) Skin diseases requiring no systemic treatment (e.g. eczema, skin rash covering less than 10% of the body surface, psoriasis without ophthalmic symptoms, etc.);
  • Expecting to receive major surgery during the study period including 4 weeks prior to the first dose of the study drug;
  • Need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone/day) or other immunosuppressive drugs within 14 days before enrollment or during the study period. Those under the following conditions are eligible: a) Locally external use or inhaled corticosteroids; b) short-term (≤ 7 days) use of glucocorticoids for the prevention or treatment of nonautoimmune allergic diseases;
  • Suffered from idiopathic lung disease, interstitial lung disease, pulmonary fibrosis, acute lung disease, etc., except for local interstitial pneumonia induced by radiotherapy;
  • Has uncontrolled systemic diseases, for instance, cardiovascular and cerebrovascular disease, diabetes, tuberculosis;
  • History of human immunodeficiency virus infection, acquired or congenital immunodeficiency disease, organ transplantation, or stem cell transplantation;
  • Patients with symptomatic central nervous system metastasis (patients with asymptomatic central nervous system metastasis or asymptomatic brain metastasis after treatment, without disease progression by CT / MRI examination, and with a time interval of more than 4 weeks from the last radiotherapy are eligible.);
  • Patients with active tuberculosis;
  • Patients with chronic hepatitis B or active hepatitis C. Except for Hepatitis B virus carriers or those with stable hepatitis B after drug treatment with DNA titer no higher than 500 IU/ml or copy number < 1000 copies/ml, and cured hepatitis C patients (HCV RNA test negative);
  • Has severe infection within 4 weeks or active infection requiring IV infusion of antibiotics within 2 weeks prior to the first dose of the study drug;
  • Known to be allergic to macromolecular protein agents or monoclonal antibodies. Known to has a history of severe allergies to any of the components in the study drug (CTCAE v5.0 ≥ grade 3);
  • Has participated in other clinical trials within 4 weeks prior to the first dose of the study drug;
  • Alcohol dependence or drug abuse within the past 1 year;
  • Has a history of confirmed neurological or mental disorders, such as epilepsy, dementia; or poor compliance;
  • Is pregnant or breastfeeding;
  • Other reasons disqualifying the entering of this study based on the evaluation of the investigators.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04825392


Contacts
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Contact: Nong Yang 130 5519 3557 yangnongpi@163.com

Locations
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China
Hunan Cancer Hospital Recruiting
Changsha, China
Contact: Nong Yang       yangnongpi@163.com   
Hunan Cancer Hospital Recruiting
Changsha, China
Contact: Shanzhi Gu       105575191@qq.com   
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Recruiting
Wuhan, China
Contact: Xiaorong Dong       13986252286@139.com   
Sponsors and Collaborators
Taizhou Hanzhong biomedical co. LTD
More Information
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Responsible Party: Taizhou Hanzhong biomedical co. LTD
ClinicalTrials.gov Identifier: NCT04825392    
Other Study ID Numbers: HX008-Ib-01
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms