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UNKNOWNPHASE2

A Study of HX008 for the Treatment of Patients With Malignant Melanoma

A Single-armed Open-labeled Phase II Study of HX008 (a Humanized Monoclonal Antibody Targeting PD-1) for the Treatment of Patients With Locally Advanced or Metastatic Melanoma Who Have Failed the Standard Treatments.

NCT04749485•Taizhou Hanzhong biomedical co. LTD

View on ClinicalTrials.gov

Summary

HX008 is a humanized monoclonal antibody targeting PD-1 on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the efficacy and safety of HX008 in patients with locally advanced or metastatic melanoma who have failed the standard treatments will be evaluated.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 to 75 are eligible;
•Histologic diagnosis of locally advanced unable to undergo complete resection or metastatic melanoma, while ocular melanoma is excluded, and the overall rate of mucosal melanoma is no more than 22%.
•Has failed at least 1 prior routine regimen for advanced disease, including chemotherapy, target therapy, immunotherapy, biological therapy (IFN-gamma, interleukin, onco-vaccine, cytokine, oncolytic virus or cancer growth factor inhibition), and the interval between last previous treatment and the first dose of this trial should be ≥ 4 weeks or 5 half-life of the previously administrated drug, which happens first.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
•Life expectancy ≥ 3 months.
•At least 1 measurable extracranial lesion based on RECIST v1.1, and no prior radiation to measurable lesions;
•Central nervous system metastases must be asymptomatic with or without treatment, and be stable for at least 3 months based on CT/MRI, and no need for systemic steroids within 4 weeks prior to the first dose of the study drug.
•Providing with tumor specimen (for testing the expression of PD -L1);
•Has sufficient organ and bone marrow function to meet the following laboratory examination standards: neutrophils ≥ 1.5 x 10\^9/L; white blood cells ≥3.0 x 10\^9/L; platelets ≥ 100 x 10\^9/L; hemoglobin ≥ 90 g/L; serum creatinine ≤1x ULN; aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; total bilirubin ≤ 1.5 x ULN; INR≤2 x ULN, aPTT≤1.5 x ULN (except for those undergoing anticoagulant therapy);
+1 more criteria

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 non-autoimmune allergic diseases.
•History of human immunodeficiency virus infection, acquired or congenital immunodeficiency disease, organ transplantation or stem cell transplantation.
•Has active chronic HBV or HCV infection, except those with HBV DNA viral load ≤500 IU/mL or \<10\^3 copies/mL, or HCV RNA negative after adequate treatment.
•Has severe infection within 4 weeks or active infection requiring IV infusion or oral administration of antibiotics within 2 weeks prior to the first dose of the study drug.
•Known to be allergic to macromolecular protein agents or monoclonal antibody; Known to has a history of severe allergies to any of the components in the study drug (CTCAE v5.0 ≥ grade 3);
+6 more criteria

Locations (11)

Peking University Cancer Hospital and Research Institute

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The first Hospital of Jilin University

Changchun, Jilin, China

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

West China Hospital Sichuan Universtiy

Chengdu, Sichuan, China

The Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Key Dates

Start Date

November 8, 2018

Primary Completion Date

August 19, 2020

Completion Date

November 8, 2021

Last Updated

February 11, 2021

Enrollment

119

ACTUAL participants

Conditions

Melanoma

Interventions

HX008

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of HX008 for the Treatment of Patients With Malignant Melanoma

Inclusion Criteria

Exclusion Criteria

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