AzTrials
AzTrials

MelanomaPhase 2NCT04749485

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

A Phase 2 study testing HX008 in people with Melanoma, run by Taizhou Hanzhong biomedical co. LTD at 11 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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Melanoma
What is being tested?
HX008
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
11 sitesChina
Study dates
8 Nov 2018to 8 Nov 2021
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

  • 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.
Show all 11Show fewer
  • 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);
  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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);
  • Has participated in other clinical trial within 4 weeks prior to the first dose of the study drug.
  • Alcohol dependence or drug abuse within recent one year.
  • Has a history of confirmed neurological or mental disorders, such as epilepsy, dementia; or with poor compliance; or the presence of peripheral neurological disorders.
  • Has brain metastasis with symptoms.
  • Is pregnant or breastfeeding.
  • Other reasons disqualifying the entering of this study based on the evaluation of the investigators.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

China11 sites

  • Peking University Cancer Hospital and Research Institute

    Beijing, Beijing Municipality

  • The first Hospital of Jilin University

    Changchun, Jilin

  • West China Hospital Sichuan Universtiy

    Chengdu, Sichuan

  • Fujian Cancer Hospital

    Fuzhou, Fujian

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • Zhejiang University School of Medicine Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Fudan Universtiy Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: 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.

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.

Conditions
Melanoma
Being tested
HX008
Medical subject headings
Melanoma

What participants receive

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

  • HX008Drug

    Patients will receive HX008 3mg/kg by intravenous (IV) infusion on Day 1, every 3 weeks (Q3W), till progressed disease or withdrawal.

Study groups in NCT04749485
Study groupRoleWhat they receive
HX008ExperimentalNot described
Receives: Drug: HX008

What is being measured

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

  1. Objective Response Rate (ORR)

    Percentage of subjects achieving complete response (CR) and partial response (PR).

    Measured: 24 months

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: 36 months

Secondary outcomes (3)

  1. Progression-Free Survival (PFS)

    Progression-free survival (PFS) is defined as the time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.

    Measured: 24 months

  2. Duration of Response (DOR)

    Duration of Response (DOR) is defined as the time from the first evidence of response (PR or CR) to the first evidence of PD or the date of death for any reason.

    Measured: 24 months

  3. Overall survival (OS)

    Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause.

    Measured: 36 months

Timeline

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

  1. First posted11 Feb 2021
  2. Study start8 Nov 2018
  3. Primary completion19 Aug 2020
  4. Study completion8 Nov 2021 (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
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04749485
Sponsor's protocol ID
HX008-II-MM-01
Status last verified
Feb 2021
First submitted
7 Feb 2021
Last updated
11 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cui C, Chen Y, Luo Z, Zou Z, Jiang Y, Pan H, Fan Q, Zhao J, Xu Q, Jiang R, Wang X, Ma T, Guo Z, Si L, Chi Z, Sheng X, Dou Y, Tan Q, Wu D, Guo J. Safety and efficacy of Pucotenlimab (HX008) - a humanized immunoglobulin G4 monoclonal antibody in patients with locally advanced or metastatic melanoma: a single-arm, multicenter, phase II study. BMC Cancer. 2023 Feb 6;23(1):121. doi: 10.1186/s12885-022-10473-y.

    PubMed 36747118

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HX008 in people with Melanoma, run by Taizhou Hanzhong biomedical co. LTD at 11 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 16 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 24 months). The study lists 2 primary outcomes in all. 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 NCT04749485, 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 11 Feb 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in