Advanced Solid TumorPhase 1NCT04825392
A Phase Ib Study of HX008 in Patients With Advanced Solid Tumors
A Phase 1 study testing HX008 in people with Advanced Solid Tumor, run by Taizhou Hanzhong biomedical co. LTD at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- 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
- 30 participants
- Where
- 3 sitesChina
- Study dates
- 5 Sep 2019to 30 Dec 2021
- Phase
- Phase 1
- 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 years and older
- 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 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;
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- 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:
- 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;
- Renal function: Serum creatinine (Scr) ≤1.5×ULN;
- 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;
- 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.
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 nonautoimmune allergic diseases;
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- 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.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Hunan Cancer Hospital
Changsha
Nong Yang, yangnongpi@163.com
- Recruiting
Hunan Cancer Hospital
Changsha
Shanzhi Gu, 105575191@qq.com
- Recruiting
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan
Xiaorong Dong, 13986252286@139.com
About this study
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
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.
- Conditions
- Advanced Solid Tumor
- Being tested
- HX008
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 group | Role | What they receive |
|---|---|---|
| HX008 | Experimental | Not described Receives: Drug: HX008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 24 months
Secondary outcomes (5)
Objective Response Rate (ORR)
Measured: 24 months
Disease Control Rate (DCR)
Measured: 24 months
Duration of Response (DOR)
Measured: 24 months
Progress Free Survival (PFS)
Measured: 24 months
Overall Survival (OS)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start5 Sep 2019
- Primary completion30 May 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hanzhong biomedical co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825392
- Sponsor's protocol ID
- HX008-Ib-01
- Status last verified
- Mar 2021
- First submitted
- 28 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04825392
- Acronym / sponsor ID
- HX008-Ib-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taizhou Hanzhong biomedical co. LTDIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HX008 | Experimental | Drug: HX008 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HX008Patients will receive HX008 3mg/kg by intravenous (IV) infusion on Day 1, every 3 weeks (Q3W), till progressed disease or withdrawal. | Drug | HX008 |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 24 months
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: 24 months
Disease Control Rate (DCR)
Time frame: 24 months
Duration of Response (DOR)
Time frame: 24 months
Progress Free Survival (PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HX008 in people with Advanced Solid Tumor, run by Taizhou Hanzhong biomedical co. LTD at 3 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 14 inclusion and 19 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Nong Yang (130 5519 3557, yangnongpi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2021.