Advanced Solid TumorPhase 2NCT04886271
Recombinant Humanized Anti-CD47 / PD-1 Bifunctional Antibody HX009 Injection in the Treatment of Advanced Solid Tumors
A Phase 2 study testing HX009 in people with Advanced Solid Tumor, run by Hangzhou Hanx Biopharmaceuticals, Ltd. at 1 site in China.
Trial summary
This is a multi-center phase II clinical trial to evaluate the anti-tumor activity and safety of HX009 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- HX009
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2021to 22 Feb 2024
- 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
- Male or female, aged 18 to 75 years, inclusive;
- Eastern Cooperative Oncology Group performance status of 0 to 1;
- Having unresectable locally advanced or metastatic solid tumor (confirmed by histology and cytology);
- Participants must have failed the standard treatment (due to either disease progression or intolerable toxicity) or the standard of care had not been established for the specific condition;
- Measurable extracranial lesion based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1;
- Life expectancy ≥12 weeks;
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- For prior anti-tumor therapies, the following conditions must be met:
- The interval between local radiotherapy or radiotherapy for bone metastasis and the first dose is ≥2 weeks;
- The interval between the last dose of previous chemotherapy, immunotherapy (including PD-1, PD-L1 or CTLA-4 antibodies), biological therapy (tumor vaccines, cytokines, or anti-cancer growth factors) and the first dose of HX009 is ≥4 weeks (The interval between the last dose of small molecule targeted drugs and the first dose of HX009 is ≥2 weeks);
- The interval between the last dose of anti-cancer Traditional Chinese Medicine and the first dose of HX009 is ≥ 2 weeks;
- Has had previously serious adverse reactions (pneumonia or myocarditis) related to previous PD1/PDL1or CTLA-4 inhibitors that preclude their treatment according to the investigator's criteria;mmune-related adverse reactions must be restored to Grade 1 except for adverse endocrine system reactions;
- Participants with asymptomatic central nervous system (CNS) metastases are eligible only if they have no evidence of progression by imaging for at least 12 weeks prior to the first dose of HX009 and are not using corticosteroids;
- Appropriate organ functions according to the following laboratory tests :
- Absolute neutrophil count (ANC)≥1.5 × 10^9/L
- Absolute white blood cell count (WBC) ≥3.0×10^9/L
- Platelet count ≥90 × 10^9/L
- Hemoglobin ≥90 g/L
- Serum creatinine≤1.5 upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN , ALT and AST ≤5 × ULN for subjects with liver metastases or liver cancer
- Serum Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN)
- International normalized ratio (INR) ≤ 2 x ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN (except for patients receiving anticoagulant therapy) ;
- Reproductive males or females who are likely to become pregnant must use highly effective contraceptive methods (such as oral contraceptives, intrauterine contraceptives, sexual control or barrier contraceptives combined with spermicides) during the trial, and continue contraception for 6 months after the last dose of HX009;
- Participants must be willing and able to provide written informed consent for the study, and have good compliance;
Who cannot join
- Participants having a known additional malignancy within 5 years before enrollment, except for malignancies with low risk of metastasis and death (5-year survival rate> 90%), such as completely resected basal cell or squamous cell skin cancer, or cervical carcinoma in situ, or superficial bladder cancer,early breast cancer with low risk of recurrence, etc;
- Adverse reactions related to previous treatment that failed to recover to CTCAE 5.0 ≤ grade 1 (chemotherapy-induced alopecia or grade 2-3 peripheral neurotoxicity are eligible; immune-related grade 2-3 hypothyroidism is eligible)；
- Participants with active or history of autoimmune diseases are ineligible, except for the following conditions:
- Participants with type 1 diabetes who are in stable condition after using a fixed dose of insulin;
- Autoimmune hypothyroidism requiring only hormone replacement therapy;
- Autoimmune skin diseases that do not require systemic treatment (such as eczema, skin rashes that account for less than 10% of the body surface, or psoriasis without ophthalmological symptoms);
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- Participants expected to undergo major surgery within 28 days before the planned first dose of HX009;
- Participants receiving systemic corticosteroids equivalent to >10 mg prednisone/day or other immunosuppressive drugs within 14 days before the first administration of HX009, except for the following conditions:
- Participants using topical or inhaled corticosteroids;
- Short-term (≤7 days) use of glucocorticoids equivalent to ≤10 mg of prednisone daily for the prevention or treatment of non-autoimmune allergic diseases is permitted;
- Participants with known interstitial lung disease or non-infectious pneumonia requiring systemic treatment with glucocorticoids;
- Participants having clinically serious cardiovascular diseases (unstable angina or myocardial infarction within 6 months before enrollment), diabetes, or hypertension;
- Participants having a history of human immunodeficiency virus infection, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;
- Patients with active chronic hepatitis B or active hepatitis C. Hepatitis B virus carriers, stable hepatitis B after drug treatment (DNA titer not higher than 500 IU/mL or copy number <1000 copies/ml) and cured hepatitis C patients (HCV RNA test negative) can be enrolled;
- Participants having a serious infection within 4 weeks before the first administration of HX009, or having an active infection that require oral or intravenous antibiotic treatment;
- Participants having severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, or to any drug component of HX009 (CTCAE 5.0 grade greater than 3);
- Participated in other drug clinical trials within 4 weeks before the first administration of HX009;
- Alcohol dependent or known history of drug abuse within the past year;
- Participants with poor compliance due to known history of neurological or mental disorders, such as epilepsy, dementia;
- Pregnant or breastfeeding women;
- Participants with pleural effusion, abdominal effusion or pericardial effusion with clinical symptoms;
- Those who have received blood transfusion therapy within 4 weeks before the start of treatment or received hematopoietic stimulating factor therapy within 2 weeks, such as colony stimulating factor, erythropoietin, thrombopoietin, etc.;
- According to the investigator's judgment, the subjects have other factors that may cause them to be forced to terminate the study halfway, such as serious diseases requiring concomitant treatment, family or social factors, which may affect the safety of the subjects or the collection of experimental data.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong
About this study
Official title: A Multicenter Phase II Clinical Study of Recombinant Humanized Anti-CD47 / PD-1 Bifunctional Antibody HX009 Injection in the Treatment of Advanced Solid Tumors
This is a multi-center phase II clinical trial to evaluate the anti-tumor activity and safety of HX009 in subjects with advanced solid tumors.
Read the detailed description
The present study is comprised of two parts: the efficacy estimation part and the key phase II part. In the first part, subjects with unresectable locally advanced or metastatic solid tumors (confirmed by histology or pathology) will be enrolled. Tumor types of special interest include biliary cancers, head and neck cancers, esophageal cancers, sarcoma, and malignant mesothelioma, and at least 8 subjects will be enrolled for each of these tumor types. Subjects with biliary cancers and other tumor types based on the efficacy data of the first part will be enrolled in the second part of the study.
Subjects will receive HX009 via intravenous infusion at 5 mg/Kg once every 2 weeks. Treatment will continue until loss of clinical benefit at the discretion of the investigator, or intolerable toxicity, or withdrawal of consent, or disease progression, or death, or loss of follow-up (whichever occurs first). The maximum duration of treatment with HX009 is one year.
Tumor evaluation is conducted by the investigator according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and immune RECIST (iRECIST), and is repeated every 6 weeks. Adverse events (AEs) are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).
- Conditions
- Advanced Solid Tumor
- Being tested
- HX009
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX009Drug
Eligible participants will receive HX009 treatment at 5mg/Kg via IV infusion over 60-120 minutes, and the scheduled dosing cycle is once every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HX009 | Experimental | Not described Receives: Drug: HX009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) of patients with solid tumors treated with HX009 assessed by the Independent Review Committee (IRC)
The ORR is defined as the percentage of participants in the analysis population who had a confirmed Complete Response or Partial Response using RECIST 1.1 criteria.
Measured: Approximately 1 year
Secondary outcomes (14)
Objective response rate(ORR) of patients with solid tumors treated with HX009 per Investigator Assessment
The ORR is defined as the percentage of participants in the analysis population who had a confirmed Complete Response or Partial Response using RECIST 1.1 criteria.
Measured: Approximately 1 year
Duration of response (DoR) of patients with solid tumors treated with HX009
The DoR is defined as the time from the first recorded response (CR or PR) to the first recorded tumor progression or death due to any cause.
Measured: Approximately 1 year
Disease control rate (DCR) of patients with solid tumors treated with HX009
The DCR is defined as the percentage of participants in the analysis population who had a confirmed Complete Response, or Partial Response, or Stable Disease using RECIST 1.1 criteria.
Measured: Approximately 1 year
Progression-free survival (PFS) of patients with solid tumors treated with HX009
PFS is defined as the time from the start of the first dose and the first documented disease progression using RECIST 1.1 criteria or death of any cause.
Measured: Approximately 1 year
Overall survival (OS) of patients with solid tumors treated with HX009
OS is defined as the time between the start of the first dose and death of any cause.
Measured: Approximately 1 year
Incidence of treatment-related adverse events in patients with advanced solid tumors treated with HX009
Adverse events (AEs) related to HX009 as determined by the investigator are recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0).
Measured: AEs will be collected from the start of the study treatment up to 90 days after the last dose.
Severity of treatment-related adverse events in patients with advanced solid tumors treated with HX009
Adverse events (AEs) related to HX009 as determined by the investigator are recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0).
Measured: AEs will be collected from the start of the study treatment up to 90 days after the last dose.
Number of patients having detectable anti-drug antibody (ADA) of HX009
Detection of ADA is a measure of immunogenicity of HX009
Measured: Approximately 1 year
Number of patients having detectable neutralizing antibody (Nab) of HX009
Detection of Nab is a measure of immunogenicity of HX009
Measured: Approximately 1 year
Elimination half-life (t1/2β) of HX009 in patients with advanced solid tumors
Key pharmacokinetic parameter
Measured: Approximately 1 year
Mean residence time in the body (MRT) of HX009 in patients with advanced solid tumors
Key pharmacokinetic parameter
Measured: Approximately 1 year
Area under the concentration-time curve (AUC0-t) of HX009 in patients with advanced solid tumors
Key pharmacokinetic parameter
Measured: Approximately 1 year
Peak plasma concentration (Cmax) of HX009 in patients with advanced solid tumors
Key pharmacokinetic parameter
Measured: Approximately 1 year
Time to peak plasma concentration (Tmax) of HX009 in patients with advanced solid tumors
Key pharmacokinetic parameter
Measured: Approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start12 May 2021
- Primary completion12 Jan 2024
- Study completion22 Feb 2024
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jing Huang, MD, Principal investigator, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886271
- Sponsor's protocol ID
- HX009-II-01
- Status last verified
- Apr 2026
- First submitted
- 5 May 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Clinical Study of Recombinant Humanized Anti-CD47 / PD-1 Bifunctional Antibody HX009 Injection in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04886271
- Acronym / sponsor ID
- HX009-II-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 May 2021 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 14 May 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.
This is a multi-center phase II clinical trial to evaluate the anti-tumor activity and safety of HX009 in subjects with advanced solid tumors.
Detailed description
The present study is comprised of two parts: the efficacy estimation part and the key phase II part. In the first part, subjects with unresectable locally advanced or metastatic solid tumors (confirmed by histology or pathology) will be enrolled. Tumor types of special interest include biliary cancers, head and neck cancers, esophageal cancers, sarcoma, and malignant mesothelioma, and at least 8 subjects will be enrolled for each of these tumor types. Subjects with biliary cancers and other tumor types based on the efficacy data of the first part will be enrolled in the second part of the study.
Subjects will receive HX009 via intravenous infusion at 5 mg/Kg once every 2 weeks. Treatment will continue until loss of clinical benefit at the discretion of the investigator, or intolerable toxicity, or withdrawal of consent, or disease progression, or death, or loss of follow-up (whichever occurs first). The maximum duration of treatment with HX009 is one year.
Tumor evaluation is conducted by the investigator according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and immune RECIST (iRECIST), and is repeated every 6 weeks. Adverse events (AEs) are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HX009 | Experimental | Drug: HX009 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female, aged 18 to 75 years, inclusive;
- Eastern Cooperative Oncology Group performance status of 0 to 1;
- Having unresectable locally advanced or metastatic solid tumor (confirmed by histology and cytology);
- Participants must have failed the standard treatment (due to either disease progression or intolerable toxicity) or the standard of care had not been established for the specific condition;
- Measurable extracranial lesion based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1;
Key exclusion criteria (23 listed)
- Participants having a known additional malignancy within 5 years before enrollment, except for malignancies with low risk of metastasis and death (5-year survival rate> 90%), such as completely resected basal cell or squamous cell skin cancer, or cervical carcinoma in situ, or superficial bladder cancer,early breast cancer with low risk of recurrence, etc;
- Adverse reactions related to previous treatment that failed to recover to CTCAE 5.0 ≤ grade 1 (chemotherapy-induced alopecia or grade 2-3 peripheral neurotoxicity are eligible; immune-related grade 2-3 hypothyroidism is eligible)；
- Participants with active or history of autoimmune diseases are ineligible, except for the following conditions:
- Participants expected to undergo major surgery within 28 days before the planned first dose of HX009;
- Participants receiving systemic corticosteroids equivalent to >10 mg prednisone/day or other immunosuppressive drugs within 14 days before the first administration of HX009, except for the following conditions:
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 |
|---|---|---|
| HX009Eligible participants will receive HX009 treatment at 5mg/Kg via IV infusion over 60-120 minutes, and the scheduled dosing cycle is once every 2 weeks. | Drug | HX009 |
Primary outcome
Objective response rate (ORR) of patients with solid tumors treated with HX009 assessed by the Independent Review Committee (IRC)
Time frame: Approximately 1 year
The ORR is defined as the percentage of participants in the analysis population who had a confirmed Complete Response or Partial Response using RECIST 1.1 criteria.
14 secondary outcomes
Objective response rate(ORR) of patients with solid tumors treated with HX009 per Investigator Assessment
Time frame: Approximately 1 year
Duration of response (DoR) of patients with solid tumors treated with HX009
Time frame: Approximately 1 year
Disease control rate (DCR) of patients with solid tumors treated with HX009
Time frame: Approximately 1 year
Progression-free survival (PFS) of patients with solid tumors treated with HX009
Time frame: Approximately 1 year
Overall survival (OS) of patients with solid tumors treated with HX009
Time frame: Approximately 1 year
Incidence of treatment-related adverse events in patients with advanced solid tumors treated with HX009
Time frame: AEs will be collected from the start of the study treatment up to 90 days after the last dose.
Severity of treatment-related adverse events in patients with advanced solid tumors treated with HX009
Time frame: AEs will be collected from the start of the study treatment up to 90 days after the last dose.
Number of patients having detectable anti-drug antibody (ADA) of HX009
Time frame: Approximately 1 year
Number of patients having detectable neutralizing antibody (Nab) of HX009
Time frame: Approximately 1 year
Elimination half-life (t1/2β) of HX009 in patients with advanced solid tumors
Time frame: Approximately 1 year
Mean residence time in the body (MRT) of HX009 in patients with advanced solid tumors
Time frame: Approximately 1 year
Area under the concentration-time curve (AUC0-t) of HX009 in patients with advanced solid tumors
Time frame: Approximately 1 year
Peak plasma concentration (Cmax) of HX009 in patients with advanced solid tumors
Time frame: Approximately 1 year
Time to peak plasma concentration (Tmax) of HX009 in patients with advanced solid tumors
Time frame: Approximately 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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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.
Jing Huang, MD principal investigator
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HX009 in people with Advanced Solid Tumor, run by Hangzhou Hanx Biopharmaceuticals, Ltd. at 1 site 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 23 inclusion and 23 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: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) of patients with solid tumors treated with HX009 assessed by the Independent Review Committee (IRC) (time frame: Approximately 1 year). 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 15 Apr 2026.