Liver Cancer (Locally Advanced or Metastatic)Phase 1NCT07390838
A Study of SH009 Injection in Patients With Advanced Solid Tumors.
A Phase 1 study testing SH009 in people with Liver Cancer (Locally Advanced or Metastatic) and Lung Cancer (NSCLC), run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.
Trial summary
Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer (Locally Advanced or Metastatic), Lung Cancer (NSCLC), Head and Neck Cancer Squamous Cell Carcinoma
- What is being tested?
- SH009
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2025to 30 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- (1) Age≥18 years old at the time of informed consent, male or female;
- (2) Subjects with histologically confirmed locally advanced, recurrent, or metastatic solid tumors (including but not limited to colorectal cancer, gastric cancer, hepatocellular carcinoma, head and neck cancer, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) who have experienced disease progression or intolerance to at least one prior line of systemic therapy, and for whom no acceptable standard therapy exists or who cannot benefit from or tolerate standard therapy;
- (3) Subjects must have at least one measurable lesion per RECIST 1.1 criteria. A lesion that has been previously irradiated can only be considered measurable if there is documented progression at that site following radiotherapy;
- (4) Archival tumor tissue samples are available, or the subject agrees to undergo a tumor biopsy for the determination of PD-L1 and CD47 expression levels and other biomarker analyses;
- (5) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
- (6) Life expectancy ≥12 weeks;
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- (7) Bone marrow function meets the following criteria: neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 90 × 10^9/L (platelet count ≥ 75 × 10^9/L in patients with liver cancer); hemoglobin (Hb) ≥ 90 g/L;
- (8) Liver function meets the following criteria: total bilirubin(TBIL) ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN for subjects with Gilbert's syndrome); aspartate aminotransferase (AST) and alanine and aminotransferase (ALT) ≤ 3 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver cancer or liver metastases);
- (9) Renal function meets the following criteria: serum creatinine clearance(CLcr) ≥ 50 mL/min (calculated according to Cockcroft-Gault formula); urine dipstick test results show that urine protein < 2 +, urine protein ≥ 2 + subjects should undergo 24-hour urine collection and urine protein content < 1g within 24 hours;
- (10) Coagulation function meets the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5× ULN;
- (11) Female subjects of childbearing potential must use effective contraception during the trial and for 6 months after the last dose, and have a negative pregnancy test within 7 days before treatment initiation (except those who are surgically sterilized or postmenopausal). Male subjects must agree to use effective contraception during the trial and for 6 months after the last dose;
- (12) The subject is fully informed about this trial before its commencement and voluntarily signs and dates the informed consent form.
Who cannot join
- (1) Prior exposure to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein;
- (2) Prior treatment with adoptive cellular therapies such as CAR-T, TCR-T, or TIL. Prior administration of an anti-cancer vaccine, or use of live or live-attenuated vaccines within 4 weeks prior to the first dose;
- (3) Systemic anti-tumor therapies within the specified timeframes prior to the first dose of study drug: Chemotherapy, antibody-based targeted therapy, endocrine therapy, or immunotherapy within 3 weeks. Mitomycin or nitrosoureas within 6 weeks. Oral fluoropyrimidines (e.g., S-1, capecitabine) and small molecule targeted agents within 2 weeks or 5 half-lives of the drug (whichever is longer).Chinese/herbal medicines with anti-cancer activity indicated in their labeling must be discontinued prior to enrollment. Prior radical radiotherapy within 3 months before study drug administration is excluded. Palliative radiotherapy administered within 2 weeks prior to dosing is allowed if the dose meets local palliative care standards and the radiation field covers less than 30% of the bone marrow area;
- (4) Received any investigational drug within 28 days before administration of this trial, or participated in another clinical study at the same time, except for the following circumstances: the patient participated in an observational, non-interventional clinical study, or was in the follow-up period after the end of treatment in an interventional clinical study but the drug withdrawal had exceeded the washout period;
- (5) Had major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first administration, or needed to undergo elective surgery during the trial period;
- (6) Patients who received systemic glucocorticoids (dexamethasone > 10 mg/ day or equivalent dose of the same drug) or other immunosuppressive therapy within 14 days before the first administration; except for topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., prevention of contrast allergy);
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- (7) Symptomatic brain parenchymal or leptomeningeal metastases, deemed by the investigator as unsuitable for enrollment;
- (8) Prior immunotherapy with ≥Grade 3 irAE or ≥Grade 2 immune-related myocarditis;
- (9) Severe or uncontrolled systemic disease, including but not limited to: uncontrolled pleural or peritoneal effusion; uncontrolled diabetes; ventricular arrhythmia requiring intervention; acute coronary syndrome, congestive heart failure, stroke, or other ≥Grade 3 cardiovascular event within 6 months; NYHA Class ≥II or LVEF <50%; clinically significant QTcF prolongation or arrhythmia risk (baseline QTcF >450 msec for males or >470 msec for females); clinically uncontrolled hypertension (SBP >160 mmHg and/or DBP >90 mmHg after treatment) as judged by the investigator. Subjects judged by the investigator as unsuitable due to any such condition;
- (10) History of pneumonia requiring hormone therapy or interstitial lung disease (including past and current history); active pulmonary infection;
- (11) Active infection requiring intravenous anti-infective therapy within 1 week prior to study drug administration (fever attributed to the tumor per investigator's judgment is acceptable). History of self-limited infections that have resolved is acceptable;
- (12) Active Hepatitis B, Hepatitis C, or syphilis infection. Subjects positive for HBeAb or HBsAg are eligible if HBV-DNA ≤200 IU/mL. Subjects positive for HCV-Ab are eligible if HCV-RNA ≤ the upper limit of normal at the research center. Subjects with hepatocellular carcinoma and HBV-DNA ≥2000 IU/mL must receive antiviral/hepatoprotective therapy first and can only enroll after HBV-DNA decreases to <2000 IU/mL;
- (13) History of primary immunodeficiency, including positive human immunodeficiency virus (HIV) test, or suffering from other acquired, congenital immunodeficiency diseases;
- (14) History of other malignancies within 5 years prior to the first dose, except for:
- Any other invasive malignancy, treated with curative intent, with a disease-free interval >3 years and deemed by the investigator not to affect efficacy evaluation for the current tumor. b) Adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or other locally cured cancers;
- (15) History or presence of autoimmune disease within 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis or high risk (e.g., post-transplant immunosuppression). Exceptions: stable type 1 diabetes on fixed-dose insulin; autoimmune hypothyroidism on hormone replacement only; skin conditions not requiring systemic treatment (e.g., eczema, rash covering<10% BSA, psoriasis without ocular symptoms);
- (16) Arterial thromboembolic events within 6 months prior to the first dose, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis, pulmonary embolism, or other serious thromboembolism within 3 months prior to the first dose (catheter-related or superficial venous thrombosis is not considered "serious"). Receiving thrombolytic or anticoagulant therapy for high thrombotic risk;
- (17) Subjects who had receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplant);
- (18) According to CTCAE 5.0, adverse reactions from previous anti-tumor therapy have not yet returned to ≤ grade 1 (except for toxicities which are judged by researchers to be safe, such as hair loss, pigmentation, hypothyroidism stabilized by hormone replacement therapy and peripheral neuropathy (need to recover to ≤ grade 2)). Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the study drug may be allowed after consultation with the medical monitor;
- (19) Known history of severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies(CTCAE v5.0 Grade ≥3), or any component of the study drug;
- (20) Known alcohol and/or drug dependence, or any other condition deemed by the investigator to affect the safety or compliance of the study treatment, including but not limited to psychiatric disorders;
- (21) Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open, Multicenter, Phase I Clinical Study on the Safety, Efficacy, and Pharmacokinetics of SH009 Injection in Patients With Advanced Solid Tumors.
Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors
Read the detailed description
Based on the obtained data from the dose escalation phase of the Phase I clinical trial, select safe and effective tumor indications (including but not limited to gastric cancer, liver cancer, head and neck tumors, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) and dose levels for dose expansion studies. Further evaluate efficacy, safety, and pharmacokinetics to provide a basis for determining the recommended dose for Phase II clinical trials.
- Conditions
- Liver Cancer (Locally Advanced or Metastatic), Lung Cancer (NSCLC), Head and Neck Cancer Squamous Cell Carcinoma, Breast Cancer (Locally Advanced or Metastatic), Esophageal Cancer, Gastric Cancer (GC)
- Being tested
- SH009
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH009Drug
The dosage of SH009 is 40 mg/kg QW with a treatment cycle of 28 days
| Study group | Role | What they receive |
|---|---|---|
| SH009 | Experimental | Not described Receives: Drug: SH009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Proportion of subjects who have a complete or partial response as assessed according to RECIST v1.1
Measured: up to 2 years
Duration of response (DoR)
Duration of response (DoR), which is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Measured: up to 2 years
Time to response (TTR)
TTR is defined as the time to response base on RECIST v1.1
Measured: up to 2 years
Disease control rate (DCR)
Disease control rate (DCR), which is defined as the proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD), based on RECIST v1.1
Measured: up to 2 years
Progression-free survival (PFS)
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Measured: up to 2 years
Overall survival (OS)
From date of enrollment until the date of death from any cause
Measured: up to 2 years
Secondary outcomes (3)
Percentage of participants with adverse event (AE)
The percentage of participants experiencing an adverse event (AE) and the severity of AEs will be assessed
Measured: From the subject signs the Informed Consent Form to 30 days (AE) and 90 days (Serious AE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first,up to 2 years
Observed concentrations of SH009
The endpoints for assessment of Pharmacokinetics (PK) of SH009 include serum concentrations of SH009 at different timepoints after SH009 administration
Measured: From date of enrollment until the end of treatment, assessed up to 2 years
Number of participants who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of SH009 will be assessed by summarizing the number of participants who develop detectable antidrug antibodies (ADAs)
Measured: From first dose of SH009 through 90 days after last dose of SH009, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start16 May 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer (Locally Advanced or Metastatic)Studies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390838
- Sponsor's protocol ID
- SHS009-I-03
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter, Phase I Clinical Study on the Safety, Efficacy, and Pharmacokinetics of SH009 Injection in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT07390838
- Acronym / sponsor ID
- SHS009-I-03
- Conditions
- Liver Cancer (Locally Advanced or Metastatic), Lung Cancer (NSCLC), Head and Neck Cancer Squamous Cell Carcinoma, Breast Cancer (Locally Advanced or Metastatic), Esophageal Cancer, Gastric Cancer (GC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 May 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 5 Feb 2026 (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.
Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors
Detailed description
Based on the obtained data from the dose escalation phase of the Phase I clinical trial, select safe and effective tumor indications (including but not limited to gastric cancer, liver cancer, head and neck tumors, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) and dose levels for dose expansion studies. Further evaluate efficacy, safety, and pharmacokinetics to provide a basis for determining the recommended dose for Phase II clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SH009 | Experimental | Drug: SH009 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- (1) Age≥18 years old at the time of informed consent, male or female;
- (2) Subjects with histologically confirmed locally advanced, recurrent, or metastatic solid tumors (including but not limited to colorectal cancer, gastric cancer, hepatocellular carcinoma, head and neck cancer, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) who have experienced disease progression or intolerance to at least one prior line of systemic therapy, and for whom no acceptable standard therapy exists or who cannot benefit from or tolerate standard therapy;
- (3) Subjects must have at least one measurable lesion per RECIST 1.1 criteria. A lesion that has been previously irradiated can only be considered measurable if there is documented progression at that site following radiotherapy;
- (4) Archival tumor tissue samples are available, or the subject agrees to undergo a tumor biopsy for the determination of PD-L1 and CD47 expression levels and other biomarker analyses;
- (5) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
Key exclusion criteria (22 listed)
- (1) Prior exposure to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein;
- (2) Prior treatment with adoptive cellular therapies such as CAR-T, TCR-T, or TIL. Prior administration of an anti-cancer vaccine, or use of live or live-attenuated vaccines within 4 weeks prior to the first dose;
- (3) Systemic anti-tumor therapies within the specified timeframes prior to the first dose of study drug: Chemotherapy, antibody-based targeted therapy, endocrine therapy, or immunotherapy within 3 weeks. Mitomycin or nitrosoureas within 6 weeks. Oral fluoropyrimidines (e.g., S-1, capecitabine) and small molecule targeted agents within 2 weeks or 5 half-lives of the drug (whichever is longer).Chinese/herbal medicines with anti-cancer activity indicated in their labeling must be discontinued prior to enrollment. Prior radical radiotherapy within 3 months before study drug administration is excluded. Palliative radiotherapy administered within 2 weeks prior to dosing is allowed if the dose meets local palliative care standards and the radiation field covers less than 30% of the bone marrow area;
- (4) Received any investigational drug within 28 days before administration of this trial, or participated in another clinical study at the same time, except for the following circumstances: the patient participated in an observational, non-interventional clinical study, or was in the follow-up period after the end of treatment in an interventional clinical study but the drug withdrawal had exceeded the washout period;
- (5) Had major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first administration, or needed to undergo elective surgery during the trial period;
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 |
|---|---|---|
| SH009The dosage of SH009 is 40 mg/kg QW with a treatment cycle of 28 days | Drug | SH009 |
Primary outcome
Objective response rate (ORR)
Time frame: up to 2 years
Proportion of subjects who have a complete or partial response as assessed according to RECIST v1.1
Duration of response (DoR)
Time frame: up to 2 years
Duration of response (DoR), which is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first
Time to response (TTR)
Time frame: up to 2 years
TTR is defined as the time to response base on RECIST v1.1
Disease control rate (DCR)
Time frame: up to 2 years
Disease control rate (DCR), which is defined as the proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD), based on RECIST v1.1
Progression-free survival (PFS)
Time frame: up to 2 years
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Overall survival (OS)
Time frame: up to 2 years
From date of enrollment until the date of death from any cause
3 secondary outcomes
Percentage of participants with adverse event (AE)
Time frame: From the subject signs the Informed Consent Form to 30 days (AE) and 90 days (Serious AE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first,up to 2 years
Observed concentrations of SH009
Time frame: From date of enrollment until the end of treatment, assessed up to 2 years
Number of participants who develop detectable anti-drug antibodies (ADAs)
Time frame: From first dose of SH009 through 90 days after last dose of SH009, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SH009 in people with Liver Cancer (Locally Advanced or Metastatic) and Lung Cancer (NSCLC), run by Nanjing Sanhome Pharmaceutical, Co., 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 12 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 5 Feb 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Min (86-15121121360, minjie@sanhome.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 2 years). The study lists 6 primary outcomes in all. 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 5 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.