Liver CancerPhase 1NCT07362264
A Study of SH006 Injection Combination Therapy in Patients With Advanced Solid Tumors
A Phase 1 study testing SH006 in people with Liver Cancer, run by Nanjing Sanhome Pharmaceutical, Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of the combination therapy of SH006 injection in patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- SH006
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is capable of comprehending the informed consent form, voluntarily agrees to participate, and signs the informed consent form.
- Age 18 to 75 years (inclusive) on the day of signing the informed consent form, both male and female.
- Patients with advanced solid tumors who have failed at least one line of standard therapy, or for whom no standard therapy exists, or for whom standard therapy is currently not applicable.
- According to RECIST 1.1 criteria, at least one measurable lesion at baseline (which has not been previously irradiated): accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (preferred with intravenous contrast) with a long diameter ≥10 mm (except for lymph nodes, whose short axis must be ≥15 mm), and the lesion is suitable for repeated measurement. Lesions previously irradiated can only be considered measurable if there is documented progression in the irradiated lesion or if the lesion persists for more than three months after radiotherapy, and it meets the RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Life expectancy ≥3 months, in the investigator's judgment.
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- Any toxicities from prior anti-tumor therapy have recovered to ≤ Grade 1 as per CTCAE v5.0, with the exception of alopecia, pigmentation, peripheral neuropathy ≤ Grade 2, hypothyroidism managed with hormone replacement, other confirmed chronic adverse events, or toxicities deemed by the investigator to pose no safety risk.
- Organ function levels must meet the following requirements (no blood transfusion, blood products, or hematopoietic growth factors for correction within 14 days prior to screening):Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥75×10⁹/L, hemoglobin (Hb) ≥90 g/L.
- Liver Function; Albumin (ALB) ≥28 g/L, total bilirubin (TBIL) ≤3× upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5×ULN;Renal Function: Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) >50 mL/min (calculated using the Cockcroft-Gault formula); Coagulation: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN; Urinalysis: Urine protein <2+; for subjects with urine protein ≥2+, a 24-hour urine collection must demonstrate a quantitative protein level <1 g/24 hours.
- For subjects who are hepatitis B surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive, HBV DNA must be <2000 IU/mL. They must continue or initiate anti-HBV therapy (e.g., entecavir, tenofovir disoproxil fumarate) throughout the study. For those not previously on antiviral therapy, it should be initiated within 1 week prior to the first dose or during the study as appropriate;For subjects who are hepatitis C virus antibody (HCV-Ab) positive, HCV RNA must be below the lower limit of detection.
- 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 prior to treatment initiation; male subjects must practice effective contraception from signing the informed consent until 6 months after the last dose.
- The subject is capable and willing to comply with the visits, treatment plan, laboratory tests, and other study-related procedures as specified in the study protocol.
Who cannot join
- Prior treatment with TIGIT inhibitors (including monoclonal antibodies, bispecific antibodies, or other agents).
- Administration of any investigational drug within 28 days prior to the first dose in this trial, or concurrent participation in another clinical study, with the following exceptions: participation in an observational, non-interventional clinical study, or being in the follow-up period of an interventional study where treatment ended more than the washout period (28 days after the last dose) ago.
- Within 3 weeks prior to the first dose in this trial: chemotherapy; or within 4 weeks prior: targeted therapy, endocrine therapy, or immunotherapy, except for the following: mitomycin or nitrosoureas within 6 weeks prior; oral fluoropyrimidines (e.g., S-1, capecitabine) and small-molecule targeted agents within 2 weeks prior. Prior use of traditional Chinese medicine/herbal medicine with anti-cancer activity described in its labeling is permitted, provided it is discontinued before the first dose of the study drug.
- Radical radiotherapy within 3 months prior to the first dose in this trial. Palliative radiotherapy within 2 weeks prior is allowed if the radiation dose meets local standards for palliative care and covers <30% of the bone marrow area.
- Major organ surgery (excluding needle biopsy) and/or local therapy within 28 days prior to the first dose, or unhealed wounds, active peptic ulcer, untreated fracture, or planned elective surgery during the study period.
- Central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention. Patients with previously treated brain metastases may be eligible if they are asymptomatic, show stable disease on imaging for ≥4 weeks prior to the first dose, and require no corticosteroids or anti-epileptic drugs.
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- History of allogeneic hematopoietic stem cell transplantation or organ transplantation (excluding corneal transplantation).
- Clinically uncontrollable third-space fluid collection (e.g., pleural effusion, ascites, pericardial effusion) not manageable by drainage or other methods prior to the first dose, as judged by the investigator.
- Co-infection with HBV and HCV; HIV antibody positive.
- Requirement for intravenous antibiotics for >7 days within 2 weeks prior to the first dose, systemic infection, or other severe infection.
- Hemorrhagic symptoms within 2 months prior to the first dose, such as hemoptysis (>2.5 mL of fresh blood) or history of gastrointestinal bleeding, as judged by the investigator to warrant exclusion.
- Patients with high bleeding risk indicated by endoscopy within 3 months prior to the first dose (e.g., moderate-to-severe red color signs on esophagogastric varices) or other conditions deemed by the investigator to confer bleeding risk (including active gastrointestinal ulcer, Crohn's disease, ulcerative colitis). The investigator will determine the need for endoscopy in other cases.
- Thrombolytic therapy (e.g., pro-urokinase, reteplase, alteplase, urokinase) or full-dose anticoagulation (e.g., unfractionated heparin) within 14 days prior to the first dose, excluding prophylactic anticoagulants like low-molecular-weight heparin.
- History of gastrointestinal perforation and/or fistula, abdominal abscess, or intestinal obstruction (including incomplete obstruction requiring parenteral nutrition) within 6 months prior to the first dose.
- Systemic glucocorticoid (>10 mg/day prednisone equivalent) or other immunosuppressant therapy within 14 days prior to the first dose, except: topical, ocular, intra-articular, intranasal, or inhaled glucocorticoids; short-term prophylactic use (e.g., for contrast media allergy).
- Severe respiratory disease or interstitial lung disease, as judged by the investigator to warrant exclusion.
- Anti-tuberculosis treatment within 1 year prior to the first dose.
- Administration of live (including attenuated) vaccines within 28 days prior to the first dose.
- Major vascular event (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to the first dose.
- Severe or uncontrolled systemic disease, including but not limited to: 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, uncorrectable hypokalemia, long QT syndrome, atrial fibrillation with resting heart rate >100 bpm, or severe valvular disease); clinically uncontrolled hypertension (SBP >150 mmHg and/or DBP >90 mmHg after treatment) as judged by the investigator.
- History of hypertensive crisis or hypertensive encephalopathy.
- History or presence of autoimmune disease within 2 years, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, Guillain-Barré syndrome, 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).
- Prior immunotherapy with ≥Grade 3 irAE or ≥Grade 2 immune-related myocarditis.
- History or presence of other malignancies, except: (i) cured early-stage malignancies (carcinoma in situ or Stage I), e.g., adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer; (ii) cured second primary cancer with no recurrence within 5 years; (iii) both primaries are expected to benefit from this study, per investigator.
- Known history of severe hypersensitivity to PD-1/PD-L1 antibodies, VEGF antibodies, or similar macromolecular agents, or severe hypersensitivity (CTCAE v5.0 Grade ≥3) to any component of the study drug.
- Pregnant or lactating women.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Multicenter, Phase I Clinical Study on the Safety, Efficacy, and Pharmacokinetics of SH006 Injection Combination in Patients With Advanced Solid Tumors
To evaluate the safety and tolerability of the combination therapy of SH006 injection in patients with advanced solid tumors
Read the detailed description
This is an open-label, multicenter study to evaluate the safety and efficacy of SH006 injection (15 mg/kg/30 mg/kg) in combination with bevacizumab/oxaliplatin/capecitabine in the treatment of patients with advanced solid tumors.
- Conditions
- Liver Cancer
- Being tested
- SH006
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SH006Drug
The dosage of SH006 is 15 mg/kg Q3W or 30 mg/kg Q3W, with a treatment cycle of 21 days
| Study group | Role | What they receive |
|---|---|---|
| SH006 (15mg/kg)/SH006 (30mg/kg)+Bevacizumab±Oxaliplatin±Capecitabine Tablet | Experimental | Not described Receives: Drug: SH006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Measured: Days 1-21
Recommended Phase 2 Dose (RP2D)
Measured: up to 21 days
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Measured: Within 90 days from the first administration to the last administration of the SH006 combination therapy
Secondary outcomes (10)
Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Measured: Every two cycles (each cycle lasting 21 days) until the end of treatment, with an average of 2 years.
Duration of Response (DOR) as Per RECIST v.1.1
Measured: Every two cycles (each cycle lasting 21 days) until the end of treatment, with an average of 2 years.
Progression Free Survival (PFS) as Per RECIST v.1.1
Measured: Every two cycles (each cycle lasting 21 days) until the end of treatment, with an average of 2 years.
DCR as Per RECIST v.1.1
Measured: Every two cycles (each cycle lasting 21 days) until the end of treatment, with an average of 2 years.
overall survival as Per RECIST v.1.1
Measured: Every 2 cycles (each cycle lasting 21 days) until the end of the treatment; Once every 12 weeks until the end of the follow-up, with an average of 2 years.
Maximum Concentration (Cmax) of SH006
Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Time of Maximum Concentration (Tmax) of SH006
Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Area Under the Curve (AUC) of SH006
Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Clearance (CL) of SH006
Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Evaluation of the immunogenicity of SH006
Serum sampling to assess the potential for anti-drug antibody (ADA) formation
Measured: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jul 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 CancerStudies 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
- 50 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
- NCT07362264
- Sponsor's protocol ID
- SHS006-I-02
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 23 Jan 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 23 Jan 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 SH006 Injection Combination in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07362264
- Acronym / sponsor ID
- SHS006-I-02
- Conditions
- Liver Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nanjing Sanhome Pharmaceutical, Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 23 Jan 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.
To evaluate the safety and tolerability of the combination therapy of SH006 injection in patients with advanced solid tumors
Detailed description
This is an open-label, multicenter study to evaluate the safety and efficacy of SH006 injection (15 mg/kg/30 mg/kg) in combination with bevacizumab/oxaliplatin/capecitabine in the treatment of patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SH006 (15mg/kg)/SH006 (30mg/kg)+Bevacizumab±Oxaliplatin±Capecitabine Tablet | Experimental | Drug: SH006 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The subject is capable of comprehending the informed consent form, voluntarily agrees to participate, and signs the informed consent form.
- Age 18 to 75 years (inclusive) on the day of signing the informed consent form, both male and female.
- Patients with advanced solid tumors who have failed at least one line of standard therapy, or for whom no standard therapy exists, or for whom standard therapy is currently not applicable.
- According to RECIST 1.1 criteria, at least one measurable lesion at baseline (which has not been previously irradiated): accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) (preferred with intravenous contrast) with a long diameter ≥10 mm (except for lymph nodes, whose short axis must be ≥15 mm), and the lesion is suitable for repeated measurement. Lesions previously irradiated can only be considered measurable if there is documented progression in the irradiated lesion or if the lesion persists for more than three months after radiotherapy, and it meets the RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
Key exclusion criteria (27 listed)
- Prior treatment with TIGIT inhibitors (including monoclonal antibodies, bispecific antibodies, or other agents).
- Administration of any investigational drug within 28 days prior to the first dose in this trial, or concurrent participation in another clinical study, with the following exceptions: participation in an observational, non-interventional clinical study, or being in the follow-up period of an interventional study where treatment ended more than the washout period (28 days after the last dose) ago.
- Within 3 weeks prior to the first dose in this trial: chemotherapy; or within 4 weeks prior: targeted therapy, endocrine therapy, or immunotherapy, except for the following: mitomycin or nitrosoureas within 6 weeks prior; oral fluoropyrimidines (e.g., S-1, capecitabine) and small-molecule targeted agents within 2 weeks prior. Prior use of traditional Chinese medicine/herbal medicine with anti-cancer activity described in its labeling is permitted, provided it is discontinued before the first dose of the study drug.
- Radical radiotherapy within 3 months prior to the first dose in this trial. Palliative radiotherapy within 2 weeks prior is allowed if the radiation dose meets local standards for palliative care and covers <30% of the bone marrow area.
- Major organ surgery (excluding needle biopsy) and/or local therapy within 28 days prior to the first dose, or unhealed wounds, active peptic ulcer, untreated fracture, or planned elective surgery during the study 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 |
|---|---|---|
| SH006The dosage of SH006 is 15 mg/kg Q3W or 30 mg/kg Q3W, with a treatment cycle of 21 days | Drug | SH006 (15mg/kg)/SH006 (30mg/kg)+Bevacizumab±Oxaliplatin±Capecitabine Tablet |
Primary outcome
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Days 1-21
Recommended Phase 2 Dose (RP2D)
Time frame: up to 21 days
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Within 90 days from the first administration to the last administration of the SH006 combination therapy
10 secondary outcomes
Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Time frame: Every two cycles (each cycle lasting 21 days) until the end of treatment, with an average of 2 years.
Duration of Response (DOR) as Per RECIST v.1.1
Time frame: Every two cycles (each cycle lasting 21 days) until the end of treatment, with an average of 2 years.
Progression Free Survival (PFS) as Per RECIST v.1.1
Time frame: Every two cycles (each cycle lasting 21 days) until the end of treatment, with an average of 2 years.
DCR as Per RECIST v.1.1
Time frame: Every two cycles (each cycle lasting 21 days) until the end of treatment, with an average of 2 years.
overall survival as Per RECIST v.1.1
Time frame: Every 2 cycles (each cycle lasting 21 days) until the end of the treatment; Once every 12 weeks until the end of the follow-up, with an average of 2 years.
Maximum Concentration (Cmax) of SH006
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Time of Maximum Concentration (Tmax) of SH006
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Area Under the Curve (AUC) of SH006
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Clearance (CL) of SH006
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
Evaluation of the immunogenicity of SH006
Time frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
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 23 Jan 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 SH006 in people with Liver Cancer, 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 27 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 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?
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?
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Days 1-21). The study lists 3 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 23 Jan 2026.