A Safety and Efficacy Study of XH001 Combined With Sintilimab Injection in Advanced Solid Tumors

Inclusion Criteria:

• Is willing and able to provide written informed consent for the trial.
• Is ≥18 years and ≤ 75 years of age on day of signing informed consent.
• Has a histologically confirmed advanced solid tumor. Subjects must have documentedprogression after standard therapy or is intolerant of, refuses, or is not eligiblefor standard therapy.
• Has at least 1 measurable disease lesion as defined by Response Evaluation Criteria inSolid Tumors.
• Has a life expectancy of ≥12 weeks.
• Has an ECOG performance status of 0-1.
• Has adequate organ function as confirmed by laboratory values listed in the main bodyof the protocol

Exclusion Criteria:

• Subject who need to receive systemic application of anti-allergic drugs for a longtime, or have a history of life-threatening allergic reactions to any vaccine or drug;
• Symptomatic or rapidly progressive central nervous system metastases. Patients withextensive lung metastases resulting in dyspnea; patients with tumors close to orinvading major blood vessels or nerves;
• New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, andtransient ischemic attack) within 6 months before screening;
• Subject with acute myocardial infarction within 6 months before screening, oruncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3,New York Heart Association Heart Failure Classification Criteria NYHA Class ≥ III) andother cardiovascular diseases;
• Subject who have received treatment with immunomodulatory drugs 4 times before thefirst vaccination day (D1), including but not limited to: IL-2, CTLA-4 inhibitors,CD40 agonists, CD137 agonists, IFN-α (except for high-risk surgical subjects who useIFN-α as adjuvant therapy, if IFN-α treatment is stopped 4 times before this trial);
• Subject who received blood transfusion, erythropoietin (EPO), granulocytecolony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) before baseline;
• Subject with skin diseases (e.g., psoriasis) at baseline that may prevent theintradermal injection of vaccine into the target area;
• Subject still suffer from adverse reactions (except alopecia and platinum-inducedneurotoxicity ≤ grade 2) that have not been restored to CTCAE version 5.0 grade ≤ 1after previous anti-tumor treatment during the screening period;
• Concomitant use of steroid hormone drugs (tumor or non-tumor related diseases) isrequired; however, topical application (not applied to the vaccination site) orinhaled steroid drugs are required;
• Subject has an active infection or uncontrollable infection (except for simple urinarytract infection or upper respiratory tract infection) requiring systemic treatment;
• Subjects with positive human immunodeficiency virus antibody, hepatitis B surfaceantigen and/or hepatitis B core antibody and positive hepatitis B virusdeoxyribonucleic acid > 1000 IU/mL, hepatitis C virus antibody, Treponemapallidum-specific antibody in virological monitoring during the screening period;
• Hypertension poorly controlled on treatment (defined as systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 100 mmHg);
• Subject with other malignant tumors within 5 years before the screening period, exceptfor cervical carcinoma in situ, breast carcinoma in situ and cutaneous basal cellcarcinoma that have received appropriate treatment and met the recovery criteria;
• Subject with a history of autoimmune diseases [such as, but not limited to:interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis,nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptomsor hypothyroidism caused by chemoradiotherapy can be included), subjects with vitiligoor recovered asthma can be included without any intervention, and subjects with asthmarequiring bronchodilators for medical intervention cannot be included];
• Subject who has previously received similar therapeutic tumor vaccines;
• Subject with congenital or acquired immunodeficiency;
• Subject still participating in other clinical trials and not enrolled at the screeningperiod;
• Subject who is unable or unwilling to comply with the study protocol due to potentialhealth, mental or social conditions in the opinion of the investigator;
• Other conditions that, in the opinion of the investigator, would make participation inthis study inappropriate.