HX009+ IN10018 with or Without Standard Chemotherapy for Advanced Solid Tumours

Inclusion Criteria:

1. Voluntarily participate in the trial and sign the informed consent form;

2. male or female, age at 18 to 70 years (including borderline value) ;

3. expected survival ≥ 12 weeks;

4. ECOG score 0-1;

5. patients with unresectable/metastatic advanced solid tumours (including biliarytract malignancies and malignant melanoma) confirmed by cytology or histopathology;Part I: Failed standard therapy, or no effective standard therapy (prior treatmentwith anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies may be eligible forenrolment); Part II: No prior systemic therapy (prior neoadjuvant and adjuvanttherapy is permitted, but needs to have been completed at least 6 months ago);

Exclusion Criteria:

1. Histological or pathological diagnosis of carcinoma of the jugular abdomen;

2. Patients with melanoma with known BRAF v600E mutation and NRAS mutation; patientswith cholangiocarcinoma and gallbladder cancer with known BRAF v600E mutation, NTRKgene fusion, RET gene fusion mutation, FGFR2 gene fusion, IDH1 gene mutation, andKRAS mutation

3. Subjects with symptomatic brain metastases, meningeal metastases, or spinal cordcompression, except for the following: asymptomatic brain metastases (i.e., noprogressive central nervous system symptoms caused by brain metastases, no need forcorticosteroid or antiepileptic drugs, and the lesion has been stable for ≥4 weeksas confirmed by imaging tests);

4. have had a malignancy other than the study disease (biliary malignancy, malignantmelanoma) within 5 years prior to signing the ICF, except for malignancies withnegligible risk of metastasis or death and/or those that have received curativetreatment (e.g. adequately treated cervical carcinoma in situ, basal or squamouscell skin carcinoma, confined prostate cancer, ductal carcinoma in situ, or stage Iuterine cancer);

5. Subjects with an active, or history of, autoimmune disease that is likely to recuror is currently being treated (e.g., systemic lupus erythematosus, rheumatoidarthritis, inflammatory bowel disease, autoimmune thyroid disease, multiplesclerosis, vasculitis, glomerulonephritis, etc.), or at high risk (e.g., organtransplants requiring immunosuppressive therapy). However, subjects with thefollowing diseases were allowed to enrol:

• Type 1 diabetes mellitus that has stabilised with the use of fixed doses ofinsulin;

• Autoimmune hypothyroidism and adrenal insufficiency requiring only hormonereplacement therapy;

• Skin diseases that do not require systemic therapy: e.g. eczema, rashes thatcover less than 10 per cent of the body surface, psoriasis without ocularsymptoms.

6. have severe cardiovascular disease such as symptomatic congestive heart failure (NewYork Heart Association Class III or IV), unstable angina, uncontrolled hypertension (systolic blood pressure ≥160 and/or diastolic blood pressure ≥100 mmHg underpharmacological control), cardiac arrhythmia, history of myocardial infarctionwithin 6 months, or history of arterial thromboembolism or pulmonary embolism within 3 months prior to the first administration of the drug

7. suffering from a serious lung disease requiring treatment or previous serious lungdisease, interstitial lung disease, interstitial pneumonitis, pulmonary fibrosis,radiation pneumonitis requiring hormonal therapy, etc;

8. uncontrolled concomitant medical conditions including, but not limited to, severediabetes mellitus (fasting blood glucose > 250 mg/dl or 13.9 mmol/L), activeinfectious diseases, psychiatric disorders (e.g., epilepsy) that may interfere withadherence, or other serious conditions requiring systemic therapy

9. patient with uncontrolled pleural effusions, abdominal effusions or pericardialeffusions that require repeated drainage. Individuals with indwelling drains arepermitted to be enrolled;