HX009+ IN10018 with or Without Standard Chemotherapy for Advanced Solid Tumours
Trial Parameters
Brief Summary
Phase IIa study of HX009+ IN10018 in combination with or without standard chemotherapy in patients with advanced solid tumours including biliary tract malignancies and malignant melanoma
Eligibility Criteria
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 biliary tract malignancies and malignant melanoma) confirmed by cytology or histopathology; Part I: Failed standard therapy, or no effective standard therapy (prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies may be eligible for enrolment); Part II: No prior systemic therapy (prior neoadjuvant and adjuvant therapy 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; patients with cholangiocarcinoma and gallbladder cancer with known BRAF v600E mutation, NTRK gene fusion, RET gene fusion m