BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors
Trial Parameters
Brief Summary
This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment.
Eligibility Criteria
Inclusion Criteria: 1. Unresectable advanced or metastatic solid tumors, either refractory to standard therapy or ineligible for standard treatment. 2. ECOG performance status score of 0-2 point; 3. Expected survival of ≥3 months. 4. At least one measurable lesion by irRECIST criteria, and eligible for intratumoral injection. 5. Prior anti-tumor treatments should be paused for at least 4 weeks before trial initiation，with toxicity related to anti-cancer treatment recovered to ≤Grade 1. 6. Adequate organ and bone marrow function Exclusion Criteria: 1. Patients with active brain metastasis and/or leptomeningeal carcinomatosis，exempt for asymptomatic brain metastases or stable metastatic lesions for a minimum of 4 weeks. 2. Allergic: History of hypersensitivity to active ingredients or any other components of the study medication; cumulative two or more allergies to contrast agents, other drugs, or food. 3. Active hepatitis B or positive antibodies for hepatitis C, human immunodeficiency