A Study of the ILB-3101 in Patients with Advanced Solid Tumors
Trial Parameters
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Brief Summary
ILB-3101 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of ILB-3101 in Chinese advanced solid tumor patients.
Eligibility Criteria
Inclusion Criteria: 1. Have signed informed consent forms voluntarily. 2. 18-80 years old. 3. Having an ECOG performance status score of 0 or 1. 4. With an expected survival of more than 12 weeks. 5. Diagnosed histologically or cytologically with local advanced or metastatic solid cancer, and under one of following situations: standard treatment-refractory (disease progression or no response), treatment-resistant, unable to receive treatment, or the standard treatment is unavailable. 6. Need to provide archived tumor tissue samples (Formalin fixed or paraffin embedded tissue blocks or at least 5 unstained sections); During the dose escalation stage, for subjects who are unable to provide tumor samples or have insufficient samples, the decision to enroll may be made based on specific circumstances after discussion with the sponsor. 7. At least one assessable tumor lesion is present during the dose escalation phase, and according to RECIST version 1.1, at least one measurable tumor lesio